^
10h
P1, N=136, Recruiting, AstraZeneca | Active, not recruiting --> Recruiting | Trial completion date: Jul 2023 --> Dec 2023 | Trial primary completion date: Jul 2023 --> Dec 2023
Clinical • Enrollment open • Trial completion date • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ALK (Anaplastic lymphoma kinase) • EML4 (EMAP Like 4)
|
EGFR mutation • EML4-ALK fusion • ALK fusion
|
cisplatin • carboplatin • Imfinzi (durvalumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • pemetrexed
12h
Clinical • Enrollment open • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Tecentriq (atezolizumab) • Hyleukin-7 (efineptakin alfa)
2d
P2, N=200, Recruiting, Seagen Inc. | Not yet recruiting --> Recruiting
Clinical • Enrollment open • Combination therapy • Pan tumor
|
BRAF (B-raf proto-oncogene)
|
BRAF mutation
|
Keytruda (pembrolizumab) • carboplatin • pemetrexed • SEA-CD40
3d
P3, N=651, Completed, Bio-Thera Solutions | Recruiting --> Completed | Trial completion date: Mar 2020 --> May 2021
Clinical • Trial completion • Trial completion date
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK mutation
|
carboplatin • paclitaxel • BAT1706 (bevacizumab biosimilar)
4d
P1, N=225, Recruiting, AbbVie | Trial completion date: Jun 2022 --> Dec 2024 | Trial primary completion date: Feb 2022 --> Jun 2022
Clinical • Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
|
EGFR mutation • EGFR L858R
|
Opdivo (nivolumab) • erlotinib • Tagrisso (osimertinib) • telisotuzumab vedotin (ABBV-399)
4d
Patients with non-small cell lung cancer (NSCLC) harboring ROS proto-oncogene 1 (ROS1) gene rearrangements show dramatic response to the tyrosine kinase inhibitor (TKI) crizotinib...As NSCLC can demonstrate ROS1 IHC positivity in FISH-negative cases, the degree of the specificity of the IHC assay, especially in highly sensitive protocols, is mostly dependent on the readout cut-off threshold. As ROS1 IHC is a screening assay for a rare rearrangements in NSCLC, we recommend adjustment of the readout threshold in order to balance specificity, rather than decreasing the overall analytical and diagnostic sensitivity of the protocols.
Clinical • Journal
|
ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
ROS1 positive • ROS1 fusion • ROS1 rearrangement
|
Xalkori (crizotinib)
5d
Clinical • Journal
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS G12D • KRAS G12
7d
P1/2, N=162, Recruiting, BeiGene | Trial completion date: Sep 2023 --> Jan 2024 | Trial primary completion date: Mar 2023 --> Jul 2023
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Baize’an (tislelizumab) • BGB-A425
8d
P=N/A, N=825, Recruiting, Boehringer Ingelheim | Trial completion date: Oct 2025 --> Aug 2026 | Trial primary completion date: Dec 2023 --> Aug 2026
Clinical • Trial completion date • Trial primary completion date • Real-world evidence
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
Gilotrif (afatinib)
9d
For most populations, DICI+chemotherapy could be the best choice with a survival benefit, while SICI+chemotherapy has established its position actually. [PROSPERO], identifier [CRD42020184534].
Retrospective data • Review • Checkpoint inhibition • Tumor Mutational Burden • PD(L)-1 Biomarker • IO biomarker
|
TMB (Tumor Mutational Burden)
|
PD-L1 expression • TMB-H • TMB-L
12d
The TASUKI-52 regimen should be considered a viable new treatment strategy for treatment-naïve patients with advanced non-squamous NSCLC.
Clinical • Journal • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
PD-L1 expression • PD-L1 negative
|
Opdivo (nivolumab) • Avastin (bevacizumab) • carboplatin • paclitaxel
14d
Clinical • New P3 trial
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
KRAS mutation • EGFR mutation • ALK rearrangement • ALK mutation
|
Keytruda (pembrolizumab)
15d
P2, N=25, Active, not recruiting, Joel Neal | Trial completion date: Sep 2022 --> Apr 2022 | Trial primary completion date: Sep 2021 --> Mar 2021
Clinical • Trial completion date • Trial primary completion date • Circulating tumor DNA
|
PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression • EGFR mutation • ALK rearrangement
|
Keytruda (pembrolizumab)
15d
P2, N=14, Active, not recruiting, Sidney Kimmel Cancer Center at Thomas Jefferson University | Trial primary completion date: Jul 2021 --> Jul 2022
Clinical • Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
Opdivo (nivolumab) • cisplatin • gemcitabine • pemetrexed
15d
P1, N=305, Recruiting, Boehringer Ingelheim | Trial completion date: Dec 2021 --> Jul 2023 | Trial primary completion date: Aug 2021 --> Mar 2023
Clinical • Trial completion date • Trial primary completion date • Combination therapy • PD(L)-1 companion diagnostic
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
BI 836880 • ezabenlimab (BI 754091)
16d
P2, N=42, Not yet recruiting, Georgetown University | Initiation date: Jul 2021 --> Oct 2021
Clinical • Trial initiation date
|
ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
PD-L1 expression
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • tiragolumab (MTIG7192A)
16d
Clinical • New P1 trial • Adverse events
|
MET (MET proto-oncogene, receptor tyrosine kinase)
|
MET positive
|
ABBV-400
16d
Among NSCLC patients treated with 1L pembrolizumab, high PD-L1 TPS is associated with OS among patients with nonsquamous NSCLC, but not among patients with squamous NSCLC.
Clinical • Journal • Tumor proportion score • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • PD-1 (Programmed cell death 1)
|
PD-L1 expression • PD-1 expression
|
Keytruda (pembrolizumab)
19d
Moreover, high miR-202 independently predicted shorter OS (HR: 1.989; p = 0.008) in the non-squamous (non-SqCC) subgroup, and high miR-26a was correlated with shorter OS in the squamous (SqCC) subgroup (10.07 vs. 13.53 months, p = 0.033). The results of the present study propose that the expression levels of circulating miRNAs involved in macrophage polarization are correlated with survival measures in NSCLC patients, and their role as potential biomarkers merits further investigation.
Journal
|
Let-7c (MicroRNA Let-7c) • MIR30D (MicroRNA 30d) • MIR195 (MicroRNA 195)
20d
P1, N=172, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Aug 2021 --> Dec 2022 | Trial primary completion date: Aug 2021 --> Dec 2022
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
|
PD-L1 expression • TMB-H • MSI-H/dMMR • PD-L1 overexpression
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
21d
P3, N=1193, Recruiting, AstraZeneca | Trial completion date: Apr 2024 --> Aug 2024 | Trial primary completion date: Apr 2024 --> Mar 2021
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK fusion
|
cisplatin • carboplatin • gemcitabine • Imfinzi (durvalumab) • Abraxane (albumin-bound paclitaxel) • tremelimumab (CP-675206) • pemetrexed
22d
P2, N=30, Recruiting, Sun Yat-sen University | Active, not recruiting --> Recruiting
Clinical • Enrollment open
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR T790M • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR L861Q • EGFR G719X
|
cisplatin • Tagrisso (osimertinib) • pemetrexed
22d
Teliso-V monotherapy was tolerated and showed antitumor activity in c-Met+ NSCLC. On the basis of overall safety, pharmacokinetics, and efficacy outcomes, 1.9 mg/kg Teliso-V Q2W and 2.7 mg/kg Q3W schedules were selected for further clinical development.
Clinical • P1 data • Journal
|
MET (MET proto-oncogene, receptor tyrosine kinase)
|
MET amplification • MET exon 14 mutation
|
telisotuzumab vedotin (ABBV-399)
22d
P2b, N=145, Active, not recruiting, ImmunityBio, Inc. | Trial completion date: Aug 2021 --> Dec 2023 | Trial primary completion date: Jun 2021 --> May 2023
Clinical • Trial completion date • Trial primary completion date • Checkpoint inhibition
|
BRAF (B-raf proto-oncogene) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability)
|
PD-L1 expression • BRAF V600E • MSI-H/dMMR • PD-L1 overexpression • BRAF V600
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • Anktiva (inbakicept) • PD-L1.t-haNK
23d
The poor outcomes associated with KRAS p.G12C mutated advanced NSCLC indicate an unmet need for more effective novel treatments.
Observational data • Retrospective data • Journal • IO biomarker
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • STK11 (Serine/threonine kinase 11) • KEAP1 (Kelch Like ECH Associated Protein 1)
|
TP53 mutation • KRAS mutation • EGFR mutation • KRAS G12C • STK11 mutation • KEAP1 mutation • KRAS G12
25d
P2, N=30, Active, not recruiting, Nasser Hanna | Trial completion date: Jul 2022 --> Dec 2022 | Trial primary completion date: Jul 2021 --> Dec 2021
Clinical • Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
PD-L1 expression • EGFR mutation • BRAF mutation • PD-L1 negative • ALK translocation
|
Avastin (bevacizumab) • carboplatin • Tecentriq (atezolizumab) • pemetrexed
27d
All patients received pemetrexed 500 mg/m plus the investigator's choice of cisplatin or carboplatin Q3W for four cycles, followed by maintenance pemetrexed 500 mg/m Q3W (all intravenous). Grade 3/4 AEs occurred in 72% versus 60% of patients in the pembrolizumab versus placebo arms; 40% versus 20% had immune-mediated AEs, and 4% versus 0% had infusion reactions. Efficacy and safety outcomes were similar to those from the global study and support first-line therapy with pembrolizumab plus pemetrexed-platinum in Japanese patients with nonsquamous NSCLC without EGFR/ALK alterations.
Clinical • Journal
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed
28d
Clinical • Enrollment open
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK fusion
|
Keytruda (pembrolizumab) • Focus V (anlotinib) • APL-502
28d
Clinical • New P2 trial
|
PD-L1 (Programmed death ligand 1)
|
Baize’an (tislelizumab) • ociperlimab (BGB-A1217)
28d
P2, N=21, Active, not recruiting, Washington University School of Medicine | Trial completion date: Jul 2023 --> Dec 2023
Trial completion date • Checkpoint inhibition
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK mutation
|
Tecentriq (atezolizumab) • Cyramza (ramucirumab)
29d
Approximately 625 patients will be randomized 1:2:2 into Arm A (carboplatin + paclitaxel or pemetrexed), Arm B (zimberelimab monotherapy: 360 mg intravenously [IV] once every 3 weeks [Q3W]), and Arm C (zimberelimab: 360 mg IV Q3W + domvanalimab: 15 mg/kg IV Q3W). Arm A patients may crossover to Arm B upon documented PD; however, no crossover is allowed from Arm B to Arm C. For Arm A vs Arm B, the primary endpoint is overall survival (OS) and for Arm B vs Arm C, the co-primary endpoints are investigator-assessed PFS and OS; additional endpoints include quality of life assessments and safety. Study recruitment is planned in Asia, Latin America, Africa, and Eastern Europe.
P3 data • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • NTRK (Neurotrophic receptor tyrosine kinase)
|
PD-L1 overexpression • PD-L1-H
|
carboplatin • paclitaxel • pemetrexed • zimberelimab (AB122) • domvanalimab (AB154)
29d
Our study shows detrimental effects of docetaxel plus intercalated erlotinib, and strongly discourages further exploration of this combination in clinical practice.
Clinical • P3 data • Journal
|
EGFR (Epidermal growth factor receptor)
|
erlotinib • docetaxel
29d
Clinical • Trial primary completion date • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • Tecentriq (atezolizumab) • pemetrexed • tiragolumab (MTIG7192A)
29d
P1b, N=50, Active, not recruiting, National Cancer Institute (NCI) | Trial primary completion date: Jul 2021 --> Jul 2022
Clinical • Trial primary completion date • Combination therapy • IO biomarker
|
EGFR (Epidermal growth factor receptor) • BCL2 (B-cell CLL/lymphoma 2) • BCL2L1 (BCL2-like 1) • BCL2L11 (BCL2 Like 11)
|
EGFR mutation • EGFR L858R • EGFR T790M • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X
|
Tagrisso (osimertinib) • navitoclax (ABT 263)
29d
P1/2, N=86, Not yet recruiting, Cancer Research UK | Initiation date: May 2021 --> Sep 2021
Trial initiation date • Checkpoint inhibition
|
PD-L1 (Programmed death ligand 1) • MAGEA3 (MAGE Family Member A3)
|
VTP-600
29d
Clinical • Trial initiation date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
cisplatin • carboplatin • pemetrexed • dexamethasone • cosibelimab (CK-301)
29d
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
CEACAM5 (CEA Cell Adhesion Molecule 5)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • tusamitamab ravtansine (SAR408701)
29d
P2, N=36, Recruiting, Sanofi | Trial completion date: Feb 2022 --> Aug 2022 | Trial primary completion date: Oct 2021 --> Apr 2022
Clinical • Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition
|
CEACAM5 (CEA Cell Adhesion Molecule 5)
|
Cyramza (ramucirumab) • tusamitamab ravtansine (SAR408701)
29d
Clinical • Trial completion date • IO biomarker
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
VENTANA PD-L1 (SP263) Assay
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • paclitaxel • gemcitabine • pemetrexed
29d
P3, N=460, Recruiting, UNICANCER | Trial completion date: May 2023 --> Sep 2024 | Trial primary completion date: May 2022 --> Mar 2024
Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK positive • ALK translocation
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • Abraxane (albumin-bound paclitaxel) • pemetrexed
29d
P2, N=118, Active, not recruiting, Merck Sharp & Dohme Corp. | Trial completion date: Aug 2021 --> Aug 2023
Clinical • Trial completion date
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR mutation • BRAF mutation • ALK rearrangement
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed
29d
P2, N=16, Active, not recruiting, Wake Forest University Health Sciences | Trial completion date: Jul 2021 --> Jul 2022
Clinical • Trial completion date
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
ROS1 mutation
|
pemetrexed
29d
Clinical • Trial completion date • Combination therapy • IO biomarker
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden)
|
PD-L1 expression • EGFR mutation • ALK fusion
|
VENTANA PD-L1 (SP263) Assay
|
cisplatin • carboplatin • Tecentriq (atezolizumab) • gemcitabine • pemetrexed
29d
P2, N=20, Recruiting, Sarah Sammons, MD | N=40 --> 20
Clinical • Enrollment change
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
PD-L1 expression • EGFR mutation • ALK mutation
|
Opdivo (nivolumab) • Yervoy (ipilimumab)
29d
P1/2, N=170, Recruiting, Bristol-Myers Squibb | N=60 --> 170 | Trial completion date: Oct 2024 --> Jul 2025 | Trial primary completion date: Sep 2021 --> Oct 2022
Enrollment change • Trial completion date • Trial primary completion date • Pan tumor
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Opdivo (nivolumab) • nivolumab subcutaneous (BMS-986298)
29d
P1/2, N=140, Recruiting, Cantargia AB | N=100 --> 140 | Trial completion date: Jun 2021 --> Oct 2022 | Trial primary completion date: Dec 2020 --> Mar 2022
Clinical • Enrollment change • Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation
|
cisplatin • gemcitabine • Abraxane (albumin-bound paclitaxel) • nidanilimab (CAN04)
29d
Clinical • Enrollment change • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • paclitaxel • lenvatinib • pemetrexed • MK-4830
30d
Clinical • New P2 trial
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR T790M • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR L861Q • EGFR G719X
|
cisplatin • Tagrisso (osimertinib) • pemetrexed
1m
Clinical • New P2 trial • Checkpoint inhibition
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR mutation • ALK rearrangement • ROS1 rearrangement
|
Tecentriq (atezolizumab) • Cyramza (ramucirumab) • Anktiva (inbakicept)
1m
Clinical • Combination therapy • Real-world evidence • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • PD-L1 overexpression
1m
High pre-treatment circulating levels of VEGF-A were associated with shorter progression-free survival (p = 0.036). In conclusion, in this prospective study, genetic variants in VEGFR-1 and VEGF-A and plasma levels of VEGF-A were associated with clinical benefit, progression-free survival, or overall survival in a cohort of advanced non-squamous non-small-cell lung cancer patients receiving chemotherapy plus antiangiogenic therapy.
Clinical • Journal
|
KDR (Kinase insert domain receptor) • FLT1 (Fms-related tyrosine kinase 1)
|
KDR expression
|
Avastin (bevacizumab)
1m
ADIPemCis was safe and highly active in patients with ASS1-deficient non-squamous NSCLC, however, survival was poor overall. ASS1 loss was co-associated with p53 mutations. Therapies incorporating pegargiminase merit further evaluation in ASS1-deficient and treatment-refractory NSCLC.
Clinical • P1 data • Journal • PD(L)-1 Biomarker • IO biomarker
|
KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • ASS1 (Argininosuccinate synthase 1)
|
PD-L1 expression • TP53 mutation • KRAS mutation
|
Keytruda (pembrolizumab) • cisplatin • pemetrexed • Hepacid (pegargiminase)
1m
Clinical • Trial completion
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • Yervoy (ipilimumab) • Libtayo (cemiplimab)
1m
Using an external cohort of 154 patients, we confirmed the independent prognostic role of TTF1. TTF1 expression and PD-L1 can be used to stratify risk and predict PFS and OS in patients treated with ICI for NS-NSCLC.
Clinical • Journal • PD(L)-1 Biomarker • IO biomarker
|
KRAS (KRAS proto-oncogene GTPase) • NKX2-1 (NK2 Homeobox 1)
|
PD-L1 expression • KRAS mutation • NKX2-1 expression
1m
P2, N=40, Recruiting, The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting --> Recruiting
Clinical • Enrollment open
|
ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
ALK mutation • ROS1 mutation
|
cisplatin • carboplatin • Focus V (anlotinib) • Abraxane (albumin-bound paclitaxel) • Tyvyt (sintilimab) • pemetrexed
1m
Clinical • Enrollment open • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
zimberelimab (AB122) • domvanalimab (AB154) • etrumadenant (AB928)
1m
P2, N=59, Completed, University Hospital, Limoges | Active, not recruiting --> Completed | Trial completion date: Jun 2020 --> Sep 2020 | Trial primary completion date: Jan 2020 --> Sep 2020
Clinical • Trial completion • Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK rearrangement
|
docetaxel • nintedanib
1m
P2, N=41, Active, not recruiting, Fundación GECP | Recruiting --> Active, not recruiting | N=102 --> 41
Clinical • Enrollment closed • Enrollment change • Combination therapy
|
TMB (Tumor Mutational Burden)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab)
1m
P2, N=15, Not yet recruiting, Frame Pharmaceuticals B.V.
New P2 trial
|
CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • CD4 (CD4 Molecule)
|
Keytruda (pembrolizumab) • FRAME-001
1m
DetermaRx is a 14-gene molecular stratification test that has been validated in over 1400 patients, and outperformed NCCN criteria in identifying patients at high risk for mortaility from stage IA, IB, and IIA non-squamous NSCLC. Oncocyte now offers DetermaRx+EGFR testing to provide a complete molecular testing solution in early-stage NSCLC, guiding treatment selection of targeted therapy and adjuvant chemotherapy.
EGFR (Epidermal growth factor receptor)
|
DetermaRx™
1m
No mutations were found in 27 cases (49.1%). Table: Detected aberrations (per sample) Conclusion For patients in whom molecular analysis on tissue cannot be performed, NGS analysis of cfDNA in plasma provides an opportunity to detect driver mutations for subsequent targeted therapy.
Next-generation sequencing
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
|
TP53 mutation • BRAF mutation • PIK3CA mutation • KRAS G12C • EGFR exon 19 deletion • EGFR exon 20 insertion • KRAS G12 • BRAF G466V
|
CELLSEARCH® • Oncomine™ Lung cfDNA Assay
1m
Patients will be randomized 1:1 to receive telaglenastat (800 mg BID PO) or placebo, plus pembro, carboplatin, and pemetrexed at standard doses on day 1 of each 21-day cycle. A separate screening protocol (NCT04698681) is also available to assess KEAP1or NRF2 mutational status based on liquid biopsy NGS, which may be used to determine KEAPSAKE trial eligibility of patients whose mutational status is unknown. https://clinicaltrials.gov/ct2/show/NCT04265534.
Clinical • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • STK11 (Serine/threonine kinase 11) • KEAP1 (Kelch Like ECH Associated Protein 1) • NFE2L2 (Nuclear Factor, Erythroid 2 Like 2)
|
EGFR mutation • STK11 mutation • KEAP1 mutation • ALK mutation • NFE2L2 mutation
|
Keytruda (pembrolizumab) • carboplatin • pemetrexed • telaglenastat (CB-839)
1m
Introduction The phase III ADAURA trial showed a significant disease-free survival (DFS) benefit for adjuvant osimertinib versus placebo in resected stage IB-IIIA EGFR mutated non-small cell lung cancer (NSCLC)...Conclusion Clinico-demographic characteristics and early survival outcomes of patients with EGFR-positive NSCLC in our Princess Margaret Cancer Centre cohort were very similar to the placebo-controlled arm of the ADAURA trial. With the longer follow-up available in our cohort, we anticipate that that the placebo-controlled arm of ADAURA will also demonstrate growing numbers of recurrences and deaths.
Clinical • Clinical data
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
Tagrisso (osimertinib)
1m
Pembrolizumab in combination with chemotherapy resulted in a gain of 0.17 QALYs and generated incremental costs of 81,085 CHF as compared to pembrolizumab alone, resulting in an ICER of 475,299 CHF/QALY. Conclusion While pembrolizumab monotherapy is cost-effective from a Swiss perspective, the combination therapy with pembrolizumab and chemotherapy is not.
HEOR • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab)
1m
The most common ICIs received by Exon20ins and wt-NSCLC patients were nivolumab (64% and 51%) and pembrolizumab (32% and 42%), respectively. Conclusion ICI therapy was less effective for patients with Exon20ins compared with wt-NSCLC, although the sample size for Exon20ins NSCLC was smaller. The limited effectiveness of current treatment options for patients with EGFR Exon20ins NSCLC stress the need for new targeted therapies.
Clinical • Clinical data • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker • EGFR exon 20
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
|
Keytruda (pembrolizumab) • Opdivo (nivolumab)
1m
Patients in the chemotherapy-immunotherapy arm receive four induction cycles once every 3 weeks with pembrolizumab 200 mg combined with cisplatin 75 mg/m² or carboplatin area under the curve (AUC) 5 mg/mL/min, pemetrexed 500 mg/m² for non-squamous NSCLC or carboplatin AUC 6 mg/mL/min, paclitaxel 200 mg/m² for squamous NSCLC. Recruitment is expected to end in December 2023. Clinical trial information: NCT04547504
Clinical • P3 data • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
PD-L1 expression • EGFR mutation • ALK rearrangement • ROS1 rearrangement
|
PD-L1 IHC 22C3 pharmDx
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • paclitaxel • pemetrexed
1m
Patients will be randomized 1:1 to receive either dostarlimab 500 mg IV or pembrolizumab 200 mg IV every 3 weeks (Q3W) in combination with pemetrexed 500 mg/m2 IV Q3W, and cisplatin 75 mg/m2 or carboplatin 5 mg/mL/min (investigator’s choice of CT). Exploratory endpoints include duration of response by BICR and investigator-assessed ORR per RECIST v1.1, correlation between PD-L1 expression and ORR, pharmacokinetics and immunogenicity of dostarlimab and potentially pembrolizumab, biomarkers correlated with response, and change in lung cancer symptoms, severity, and health-related quality of life. Enrollment has begun; approximately 240 patients will be enrolled from global sites.
Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
PD-L1 expression • BRAF V600E • EGFR mutation • BRAF V600 • ALK mutation
|
PD-L1 IHC 22C3 pharmDx
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • Jemperli (dostarlimab)
1m
The size of the INSIGHT biobank moreover enabled detection of low percentage events such as early stage KRAS mutations. This blood-based genomic test may help guide treatment selection and promote expedited time-to-treatment for patients with KRAS G12C/V/D+ NSCLC.
Clinical
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase)
|
KRAS mutation • KRAS G12C • KRAS G12D • KRAS G12V • KRAS G12
1m
The abstract for this presentation has not been submitted or is currently under embargo until August 18, 2021 at 16:00 MDT.
Clinical
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
Tyvyt (sintilimab) • Byvasda (bevacizumab biosimilar)
1m
Major drivers of cost-effectiveness were drug acquisition costs, LB cost and prevalence of targetable alterations. Conclusion The use of LB added to TT in the initial diagnosis of clinically selected patients with advanced NSCLC significantly increases the proportion of patients that can access targeted therapy and also reduces costs, primarily by avoiding inappropriate use of chemo-immunotherapy first-line.
Liquid biopsy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
Guardant360® CDx
1m
rwTTNTD and rwTTD reinforce effectiveness in this rw population. Further analyses are planned to determine longer-term outcomes.
Clinical • Real-world evidence
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR T790M • EGFR exon 19 deletion
|
Tagrisso (osimertinib)
1m
Pembrolizumab was the most common regimen (25.5%) with median OS of 32 months similar to the Keynote 024 trial finding (~30 months). Male KRASG12C+ more likely to present with brain metastasis at diagnosis and had poorer survival.
PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase)
|
PD-L1 expression • KRAS mutation • KRAS G12C • PD-L1 negative • KRAS G12
|
Keytruda (pembrolizumab)
1m
Conclusion The frequency of EGFR mutations was 17.3% and PD-L1 positivity was 36.7 in early-stage non-squamous NSCLC patients from Brazil. These resectable patients EGFRm or PD-L1-positive could be eligible for adjuvant tailored treatment.
PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • EGFR mutation • PD-L1 overexpression • PD-L1 negative
|
PD-L1 IHC 22C3 pharmDx • cobas® EGFR Mutation Test v2 • TruSight Tumor 15 Assay
1m
Stage III patients were treated with definitive chemoradiation in the majority of cases (16/70%) followed by consolidation durvalumab in 8 patients...Conclusion The majority of our early stage ALK+ cohort relapsed with a metastatic pattern consistent with de novo advanced ALK+ disease including brain-only relapses. Time to relapse was directly correlated with stage at initial diagnosis and shorter time to relapse was associated with poorer outcome after diagnosis of advanced disease.
Clinical • Real-world evidence
|
ALK (Anaplastic lymphoma kinase)
|
ALK positive
|
Imfinzi (durvalumab)
1m
The use of combined ALK-ROS FISH allows for excellent demonstration of ALK and ROS1 rearrangements in the same section using the same criteria validated in single gene break apart FISH probes. ROS1 protein is commonly overexpressed in ALK rearranged NSCLC and may represent cross reactivity with ALK or a related protein.
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR mutation • BRAF mutation • ALK positive • ALK rearrangement • ROS1 positive • ROS1 fusion • ROS1 rearrangement • ALK negative • ALK translocation
|
VENTANA ALK (D5F3) CDx Assay
1m
Higher levels of integrated PD-L1 data of circulating and tumor PD-L1 results significantly stratified patients according to efficacy of PD-(L1) blockade agents (PFS: HR 0.29; 95% CI: 0.16-0.54, p<0.0001; OS: HR 0.28; 95% CI: 0.14-0.54, p=0.0002), even when tumor PD-L1 expression was excluded. Table 1 Conclusion Our results suggest that the integration of circulating PD-L1+ leukocytes, PLT, PMPs and sPD-L1 and tumor PD-L1 expression could be helpful to decide the best treatment strategy in advanced NSCLC pts candidates for anti-PD-(L)1 agents.
Clinical • Clinical data • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CD14
|
PD-L1 expression
|
PD-L1 IHC 22C3 pharmDx
1m
Clinical • New P1/2 trial
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
|
PD-L1 expression
|
AZD2936
1m
Clinical • New trial • Checkpoint inhibition
|
ALK (Anaplastic lymphoma kinase)
|
ALK positive
|
Avastin (bevacizumab) • Alecensa (alectinib)
1m
Using data systematically collected in Dutch national cancer and pathology registries, the prevalence of KRAS p.(G12C) mutations in the entire population of patients with stage IV-NSCLC in the Netherlands is 15.5%. Although the testing rate increased from 2013 to 2017, there seems to be room for improvement although reasons why a test was not requested was not systematically captured.
Retrospective data
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS G12
1m
These data show significantly higher EGFR/KRAS, ALK and ROS1 testing proportions compared to 2015. Further improvement remains possible, in some laboratories more than in others, and especially for ROS-1 and RET testing, to identify candidates for targeted therapy. Initiatives for improvement will involve starting a dialogue with profes- sionals on a regional level, where these findings and recommendations of a best practice session will be discussed.
Clinical
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR mutation • BRAF mutation • HER-2 mutation • ALK rearrangement • RET mutation • RET rearrangement
1m
Clinical • New P2 trial • Combination therapy • Pan tumor
|
BRAF (B-raf proto-oncogene)
|
BRAF mutation
|
Keytruda (pembrolizumab) • carboplatin • pemetrexed • SEA-CD40
1m
Clinical • New P1 trial
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • NOUS-PEV
1m
Clinical • New P3 trial • Combination therapy
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion
|
Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Leclaza (lazertinib)
1m
P2, N=90, Not yet recruiting, Guangdong Association of Clinical Trials
Clinical • New P2 trial
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R
|
Avastin (bevacizumab) • Tagrisso (osimertinib)
2ms
Clinical • New P2 trial • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Tecentriq (atezolizumab) • Hyleukin-7 (efineptakin alfa)
2ms
Clinical • Enrollment open
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • Abraxane (albumin-bound paclitaxel) • pemetrexed
2ms
Patients with ECOG-PS 2 derived little benefit from the use of first-line pembrolizumab. In patients with liver metastases the association of pembrolizumab with platinum-based chemotherapy could be a better option than pembrolizumab alone.
Clinical • Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab)
2ms
New P2 trial
|
EGFR (Epidermal growth factor receptor) • PIAS4 (Protein Inhibitor Of Activated STAT 4)
|
EGFR mutation
|
Gilotrif (afatinib)
2ms
Interestingly, OS for patients with L858R was similar to those with uncommon, actionable variants (HR 1.31; 95% CI, 0.98-1.75; p = 0.069). Our analysis indicates that grouping exon 19 deletions and L858R into one class of 'common' EGFR mutations in a clinical trial may mask the true activity of an EGFR inhibitor towards specific mutations.
Journal
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion
2ms
In the mixed-histology network of PD-L1-high patients, expected OS was significantly longer with atezolizumab (estimated difference: 10.4 months [95% CrI: 1.9, 18.2]), pembrolizumab (7.2 [2.2, 12.3]), and cemiplimab (13.0 [4.2, 21.0]) versus chemotherapy but not with nivolumab (3.5 [-2.5, 10.6]) or nivolumab plus ipilimumab (6.7 [-0.5, 14.2]) versus chemotherapy...ORR was significantly higher with pembrolizumab and cemiplimab versus chemotherapy in the mixed-histology network, with sintilimab in the non-squamous network, and with combination regimens, including pembrolizumab or atezolizumab, in the squamous and non-squamous networks, except with atezolizumab plus carboplatin, paclitaxel, and bevacizumab. Survival and safety versus chemotherapy were generally similar across cancer immunotherapies and histology networks. These findings may support treatment decisions for patients with high PD-L1 status receiving first-line treatment for NSCLC.
Retrospective data • Review • Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Avastin (bevacizumab) • carboplatin • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • paclitaxel • Tyvyt (sintilimab) • Libtayo (cemiplimab)
2ms
P3; At the final IMpower150 OS analysis, ACP showed numerically, but not statistically significant, OS improvement vs BCP. Updated data with an additional 20 months of follow-up showed continued OS improvement with ABCP vs BCP in all patients.
Journal • Clinical
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression • PD-L1 negative • PD-L1-H
|
VENTANA PD-L1 (SP263) Assay • VENTANA PD-L1 (SP142) Assay
|
Avastin (bevacizumab) • carboplatin • Tecentriq (atezolizumab) • paclitaxel
2ms
P=N/A, N=150, Recruiting, Ohio State University Comprehensive Cancer Center | Not yet recruiting --> Recruiting
Enrollment open • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
2ms
New P2 trial • EGFR exon 20
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
|
Avastin (bevacizumab) • Tagrisso (osimertinib)
2ms
P1, N=170, Recruiting, Inhibrx, Inc. | N=90 --> 170 | Trial completion date: Dec 2021 --> Mar 2023 | Trial primary completion date: Jul 2021 --> Nov 2022
Clinical • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK rearrangement
|
Keytruda (pembrolizumab) • INBRX-105
2ms
Clinical • P3 data
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
Avastin (bevacizumab) • erlotinib
2ms
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase)
|
ALK fusion • MET mutation
2ms
Clinical • P2 data • PK/PD data
|
CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 positive
|
Cyramza (ramucirumab) • tusamitamab ravtansine (SAR408701)
2ms
New P2 trial
|
EGFR (Epidermal growth factor receptor) • CD4 (CD4 Molecule)
|
EGFR mutation • EGFR L858R • EGFR T790M • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR G719X • EGFR exon 20 mutation • EGFR exon 18 mutation
|
cisplatin • carboplatin • pemetrexed • bintrafusp alfa (M7824)
2ms
Neither group had any AEs resulting in death. Switching to alectinib might be an option for patients who do not experience disease progression with initial crizotinib therapy, and may promote better treatment compliance.
Clinical • Journal
|
ALK (Anaplastic lymphoma kinase)
|
ALK fusion
|
Xalkori (crizotinib) • Alecensa (alectinib)
2ms
Our results suggest that compared with chemotherapy, icotinib significantly improves disease-free survival and has a better tolerability profile in patients with EGFR-mutant stage II-IIIA NSCLC after complete tumour resection.
Clinical • P3 data • Journal
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
cisplatin • pemetrexed • Conmana (icotinib) • vinorelbine tartrate
2ms
P1, N=77, Active, not recruiting, Arcus Biosciences, Inc. | Recruiting --> Active, not recruiting | N=116 --> 77 | Trial completion date: Jun 2022 --> Feb 2023 | Trial primary completion date: Jun 2021 --> Jan 2023
Clinical • Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
Keytruda (pembrolizumab) • carboplatin • pemetrexed • zimberelimab (AB122) • etrumadenant (AB928)
2ms
Clinical • Enrollment change
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • MSI (Microsatellite instability) • NTRK (Neurotrophic receptor tyrosine kinase)
|
BRAF V600E • EGFR mutation • MSI-H/dMMR • BRAF V600 • ALK rearrangement • ALK fusion
|
Keytruda (pembrolizumab) • subasumstat (TAK-981)
2ms
Clinical • New P3 trial
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK fusion
|
Keytruda (pembrolizumab) • Focus V (anlotinib) • APL-502
2ms
P2, N=63, Active, not recruiting, Korea University Guro Hospital | Recruiting --> Active, not recruiting | Trial completion date: Sep 2022 --> Mar 2023 | Trial primary completion date: Sep 2022 --> Mar 2023
Clinical • Enrollment closed • Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X
|
erlotinib
2ms
This is the first study to provide further evidence of the benefits of applying icotinib in combination with bevacizumab as first-line treatment for advanced NSCLC cases harboring EGFR mutations. However, these findings need to be verified through prospective phase 3 clinical studies.
Retrospective data • Journal
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion
|
Avastin (bevacizumab) • Conmana (icotinib)
2ms
Clinical • Enrollment closed • Combination therapy
|
BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD4 (CD4 Molecule) • NTRK (Neurotrophic receptor tyrosine kinase)
|
BRAF V600E • EGFR mutation • BRAF V600 • ROS1 positive • ALK mutation
|
carboplatin • paclitaxel • pevonedistat (MLN4924)
2ms
Clinical • Trial completion date • Trial primary completion date • Real-world evidence
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
Gilotrif (afatinib)
2ms
Clinical • New P2 trial
|
ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
PD-L1 expression
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • tiragolumab (MTIG7192A)
2ms
Clinical • New P2 trial
|
ALK (Anaplastic lymphoma kinase)
|
ALK mutation
|
carboplatin • Tyvyt (sintilimab) • pemetrexed • Elunate (fruquintinib)
2ms
Clinical • New P3 trial
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • Abraxane (albumin-bound paclitaxel) • pemetrexed
2ms
Reduction of STAT3 in the tumor microenvironment using an antisense oligonucleotide reversed immunotherapy resistance in preclinical STK11 knockout models. These results suggest that STK11 mutations may hinder response to checkpoint blockade through mechanisms including suppressive myeloid cell biology, which could be reversed by STAT3-targeted therapy.
Clinical • Journal • PD(L)-1 Biomarker • IO biomarker
|
KRAS (KRAS proto-oncogene GTPase) • STK11 (Serine/threonine kinase 11) • IL6 (Interleukin 6) • STAT3 (Signal Transducer And Activator Of Transcription 3) • IL17A (Interleukin 17A)
|
KRAS mutation • STK11 mutation
|
Imfinzi (durvalumab) • tremelimumab (CP-675206)
2ms
P, N=150, Not yet recruiting, Ohio State University Comprehensive Cancer Center
New trial • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
2ms
Enrollment open
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab)
2ms
Clinical • New P2 trial
|
PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • PIAS4 (Protein Inhibitor Of Activated STAT 4)
|
PD-L1 expression • PD-L1 overexpression • ALK rearrangement • ROS1 rearrangement
|
VENTANA PD-L1 (SP263) Assay
|
Avastin (bevacizumab) • Tecentriq (atezolizumab)
2ms
Clinical • Trial primary completion date
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion
|
Tagrisso (osimertinib) • Cyramza (ramucirumab)
3ms
Clinical • Trial completion date
|
EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
|
EGFR mutation • EGFR L858R
|
Opdivo (nivolumab) • erlotinib • Tagrisso (osimertinib) • telisotuzumab vedotin (ABBV-399)
3ms
Cisplatin monotherapy may be more effective than pemetrexed monotherapy or cisplatin plus pemetrexed combination therapy against KRAS-dependent lung cancer.
Journal • Combination therapy
|
KRAS (KRAS proto-oncogene GTPase)
|
cisplatin • pemetrexed
3ms
Pembrolizumab plus pemetrexed-platinum continued to show improved efficacy outcomes compared with placebo plus pemetrexed-platinum, with manageable toxicity. These findings support first-line pembrolizumab plus pemetrexed-platinum in patients with previously untreated metastatic nonsquamous NSCLC.
Clinical • Clinical protocol • Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed
3ms
Using electronic health records data from a large demographically and geographically diverse oncology database, we present real-world progression-free survival (rwPFS) outcomes for patients with advanced non-small cell lung cancer in the United States treated with either first-line immunotherapy as monotherapy or single-agent immunotherapy combined with chemotherapy. rwPFS was estimated for patients in each treatment group using Kaplan-Meier methods; analyses were conducted separately for patients with squamous and non-squamous histology and stratified by Eastern Cooperative Oncology Group performance status, tumor programmed death ligand-1 expression, and presence of brain metastases.
Clinical • Journal • Real-world evidence • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
3ms
Survival estimates were generally lower than those reported in pivotal clinical trials. These findings indicate that there remains room for improvement of real-world survival outcomes in patients with advanced NSCLC who receive 1L I-O-based regimens and for identification of subgroups of patients not benefitting from treatment with current I-O regimens.
Clinical • Journal • Real-world evidence • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
3ms
Pts treated with combination of cisplatin, pemetrexed and binimetinib presented no unexpected toxicity. No early signal of increased antitumor activity of binimetinib added to chemotherapy was observed in our pts population.
Clinical • P1 data • Clinical Trial,Phase I • Journal
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS exon 2 mutation
|
cisplatin • Mektovi (binimetinib) • pemetrexed
3ms
OS rates in patients receiving nivolumab for previously treated advanced NSCLC in real-world clinical practice closely mirrored those in phase 3 studies, suggesting similar effectiveness of nivolumab in clinical trials and clinical practice.
Clinical • Retrospective data • Journal • Real-world evidence • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • EGFR mutation
|
Opdivo (nivolumab)
3ms
Clinical • P2 data • Clinical Trial,Phase II • Journal • Circulating tumor DNA
|
KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • STK11 (Serine/threonine kinase 11)
|
STK11 mutation
|
carboplatin • pemetrexed
3ms
The addition of binimetinib to carboplatin and pemetrexed appears to have manageable toxicity with evidence of activity in advanced non-squamous NSCLC.
P1 data • Clinical Trial,Phase I • Journal
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MAP2K1 (Mitogen-activated protein kinase kinase 1)
|
KRAS mutation • EGFR mutation • NRAS mutation
|
carboplatin • Mektovi (binimetinib) • pemetrexed
3ms
Standard (pemetrexed), and non-standard chemotherapy (temozolomide) in patients with NSCLC failed to prevent them from BM. In terms of systemic treatment there are promising results showed when durvalumab (PACIFIC study), osimertinib (FLAURA trial) or alectinib (JALEX study) was used...Promising results in terms of reducing MCD are shown when memantine is used or/and hippocampal avoidance techniques are implemented...It seems that new trials should focus on younger, fit and non-squamous histology patients and use the tests for mild cognitive disorders (MoCA, BHA) rather than screening tests for dementia (MMSE, HVLT, ADL). The main obstacle in performing new trials on PCI in NSCLC cohorts may be, however, patients' accrual, as a difficulty which occurred during latest trials.
Review • Journal
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
Tagrisso (osimertinib) • Imfinzi (durvalumab) • temozolomide • Alecensa (alectinib) • pemetrexed • memantine
3ms
P1/2, N=24, Active, not recruiting, Genocea Biosciences, Inc. | N=99 --> 24 | Trial completion date: Dec 2022 --> Mar 2022 | Trial primary completion date: Dec 2022 --> Mar 2022
Clinical • Enrollment change • Trial completion date • Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • GEN-009
3ms
PE is associated with worse immunotherapy outcomes in NSCLC treated with ICI, including in patients with ≥50 % PD-L1 tumors. Thus, in these patients, combination strategies should be explored.
Clinical • Retrospective data • Journal • Pleural effusion
|
PD-L1 (Programmed death ligand 1)
3ms
MAIC results showed a significantly better OS and PFS for pembrolizumab + chemotherapy compared with atezolizumab + chemotherapy and a significantly better PFS for pembrolizumab + chemotherapy compared with atezolizumab + chemotherapy + bevacizumab.
Clinical • Journal
|
EGFR (Epidermal growth factor receptor)
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • carboplatin • Tecentriq (atezolizumab) • Abraxane (albumin-bound paclitaxel) • pemetrexed
3ms
This study revealed the mechanisms by which pemetrexed works an anticancer drug in the treatment of NSCLC.
Journal • IO biomarker
|
EGFR (Epidermal growth factor receptor) • BCL2 (B-cell CLL/lymphoma 2) • BAX (BCL2-associated X protein) • CASP3 (Caspase 3) • CASP8 (Caspase 8) • PARP1 (Poly(ADP-Ribose) Polymerase 1) • CASP9 (Caspase 9) • FASLG (Fas ligand)
|
EGFR exon 19 deletion • BCL2 expression • BAX expression
|
pemetrexed
3ms
Clinical • Enrollment closed • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
ALK rearrangement • ROS1 rearrangement • EGFR rearrangement
|
Opdivo (nivolumab) • marrow infiltrating lymphocytes • tadalafil
3ms
Clinical • Trial completion date • Trial primary completion date • Real-world evidence
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
Gilotrif (afatinib)
3ms
Clinical • New P3 trial • Adverse events
|
EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
|
EGFR mutation • MET overexpression
|
docetaxel • telisotuzumab vedotin (ABBV-399)
3ms
Initial brain metastases are common in NSCLC patients with positive PD-L1 expression. Further studies are necessary to understand the relationship between early brain metastasis and cancer immunity.
Journal • Clinical • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • PD-L1 negative
|
VENTANA PD-L1 (SP263) Assay
3ms
Clinical • Trial completion date • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Opdivo (nivolumab) • cisplatin • carboplatin • paclitaxel • gemcitabine • pemetrexed
3ms
Clinical • Trial completion
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression • EGFR mutation • ALK translocation
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • paclitaxel • gemcitabine • pemetrexed
3ms
Clinical • New P2 trial
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • sitravatinib (MGCD516)
3ms
ALK testing in advanced NSCLC patients, non-squamous and never-smoker squamous, provides more than 3000 QALYs in Spain over a lifetime horizon. Comparing this gain in health outcomes with the incremental costs, the resulting incremental cost-effectiveness ratio reinforces that testing non-squamous and never-smoker squamous NSCLC is a cost-effective strategy in Spain.
Clinical • Journal • HEOR • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
ALK rearrangement
3ms
P2, N=999, Active, not recruiting, UNICANCER | Trial completion date: Feb 2021 --> Dec 2023
Clinical • Trial completion date • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
Lynparza (olaparib) • Imfinzi (durvalumab) • Koselugo (selumetinib) • pemetrexed • ABSK-091 • Caprelsa (vandetanib) • capivasertib (AZD5363) • Orpathys (savolitinib) • vistusertib (AZD2014) • sapitinib (AZD8931)
3ms
Clinical • Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • ALK fusion • ROS1 fusion
|
Avastin (bevacizumab) • carboplatin • Tecentriq (atezolizumab) • pemetrexed
3ms
P1/2, N=162, Recruiting, BeiGene | Trial completion date: Dec 2021 --> Sep 2023 | Trial primary completion date: Jun 2021 --> Mar 2023
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Baize’an (tislelizumab) • BGB-A425
3ms
Given the recent surge of treatment successes and advances in thoracic oncology drug discovery, reviewing available options and deciding on the best treatment for a particular patient can be overwhelming (Fig. 1). Treatment decisions between the provider and patient/family are a risk/benefit discussion that involves strong considerations of histology (nonsquamous vs.
PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
3ms
Patients in cohort A (squamous/nonsquamous) received 1 cycle (3 weeks) of carboplatin (area under the curve [AUC] 6 mg/mL/min), paclitaxel (200 mg/m2), and pembrolizumab (200 mg), followed by carboplatin (AUC 2 mg/mL/min) and paclitaxel (45 mg/m2) once weekly for 6 weeks and 2 cycles of pembrolizumab plus standard thoracic radiotherapy. Patients in cohort B (nonsquamous) received 3 cycles of cisplatin (75 mg/m2), pemetrexed (500 mg/m2), and pembrolizumab (200 mg) every 3 weeks and thoracic radiotherapy in cycles 2 and 3...Grade 3 or higher pneumonitis occurred in 9 of 112 patients (8.0%) in cohort A and 7 of 102 (6.9%) in cohort B. Grade 3 to 5 treatment-related adverse events occurred in 72 of 112 (64.3%) and 51 of 102 (50.0%) patients, respectively. The findings of this phase 2, nonrandomized, 2-cohort study suggest promising antitumor activity of pembrolizumab plus cCRT and manageable safety in patients with previously untreated, locally advanced, stage III NSCLC.
Clinical • P2 data • Journal
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • paclitaxel • pemetrexed
4ms
P2b, N=145, Active, not recruiting, ImmunityBio, Inc. | Recruiting --> Active, not recruiting | N=636 --> 145
Clinical • Enrollment closed • Enrollment change • Checkpoint inhibition
|
BRAF (B-raf proto-oncogene) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability)
|
PD-L1 expression • BRAF V600E • MSI-H/dMMR • PD-L1 overexpression • BRAF V600
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • Anktiva (inbakicept) • PD-L1.t-haNK
4ms
P2a, N=23, Recruiting, WindMIL Therapeutics | Trial completion date: Jun 2026 --> Mar 2027 | Trial primary completion date: Mar 2022 --> Aug 2022
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
ALK rearrangement • ROS1 rearrangement • EGFR rearrangement
|
Opdivo (nivolumab) • marrow infiltrating lymphocytes • tadalafil
4ms
New P1/2 trial • Checkpoint inhibition
|
PD-L1 (Programmed death ligand 1) • MAGEA3 (MAGE Family Member A3)
|
VTP-600
4ms
If the primary endpoint is achieved, pembrolizumab could be the first choice for first-line treatment in patients with nonsquamous NSCLC with PD-L1 TPS ≥ 50%.
Clinical • P3 data • Journal • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
ALK mutation
|
Keytruda (pembrolizumab) • carboplatin • pemetrexed
4ms
Clinical • Trial primary completion date
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation
|
Balversa (erdafitinib)
4ms
P3, N=450, Active, not recruiting, National Cancer Institute (NCI) | Trial primary completion date: Nov 2021 --> Oct 2026
Clinical • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • EGFR L858R • EGFR T790M • EGFR exon 19 deletion • ALK rearrangement
|
erlotinib
4ms
P3, N=1193, Recruiting, AstraZeneca | Trial completion date: Apr 2021 --> Apr 2024 | Trial primary completion date: Apr 2021 --> Apr 2024
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK fusion
|
cisplatin • carboplatin • gemcitabine • Imfinzi (durvalumab) • Abraxane (albumin-bound paclitaxel) • tremelimumab (CP-675206) • pemetrexed
4ms
Apatinib+gefitinib as first-line therapy demonstrated superior PFS in advanced EGFR-mutant NSCLC vs placebo+gefitinib. Combination therapy brought more adverse events but did not interfere QoL.
Clinical • P3 data • Journal
|
EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53) • KDR (Kinase insert domain receptor)
|
TP53 mutation • EGFR mutation • EGFR L858R • EGFR exon 19 deletion
|
gefitinib • AiTan (rivoceranib)
4ms
PPARγ improves pemetrexed therapeutic efficacy in non-squamous NSCLC. The cytotoxicity effect of PMX can be synergized by activating PPARγ and thereby inhibiting NF-κB pathway.
Clinical • Journal
|
MYC (V-myc avian myelocytomatosis viral oncogene homolog)
|
pemetrexed
4ms
Computer-assisted analysis can improve the accuracy of TCC estimates prior to molecular diagnostic workflows. In addition, we provide a free web application to support self-training and quality improvement initiatives at other institutions.
Journal
|
NKX2-1 (NK2 Homeobox 1)
4ms
P1, N=15, Active, not recruiting, University of California, Davis | Recruiting --> Active, not recruiting | N=42 --> 15
Clinical • Enrollment closed • Enrollment change
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
KRAS mutation • EGFR mutation • ALK rearrangement • ROS1 rearrangement
|
Keytruda (pembrolizumab) • Mekinist (trametinib)
4ms
P2, N=100, Recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2022 --> Mar 2024 | Trial primary completion date: Mar 2022 --> Apr 2023
Clinical • Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • MSLN (Mesothelin)
|
KRAS mutation • EGFR mutation • ALK rearrangement • MSLN expression
|
Keytruda (pembrolizumab) • LMB-100
4ms
Clinical • Enrollment closed • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
Keytruda (pembrolizumab) • Lynparza (olaparib) • cisplatin • carboplatin • pemetrexed
4ms
This meta-analysis demonstrated that NSCLC patients with BM have more aggressive clinical features.
Retrospective data • Journal
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • CEACAM5 (CEA Cell Adhesion Molecule 5) • KRT19 (Keratin 19)
|
KRAS mutation • EGFR mutation
4ms
P1, N=290, Recruiting, Merck Sharp & Dohme Corp. | Trial completion date: Jul 2023 --> Nov 2024 | Trial primary completion date: Jul 2023 --> Nov 2024
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • paclitaxel • lenvatinib • pemetrexed • MK-4830
4ms
P2, N=100, Recruiting, National Cancer Institute (NCI) | Trial primary completion date: Apr 2021 --> Mar 2022
Clinical • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • MSLN (Mesothelin)
|
KRAS mutation • EGFR mutation • ALK rearrangement • MSLN expression
|
Keytruda (pembrolizumab) • LMB-100
4ms
P1b, N=120, Recruiting, Mersana Therapeutics | Trial completion date: Dec 2021 --> Jun 2023 | Trial primary completion date: Mar 2021 --> Dec 2022
Clinical • Trial completion date • Trial primary completion date
|
SLC34A2 (Solute carrier family 34 member 2)
|
XMT-1592
4ms
The population risk of EGFR mutation-positive NSCLC was significantly higher for Māori and Pacifica compared with New Zealand Europeans.
Clinical • Journal
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
4ms
P3, N=334, Active, not recruiting, BeiGene | Trial completion date: Sep 2020 --> Oct 2021 | Trial primary completion date: Jun 2020 --> Jul 2021
Clinical • Trial completion date • Trial primary completion date • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
cisplatin • carboplatin • pemetrexed • Baize’an (tislelizumab)
4ms
P2, N=65, Not yet recruiting, Mario Negri Institute for Pharmacological Research | Trial completion date: Apr 2025 --> Jun 2026 | Trial primary completion date: Apr 2025 --> Jun 2026
Trial completion date • Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
cisplatin • carboplatin • Imfinzi (durvalumab) • pemetrexed • vinorelbine tartrate
4ms
Clinical • New P2/3 trial
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion
|
erlotinib • gefitinib
5ms
P=N/A; Active, not recruiting --> Completed
Trial completion
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
BRAF V600E • EGFR mutation • ALK fusion • ROS1 fusion
|
Guardant360® CDx
5ms
Gene set enrichment analysis revealed that gene sets regarding activated immune responses were enriched in MGA-mutated tumors. Our work provides evidence that MGA mutation can be used as a novel predictive biomarker for ICI response in non-squamous NSCLC and merits further clinical and preclinical validation.
Journal • Tumor Mutational Burden • IO biomarker
|
PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden)
|
TMB-H
5ms
Median OS was 20.6, 16.3, 13.2, and 13.7 months for patient cohorts with PD-L1 TPS ≥ 50%, 1-49%, < 1%, and unknown, respectively. These findings demonstrate the effectiveness of pembrolizumab plus pemetrexed-carboplatin by describing clinical outcomes among patients with metastatic nonsquamous NSCLC who were treated at US oncology practices.
Clinical • Journal • Real-world evidence
|
EGFR (Epidermal growth factor receptor)
|
EGFR negative
|
Keytruda (pembrolizumab) • carboplatin • pemetrexed
5ms
The combination of docetaxel and antiangiogenic drug (ramucirumab/nintedanib) has demonstrated antitumor activity as second-line therapy in advanced NSCLC . This combination of anlotinib and docetaxel showed clinical benefit in EGFR-negative NSCLC patients in terms of PFS, ORR, and with manageable safety profile . It is a viable option for relapsed NSCLC, who has been assessed progression on first-line platinum-base chemotherapy combined with/without Immune checkpoint inhibitors, or who can’t tolerate Immunotherapy.
Clinical • P2 data
|
EGFR (Epidermal growth factor receptor) • KIT (KIT proto-oncogene, receptor tyrosine kinase) • FGFR (Fibroblast Growth Factor Receptor)
|
EGFR negative
|
docetaxel • Focus V (anlotinib) • Cyramza (ramucirumab) • nintedanib
5ms
Our findings suggest that circulating miR-34a may serve as a potential predictive biomarker in NSCLC patients treated with immunotherapy . These observations need to be further validated in a larger cohort of patients.
Clinical • IO biomarker
|
MIR155 (MicroRNA 155) • MIR200B (MicroRNA 200b) • MIR34A (MicroRNA 34a-5p) • MIR146A (MicroRNA 146a) • MIR223 (MicroRNA 223)
|
miR-34a expression
5ms
Based on this retrospective review, up to 60% of patients with early-stage NSCLC with non-squamous histology have no available EGFR testing in the pre-ADAURA era . Of the anticipated 20% of patients with expected EGFR mutations based on historical controls, we have only identified half of patients that would have been eligible for adjuvant osimertinib . This study establishes the importance of upfront EGFR mutation testing in all NSCLC patients, not only to prognosticate, but also to identify the subset of patients who could benefit from adjuvant EGFR therapy.
Clinical
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion
|
Tagrisso (osimertinib)
5ms
Compared to gefitinib monotherapy, gefitinib combined with bevacizumab in the treatment of non-squamous NSCLC with EGFR L858R showed similar efficacy and safety profiles.
Clinical
|
EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53) • DNMT3A (DNA methyltransferase 1) • TET2 (Tet Methylcytosine Dioxygenase 2)
|
TP53 mutation • EGFR mutation • EGFR L858R • DNMT3A mutation • TET2 mutation
|
Avastin (bevacizumab) • gefitinib
5ms
P2, N=21, Active, not recruiting, Washington University School of Medicine | Recruiting --> Active, not recruiting
Enrollment closed • Checkpoint inhibition
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK mutation
|
Tecentriq (atezolizumab) • Cyramza (ramucirumab)
5ms
Efti in combination with pembrolizumab is safe and shows encouraging antitumor activity in 1st line advanced NSCLC patients across all PD-L1 (TPS) levels.
Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • eftilagimod alpha (IMP 321)
5ms
Median treatment duration for pts treated with CarboPem (n = 19), CisplatinPem (n = 16) and CarboTaxol (n = 6) were 4.7 (q1-q3: 2.6-6.6), 7.4 (q1-q3: 5.0-12.8) and 3.3 (q1-q3: 2.8-3.8) months, respectively . For afatinib (n = 3), erlotinib (n = 2) and gefitinib (n = 1), median treatment durations were 1.6 (q1-q3: 0.5-2.8); 1.8 (q1-q3: 1.4-2.1) and 2.3 months, respectively... This large, national real-world analysis based on medical chart data’s confirm that EGFR 20ins is a rare disease (0.4% of advanced nsqNSCLC) . Currently available EGFR TKIs appear to have low efficacy and response to chemotherapy seems identical to that of EGFR wild-type/not tested pts . Prognosis for NSCLC pts with EGFR 20ins mutations was in line with that of EGFR wild type/not tested but worse than common EGFR mutations highlighting the need for advancements for this rare population.
Clinical • Real-world evidence • PD(L)-1 Biomarker • IO biomarker • EGFR exon 20
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
|
cisplatin • erlotinib • Gilotrif (afatinib) • gefitinib
5ms
Clinical Trial Registry Number: NCT04579380 Funding: Seagen Inc Background: Tucatinib (TUC) is a highly selective HER2-directed TKI approved in combination with trastuzumab (Tras) and capecitabine (Cape) for HER2 overexpressed/amplified (HER2+) metastatic breast cancer (BC), based on a statistically significant and clinically meaningful PFS, OS, and ORR benefit over Tras and Cape...Metastatic cervical cancer: must have received platinum-based chemotherapy ± bevacizumab; hormone receptor positive (HR+) HER2-mut BC: must have received a prior CDK4/6 inhibitor...HR+ BC pts will also receive fulvestrant 500 mg IM every 4 weeks and C1 D15...Sites are open in the US; EU and Asia will be opened . Enrollment began in Dec 2020.
P2 data • Pan tumor
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 amplification • HER-2 overexpression
|
Herceptin (trastuzumab) • Avastin (bevacizumab) • capecitabine • fulvestrant • Tukysa (tucatinib)
5ms
Patients with asymptomatic brain metastases were admitted.Eligible patients were given gefitinib (250 mg QD) or icotinib (125 mg TID) in combination with anlotinib (10 mg per day, on days 1‒14; 21 days per cycle) until disease progression . The combination of the first-generation EGFR-TKIs and anlotinib shows impressive ORR and DCR, and acceptable toxicity in treatment-naïve advanced NSCLC patients with activating EGFR mutations, and we observed a high proportion of patients harboring de novo EGFR T790M mutations in this study.
Clinical • P2 data
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR T790M • EGFR exon 19 deletion
|
gefitinib • Focus V (anlotinib) • Conmana (icotinib)
5ms
The triplet trastuzumab, pertuzumab and docetaxel is feasible and active in HER2 pretreated advanced NSCLC . These results confirm the activity of HER2 antibodies-based strategy which should be considered in these patients.
Clinical • PD(L)-1 Biomarker • IO biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • HER-2 mutation • HER-2 exon 20 insertion • HER-2 exon 20 mutation
|
Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab)
5ms
1L cemiplimab monotherapy improved OS, PFS, and ORR vs chemotherapy, in patients with advanced NSCLC with PD-L1 ≥50%, and clinically stable brain metastases at baseline . Cemiplimab monotherapy represents a suitable option for this subgroup of patients.
Clinical
|
PD-L1 (Programmed death ligand 1)
|
Libtayo (cemiplimab)
5ms
S1900A failed to show the requisite level of efficacy for rucaparib in advanced NSCLC pts with high genomic LOH and/or a BRCA1/2 mutation . There were no new safety signals and hematologic toxicities were the most frequent adverse events . Genomic LOH as a phenotypic marker of HRD does not predict sufficient activity of rucaparib in NSCLC .
Clinical • P2 data • BRCA Biomarker • PARP Biomarker
|
BRCA2 (Breast cancer 2, early onset) • BRCA1 (Breast cancer 1, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
|
BRCA1 mutation • BRCA2 mutation • HRD • HRD + BRCA1 mutation • BRCA mutation
|
Rubraca (rucaparib)
5ms
P2, N=50, Recruiting, National Hospital Organization Nagoya Medical Center | Trial completion date: Oct 2023 --> Nov 2024 | Trial primary completion date: May 2022 --> May 2023
Clinical • Trial completion date • Trial primary completion date • Tumor proportion score
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK mutation • ALK translocation
|
Keytruda (pembrolizumab) • pemetrexed
5ms
Treatment-related pneumonitis occurred at a higher rate in the real-world population than that reported previously; it led to worse survival outcomes. Pneumonitis requires more attention. Additional studies are required to improve the safety of this combination therapy.
Retrospective data • Journal
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
|
Keytruda (pembrolizumab) • pemetrexed
5ms
Biomarker testing remains underutilized in NSCLC. Future work should include larger populations and evaluate hospital-specific testing protocols to identify and address barriers to guideline-recommended testing.
Clinical • Journal • PD(L)-1 Biomarker • IO biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
5ms
P3, N=1224, Active, not recruiting, EMD Serono Research & Development Institute, Inc. | Trial primary completion date: Apr 2021 --> Oct 2021
Clinical • Trial primary completion date • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
cisplatin • carboplatin • paclitaxel • gemcitabine • Bavencio (avelumab) • pemetrexed
5ms
Trial initiation date
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab)
5ms
Trial completion date • Clinical
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
VENTANA PD-L1 (SP263) Assay
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • paclitaxel • gemcitabine • pemetrexed
5ms
P1b, N=230, Recruiting, Merck Sharp & Dohme Corp. | Trial completion date: Aug 2022 --> Jun 2024 | Trial primary completion date: Aug 2022 --> Jun 2024
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • MGMT (6-O-methylguanine-DNA methyltransferase)
|
Keytruda (pembrolizumab) • carboplatin • gemcitabine • Abraxane (albumin-bound paclitaxel) • pemetrexed • MK-0482
5ms
Trial completion date • Clinical
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
Guardant360® CDx
5ms
P1, N=492, Recruiting, Merck Sharp & Dohme Corp. | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • etoposide IV • pemetrexed • vibostolimab (MK-7684) • vibostolimab/pembrolizumab (MK-7684A)
5ms
P1, N=22, Recruiting, Chao Huang | Trial completion date: Aug 2020 --> Aug 2023 | Trial primary completion date: Apr 2020 --> Apr 2022
Trial completion date • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • EGFR T790M
|
sirolimus • epacadostat (INCB024360)
5ms
P2, N=90, Active, not recruiting, Alliance Foundation Trials, LLC. | Trial completion date: Sep 2021 --> Dec 2021 | Trial primary completion date: Mar 2021 --> Sep 2021
Clinical • Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK translocation
|
Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed
5ms
P1/2, N=313, Active, not recruiting, Sanofi | Trial completion date: Apr 2021 --> Sep 2021 | Trial primary completion date: Apr 2021 --> Sep 2021
Clinical • Trial completion date • Trial primary completion date
|
CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 positive • CEACAM5 expression
|
tusamitamab ravtansine (SAR408701)
5ms
Clinical • Enrollment change • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
cisplatin • carboplatin • capecitabine • etoposide IV • oxaliplatin • Abraxane (albumin-bound paclitaxel) • pemetrexed • Baize’an (tislelizumab) • ociperlimab (BGB-A1217)
5ms
P=N/A, N=154, Active, not recruiting, iOMEDICO AG | Recruiting --> Active, not recruiting | N=822 --> 154 | Trial completion date: Jul 2025 --> Jul 2021 | Trial primary completion date: Jul 2025 --> Jul 2021
Clinical • Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Tecentriq (atezolizumab)
5ms
Erlotinib, gefitinib, afatinib and icotinib are all active agents in EGFR M+ NSCLC patients, and demonstrate an increased tumour response rate and prolonged PFS compared to cytotoxic chemotherapy. We found a beneficial effect of the TKI compared to cytotoxic chemotherapy in adverse effect and health-related quality of life. We found limited evidence for increased OS for the TKI when compared with standard chemotherapy, but the majority of the included trials allowed participants to switch treatments on disease progression, which will have a confounding effect on any OS analysis. Single agent-TKI remains the standard of care and the benefit of combining a TKI and chemotherapy remains uncertain as the evidence is based on small patient numbers. Cytotoxic chemotherapy is less effective in EGFR M+ NSCLC than erlotinib, gefitinib, afatinib or icotinib and is associated with greater toxicity. There are no data supporting the use of monoclonal antibody therapy. Icotinib is not available outside China.
Clinical • Review • Journal
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
Erbitux (cetuximab) • erlotinib • Gilotrif (afatinib) • gefitinib • carboplatin • paclitaxel • pemetrexed • Conmana (icotinib)
5ms
Clinical • Enrollment change
|
EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
|
EGFR mutation • MET expression
|
telisotuzumab vedotin (ABBV-399)
5ms
P2, N=40, Not yet recruiting, The First Affiliated Hospital with Nanjing Medical University
Clinical • New P2 trial
|
ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
ALK mutation • ROS1 mutation
|
cisplatin • carboplatin • Focus V (anlotinib) • Abraxane (albumin-bound paclitaxel) • Tyvyt (sintilimab) • pemetrexed
5ms
P2, N=50, Recruiting, Shirish M Gadgeel | Not yet recruiting --> Recruiting | Initiation date: Jan 2021 --> Apr 2021
Clinical • Enrollment open • Trial initiation date • IO biomarker
|
PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase)
|
PD-L1 expression • KRAS mutation
|
carboplatin • Imfinzi (durvalumab) • pemetrexed
5ms
Those with ≥1 result prior and received recommended therapy had a longer median PFS and lower risk of progression. This study supports the current guidelines recommending molecular profiling at diagnosis.
Clinical • Real-world evidence
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
|
ALK positive
5ms
Prevalence of METex14 were heterogeneous by histology (non-squamous carcinoma, 0.8%–10.8%; sarcomatoid, 4.9%–25.0%; squamous cell carcinoma data was limited), however, assay type, number of patients screened, study setting (single or multiple institutions) and whether patients where routinely screened for METex14 may impact the reported prevalence. CONCLUSIONS This systematic review provides the first overview of the regional epidemiology of METex14 skipping and highlights the rarity of this alteration in NSCLC.
Clinical • Review
|
MET (MET proto-oncogene, receptor tyrosine kinase)
|
MET exon 14 mutation
5ms
Enrollment open
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
|
ROS1 fusion • NTRK fusion
|
LiquidHALLMARK®
5ms
Advancement in treatment of lung cancer is accompanied by an increasing number of tests that should be run to determine potential therapy options for each patient. We assessed adoption of testing recommendations for ALK rearrangements in a national database. While test utilization increased over the time period studied (2012-2019), there is still room for improvement. Efforts are needed to increase test utilization in under-tested groups, thus enabling eligible patients to benefit from novel lung cancer therapies.
Clinical • Journal
|
ALK (Anaplastic lymphoma kinase)
|
ALK rearrangement
5ms
Clinical • New P2 trial
|
PD-L1 (Programmed death ligand 1)
|
cisplatin • carboplatin • Tecentriq (atezolizumab) • paclitaxel • gemcitabine • pemetrexed • tiragolumab (MTIG7192A)
5ms
New P2 trial
|
NTRK (Neurotrophic receptor tyrosine kinase)
|
ROS1 fusion • NTRK fusion
|
Rozlytrek (entrectinib)
6ms
Clinical • Trial completion • Combination therapy
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1) • CYP1A2 (Cytochrome P450, family 1, subfamily A, polypeptide 2) • UGT1A9 (UDP Glucuronosyltransferase Family 1 Member A9)
|
KRAS mutation • ALK rearrangement • UGT1A1*1*1
|
carboplatin • Mektovi (binimetinib) • pemetrexed
6ms
Real world data suggest that receipt of treatment that is guided by biomarker testing results is associated with improved survival outcomes in this patient population.
Retrospective data
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
6ms
TTT appeared to be influenced by patient demographics and the clinical course of disease. Better health care access in urban areas and a more accelerated course of disease (i.e., brain metastases) may reduce the TTT. Further research is needed to characterize the influence of patient and clinical factors on TTT and to understand the effect of TTT on patient outcomes.
Clinical • Reimbursement • Medicare
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
6ms
Selpercatinib (LOXO-292) and pralsetinib (BLU-667) are potent and selective inhibitors that target RET alterations, including fusions and mutations, irrespective of the tissue of origin. As has been observed with other TKIs, the emergence of acquired resistance may limit long-term efficacy of these agents. Therefore, understanding the mechanisms of resistance is necessary for the development of strategies to overcome them.
Review • Journal • IO biomarker
|
RET (Ret Proto-Oncogene)
|
RET fusion • RET positive
|
Retevmo (selpercatinib) • Gavreto (pralsetinib)
6ms
Clinical • Enrollment closed • Combination therapy
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • EML4 (EMAP Like 4)
|
EGFR mutation • EML4-ALK fusion • ALK fusion • ROS1 fusion • ALK mutation • ROS1 mutation
|
cisplatin • carboplatin • Imfinzi (durvalumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • pemetrexed
6ms
P2, N=16, Active, not recruiting, Wake Forest University Health Sciences | Trial completion date: Feb 2021 --> Jul 2021
Clinical • Trial completion date
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
ROS1 mutation
|
pemetrexed
6ms
P1, N=8, Active, not recruiting, Sichuan University | Recruiting --> Active, not recruiting | N=18 --> 8 | Trial completion date: Dec 2020 --> Jun 2021
Clinical • Enrollment closed • Enrollment change • Trial completion date
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR negative
|
cisplatin • carboplatin • Focus V (anlotinib) • pemetrexed
6ms
Clinical • Journal • HEOR • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • PD-L1 overexpression
|
Keytruda (pembrolizumab)
6ms
Clinical • Enrollment change • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • MGMT (6-O-methylguanine-DNA methyltransferase)
|
Keytruda (pembrolizumab) • carboplatin • gemcitabine • Abraxane (albumin-bound paclitaxel) • pemetrexed • MK-0482
6ms
P2, N=48, Recruiting, Swiss Group for Clinical Cancer Research | Trial primary completion date: Apr 2021 --> Apr 2022
Clinical • Trial primary completion date
|
PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
PD-L1 expression • ALK rearrangement • ALK fusion
|
Imfinzi (durvalumab)
6ms
The primary endpoint was met at the interim analysis, showing a statistically significant and clinically meaningful improvement in progression-free survival with camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone in all patients, supporting camrelizumab plus carboplatin and pemetrexed as a first-line treatment option for Chinese patients with advanced non-squamous NSCLC without EGFR and ALK alterations. The trial is being continued to collect long-term outcomes in all patients and carry out confirmatory statistical testing for progression-free survival in the PD-L1-positive population.
Clinical • P3 data • Journal
|
PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression
|
carboplatin • AiRuiKa (camrelizumab) • pemetrexed
6ms
Clinical • Enrollment closed • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK fusion
|
carboplatin • Tecentriq (atezolizumab) • pemetrexed
6ms
P3, N=406, Recruiting, Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting --> Recruiting
Clinical • Enrollment open
|
PD-L1 (Programmed death ligand 1)
|
cisplatin • carboplatin • paclitaxel • docetaxel • Tuoyi (toripalimab) • pemetrexed
6ms
P2, N=5, Terminated, Jiangsu HengRui Medicine Co., Ltd. | N=50 --> 5 | Not yet recruiting --> Terminated; changes in the R&D strategy
Clinical • Enrollment change • Trial termination • Combination therapy
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
AiRuiKa (camrelizumab) • BP102 (bevacizumab biosimilar)
6ms
P2, N=35, Active, not recruiting, Greg Durm, MD | Trial primary completion date: Feb 2021 --> Aug 2021
Clinical • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR mutation • ALK rearrangement
|
Keytruda (pembrolizumab) • docetaxel
6ms
P2, N=25, Active, not recruiting, Joel Neal | Recruiting --> Active, not recruiting
Clinical • Enrollment closed • Circulating tumor DNA
|
PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression • EGFR mutation • ALK rearrangement
|
Keytruda (pembrolizumab)
6ms
P2, N=170, Active, not recruiting, Daiichi Sankyo, Inc. | Trial primary completion date: Feb 2021 --> Jun 2021 | Trial completion date: Aug 2021 --> Dec 2021
Clinical • Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 overexpression • HER-2 mutation
|
Enhertu (fam-trastuzumab deruxtecan-nxki)
6ms
P3, N=560, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Recruiting
Clinical • Enrollment open • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK rearrangement
|
carboplatin • AiRuiKa (camrelizumab) • pemetrexed • famitinib (SHR 1020)
6ms
Six patients were treated with concomitant chemotherapy (pembrolizumab with carboplatin and pemetrexed). In a small, heterogeneous cohort of advanced NSCLC patients treated with ICIs, we demonstrate that elevated baseline levels of acute-phase reactants (CRP and IL-6) potentially act as an indirect surrogate for high plasma A2aR levels. Validation from larger studies is required to understand the biomarker implications of these findings in determining outcomes to ICIs.J.D.M. and A.R.N contributed equally to this work.
Clinical • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
|
IL6 (Interleukin 6) • CD73 (5'-Nucleotidase Ecto) • ENTPD1 (Ectonucleoside Triphosphate Diphosphohydrolase 1) • CRP (C-reactive protein)
|
Keytruda (pembrolizumab) • carboplatin • pemetrexed
6ms
STK11/LKB1 and/or KEAP1 genomic alterations are found in ~25% of non-squamous non-small cell lung cancer and have been reported as a major predictor of primary resistance to PD-1 blockade. Together, these data demonstrate that high-throughput in vivo genetic screens can identify tumor cell-intrinsic drivers of immune evasion and establish murine system relevant to the study of primary resistance to PD-1 axis immunotherapy and more generally, tumor cell-intrinsic immune evasion.
Preclinical • PD(L)-1 Biomarker • IO biomarker
|
STK11 (Serine/threonine kinase 11) • KEAP1 (Kelch Like ECH Associated Protein 1) • CD47 (CD47 Molecule) • ADAR (Adenosine Deaminase RNA Specific)
|
Undisclosed immune evasion therapeutic
6ms
QL1101 showed similar efficacy and safety profiles as compared to bevacizumab among Chinese patients with untreated locally advanced non-squamous NSCLC.
Clinical • P3 data • Journal
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
carboplatin • paclitaxel • Ankada (bevacizumab biosimilar)
6ms
These results demonstrate enrichment of immune activation gene expression pathways and paradoxically, increased expression of immune checkpoint biomarkers in stage III tumors relative to stage IV tumors, suggesting that evolution of metastasis in NSCLC tumors is accompanied by consequential changes in the tumor-immune microenvironment. This comprehensive assessment of the expression of immune checkpoint genes, and the transcriptome more broadly, may help to inform the development of anti-cancer immune modulating agents or use of existing ICB in early-stage NSCLC.
Clinical • Checkpoint inhibition • Real-world evidence • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • IL17A (Interleukin 17A) • CD4 (CD4 Molecule)
|
PD-L1 expression
6ms
Patients in the oncogene-driven adenosquamous/squamous group had significantly higher response rates as compared to the historical squamous cell group and no significant difference in response rates as compared to the historical adenocarcinoma comparison group. In summary, contrary to prior studies, this case series does suggest that pemetrexed may be a viable treatment option in patients with squamous cell histology who also have a targetable mutation.
Clinical
|
ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
RET fusion • ROS1 fusion
|
pemetrexed
6ms
Integrative multi-omic analysis suggests preserved anti-tumor immune surveillance in patients who are disease-free after 2 years from surgical resection with curative intent for treatment of NSCLC relative to patients with disease recurrence. Further analysis is ongoing to interrogate genomic and immune variables that are associated with disease recurrence.
PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • CD68 (CD68 Molecule) • ICOS (Inducible T Cell Costimulator)
6ms
NEO-PV-01 in combination with pembrolizumab and carboplatin/pemetrexed has a good safety profile and induces de novo immune responses in first-line non-squamous NSCLC. The association of baseline disease characteristics to prolonged PFS suggests future patient enrichment strategies for evaluation of this novel regimen in a phase 2 trial.
Clinical • Clinical data • Combination therapy • PD(L)-1 Biomarker
|
CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • CD4 (CD4 Molecule)
|
Keytruda (pembrolizumab) • carboplatin • pemetrexed • Neo Vax (NEO-PV-01)
6ms
ORR in non-squamous EGFR WT NSCLC was encouraging with a tolerable safety profile, and this cohort met prespecified criteria to transition to stage 2. In this cohort, ORR was highest in the c-Met high group, though also clinically meaningful in the intermediate group. Enrollment into the squamous cohort was stopped.
Clinical • IO biomarker
|
EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
|
EGFR mutation • MET mutation • MET expression • MET-H
|
telisotuzumab vedotin (ABBV-399)
6ms
Mutation of T790M in non-squamous NSCLC prospects worse survival than other EGFR mutations, while mutation of non-L858R and non-T790M subtypes was not a worse factor than EGFR wide-type group. The heterogeneity of EGFR alternations may be beneficial for establishing the uses of PD-(L)1 therapies for lung cancers.
PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR T790M
|
MSK-IMPACT
6ms
Anti-PD-1(αPD-1) combined with paclitaxel(Pac) / carboplatin(Carbo) and pemetrexed(Pem) / cisplatin(Cis) are standard therapy in non-squamous and squamous lung cancer patients, respectively. Incorporation of SKI-G-801, a novel AXL inhibitor, with αPD-1 combined with chemotherapy significantly improved overall survival and anti-tumor activity in both non-squamous and squamous lung cancer model through enhancing cytotoxicity of CD8+ T cells and memory CD4+ T cells. These findings provide mechanistic insight into the activity of SKI-G-801 combined with standard therapy and support its clinical development in metastatic NSCLC as first line therapy.
CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CD44
|
cisplatin • carboplatin • paclitaxel • pemetrexed • SKI-G-801
6ms
In this study, we aimed to investigate the clinical and molecular factors that affect the efficacy of first-generation EGFR-TKI regimen with or without bevacizumab as first-line treatment of patients with EGFR-mutant NSCLC. A total of 176 patients with EGFR-mutant stage IIIB-IV relapsed or metastatic NSCLC and received first-generation EGFR-TKI gefitinib or erlotinib monotherapy (T; n=88) or combined with bevacizumab (A+T; n=88) were included in our study. Our study demonstrated the clinical value of the nomogram model in predicting the subset of patients who benefits from first-generation EGFR-TKI regimen with or without bevacizumab.
EGFR (Epidermal growth factor receptor) • CDK4 (Cyclin-dependent kinase 4) • FGF3 (Fibroblast growth factor 3)
|
TP53 mutation • EGFR mutation • EGFR L858R • EGFR T790M • EGFR exon 19 deletion • EGFR amplification • CDK4 mutation
|
Avastin (bevacizumab) • erlotinib • gefitinib
6ms
Clinical • New P2 trial • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
zimberelimab (AB122) • domvanalimab (AB154) • etrumadenant (AB928)
6ms
P2, N=301, Active, not recruiting, Canadian Cancer Trials Group | Trial completion date: Dec 2020 --> Dec 2021
Clinical • Trial completion date
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • NKX2-1 (NK2 Homeobox 1) • TP63 (Tumor protein 63)
|
EGFR mutation • ALK fusion
|
Imfinzi (durvalumab) • tremelimumab (CP-675206)
6ms
Different assays and NGS platforms can achieve differing results. Each assay's limitations need to be considered to ensure the quality of precision medicine in clinical practice.
Journal • Next-generation sequencing
|
ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
ROS1 fusion • ROS1 rearrangement
|
Xalkori (crizotinib)
6ms
Clinical • New P3 trial • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
cisplatin • carboplatin • pemetrexed • dexamethasone • cosibelimab (CK-301)
6ms
Clinical • New P2 trial
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
|
EGFR mutation • HER-2 amplification • EGFR L858R • EGFR T790M • HER-2 mutation
|
Irene (pyrotinib) • Ameile (almonertinib)
6ms
The prevalence of MET exon 14 skipping in a North American population was 2.1 %. Unlike other targetable mutations, patients were older and more commonly current or former smokers. Patients with MET exon 14 skipping alteration demonstrate disease control with crizotinib, platinum-based chemotherapy and immunotherapy. Co-mutations with TP53 were commonly noted, but correlation between co-mutations and efficacy of therapy were not identified in this cohort.
Journal • IO biomarker
|
TP53 (Tumor protein P53) • MET (MET proto-oncogene, receptor tyrosine kinase)
|
TP53 mutation • MET exon 14 mutation
|
Xalkori (crizotinib)
7ms
P2, N=25, Recruiting, National Cancer Institute (NCI) | Trial completion date: Feb 2021 --> Feb 2022 | Trial primary completion date: Feb 2021 --> Feb 2022
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD4 (CD4 Molecule) • NTRK (Neurotrophic receptor tyrosine kinase)
|
BRAF V600E • EGFR mutation • BRAF V600 • ROS1 positive • ALK mutation
|
carboplatin • paclitaxel • pevonedistat (MLN4924)
7ms
Clinical • Enrollment closed
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • lenvatinib • pemetrexed
7ms
Compared with wild type, non-squamous NSCLC patients with STK11/KEAP1 mutations may not benefit more from both atezolizumab and docetaxel. However, patients with mere KEAP1 mutations and without STK11 mutations may have a better response to atezolizumab than docetaxel.
Clinical • Journal • Tumor Mutational Burden • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • STK11 (Serine/threonine kinase 11) • KEAP1 (Kelch Like ECH Associated Protein 1)
|
PD-L1 expression • EGFR mutation • STK11 mutation • KEAP1 mutation
|
Tecentriq (atezolizumab) • docetaxel
7ms
Background: The standard therapy for advanced stage non-small cell lung cancer (NSCLC) with no actionable gene alterations is a platinum-based chemotherapy doublet and immune checkpoint blocker (ICB), either concurrently or sequentially, followed by docetaxel at the time of tumor progression. Clinical Trial Registration: ClinicalTrials.gov registration (NCT02250326). EudraCT number: 2014-001105-41.
Clinical • Journal • PD(L)-1 Biomarker
|
ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK translocation
|
Imfinzi (durvalumab) • docetaxel • Abraxane (albumin-bound paclitaxel)
7ms
Clinical • Enrollment change • Combination therapy
|
CEACAM5 (CEA Cell Adhesion Molecule 5)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • tusamitamab ravtansine (SAR408701)
7ms
In the JAVELIN Lung 200 trial, avelumab showed clinical activity as second-line treatment for patients with advanced NSCLC. Post hoc analyses suggest that the primary OS analysis may have been confounded by subsequent ICI use in the docetaxel arm. ClinicalTrials.gov identifier: NCT02395172.
Clinical • Retrospective data • Journal • Checkpoint inhibition
|
PD-L1 (Programmed death ligand 1)
|
docetaxel • Bavencio (avelumab)
7ms
Clinical • Trial primary completion date
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation
|
Balversa (erdafitinib)
7ms
Clinical • P1 data • Combination therapy • PD(L)-1 Biomarker
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 overexpression
|
Imfinzi (durvalumab) • Enhertu (fam-trastuzumab deruxtecan-nxki)
7ms
A trend to worse OS was observed in pts with bone metastasis. No differences in OS were observed according to the type of tumor sample (cytological and histological samples).Conclusions Preliminary results showed that smoking and overweight could be potential predictive factors of better outcome withe bone metastasis potential predictive factors of poor outcome, and no differences in survival were observed according to the type of tumor sample
Clinical • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • PD-L1 overexpression
7ms
P1, N=216, Active, not recruiting, Daiichi Sankyo, Inc. | Recruiting --> Active, not recruiting
Clinical • Enrollment closed
|
ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR L858R • EGFR exon 19 deletion • ALK fusion • EGFR L861Q • ROS1 fusion • EGFR G719X • ALK-ROS1 fusion
|
patritumab deruxtecan (U3-1402)
7ms
P1, N=48, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting
Clinical • Enrollment closed
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • EGFR mutation + ALK mutation
|
carboplatin • Abraxane (albumin-bound paclitaxel) • pemetrexed • Esbriet (pirfenidone)
7ms
New P2 trial
|
PD-L1 (Programmed death ligand 1)
|
cisplatin • carboplatin • Imfinzi (durvalumab) • pemetrexed • vinorelbine tartrate
7ms
This therapeutic regimen was well tolerated and could be a promising strategy for these patients. Serum VEGF could be a potential biomarker to predict a subset of patients who are likely to benefit from EGFR-TKIs combined with bevacizumab.
Clinical • Journal
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
Avastin (bevacizumab)
7ms
This assay detected alterations in other therapeutically relevant genes at a rate similar to tissue analysis. These results demonstrate the analytical and clinical validity of this 17-gene assay.
Clinical • Journal • Liquid biopsy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
7ms
All patients with nonsquamous NSCLC should have the results of testing for potentially targetable mutations (alterations) before implementing therapy for advanced lung cancer, regardless of smoking status recommendations, when possible, following other existing high-quality testing guidelines. Most patients should receive targeted therapy for these alterations: Targeted therapies against ROS-1 fusions, BRAF V600e mutations, RET fusions, MET exon 14 skipping mutations, and NTRK fusions should be offered to patients, either as initial or second-line therapy when not given in the first-line setting. New or revised recommendations include the following: Osimertinib is the optimal first-line treatment for patients with activating epidermal growth factor receptor mutations (exon 19 deletion, exon 21 L858R, and exon 20 T790M); alectinib or brigatinib is the optimal first-line treatment for patients with anaplastic lymphoma kinase fusions. For the first time, to our knowledge, the guideline includes recommendations regarding RET, MET, and NTRK alterations. Chemotherapy is still an option at most stages.Additional information is available at www.asco.org/thoracic-cancer-guidelines.
Journal
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
|
BRAF V600E • EGFR mutation • BRAF V600 • EGFR L858R • EGFR T790M • EGFR exon 19 deletion • RET fusion • MET exon 14 mutation • ALK fusion • RET mutation • ROS1 fusion • MET mutation • NTRK fusion
|
Tagrisso (osimertinib) • Alecensa (alectinib) • Alunbrig (brigatinib)
7ms
P2, N=90, Active, not recruiting, Alliance Foundation Trials, LLC. | Trial completion date: Aug 2020 --> Sep 2021 | Trial primary completion date: Sep 2019 --> Mar 2021
Clinical • Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK translocation
|
Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed
7ms
KRAS mutation status did not have a significant impact on ICI efficacy or safety. However, a non-significant trend towards worse survival was noted in patients treated with ICI whose tumours harboured the KRAS G12C variant. This study provides valuable information for comparative analysis in the future.
Clinical • Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS G12D • KRAS G12V • KRAS G12
7ms
Re-biopsy was performed in eight patients after progressive disease following the study treatment, and three patients acquired a T790M mutation. Afatinib at a dose of 30 mg/day plus bevacizumab at a dose of 15 mg/kg q3w is well tolerated.
Clinical • P1 data • Journal
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR T790M
|
Avastin (bevacizumab) • Gilotrif (afatinib)
7ms
Clinical • New trial • Review • Real-world evidence
|
NRG1 (Neuregulin 1)
|
NRG1 fusion
|
Gilotrif (afatinib)
7ms
Clinical • New P2/3 trial
|
EGFR (Epidermal growth factor receptor)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • pucotenlimab (HX008)
7ms
The BTLA rs16859629 polymorphism increased the risk of the development of squamous cell carcinoma (CC vs. TT: adjusted OR = 9.85, 95%CI = 1.37-71.03, and P = 0.023; CC vs. TT/TC: adjusted OR = 9.55, 95%CI = 1.32-68.66, and P = 0.025). Taken together, the findings of the present suggest that BTLA rs1982809 and rs16859629 polymorphisms may influence the susceptibility to NSCLC in the Chinese population.
Clinical • Journal
|
BTLA (B And T Lymphocyte Associated)
7ms
P3, N=632, Completed, Intergroupe Francophone de Cancerologie Thoracique | Active, not recruiting --> Completed
Clinical • Trial completion
|
EGFR (Epidermal growth factor receptor)
|
paclitaxel • gemcitabine • pemetrexed
7ms
P2, N=40, Recruiting, Instituto Nacional de Cancerologia de Mexico | Trial completion date: Jan 2021 --> Sep 2022 | Trial primary completion date: Dec 2020 --> Jul 2022
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
ALK (Anaplastic lymphoma kinase)
|
ALK rearrangement
|
Avastin (bevacizumab) • Alecensa (alectinib)
7ms
This meta-analysis confirmed the treatment effects of ICIs combined with chemotherapy for non-squamous NSCLC. The pembrolizumab combination group had a greater RMST benefit compared with the atezolizumab combination group. Furthermore, our study also demonstrated a PFS advantage for non-squamous NSCLC using ICIs combined with chemotherapy irrespective of programmed death-ligand 1 (PD-L1) expression level, smoking status, liver metastasis status, sex, age and ECOG score. Due to the significant increase in AEs (> grade 3), more attention should be paid to the additional use of atezolizumab.
Clinical • Retrospective data • Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • Tecentriq (atezolizumab)
7ms
EGFR mutation testing rates increased to almost 60% in the stage IV non-squamous NSCLC population in 2017, with residual opportunity for further increase. Several sociodemographic characteristics, comorbidities, and geographic regions were associated with EGFR mutation testing suggestive of inequitable testing decisions. Appropriate use of TKI improved drastically from 2013 to 2017 demonstrating rapidly changing practice patterns through the adoption phase of new treatment options.
Journal
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
7ms
The most frequently evaluated therapy was pembrolizumab (n=11), followed by bevacizumab (n=8) and erlotinib (n=4). The cost-effectiveness thresholds varied amongst sponsors but generally trended to increase over time. This review provides an overview of the available cost-effectiveness findings for stakeholders and contributes to evidence-based practice.
Review • Journal • HEOR • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • erlotinib
7ms
P1, N=135, Recruiting, Rgenix, Inc. | Trial completion date: Mar 2021 --> Mar 2022 | Trial primary completion date: Dec 2020 --> Dec 2021
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • carboplatin • Yervoy (ipilimumab) • docetaxel • pemetrexed • RGX-104
8ms
New P3 trial
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression • EGFR mutation • ALK mutation
|
carboplatin • paclitaxel • pemetrexed • zimberelimab (AB122) • domvanalimab (AB154)
8ms
P1, N=492, Recruiting, Merck Sharp & Dohme Corp. | Trial primary completion date: Sep 2023 --> Jan 2024 | Trial completion date: Sep 2023 --> Jan 2024
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • etoposide IV • pemetrexed • vibostolimab (MK-7684) • vibostolimab/pembrolizumab (MK-7684A)
8ms
P2, N=82, Active, not recruiting, Spanish Lung Cancer Group | Recruiting --> Active, not recruiting
Clinical • Enrollment closed • HEOR
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression
|
Keytruda (pembrolizumab)
8ms
Addition of nimotuzumab to the concurrent chemoradiotherapy regimen was well tolerated and showed potential for treating patients with locally advanced non-small-cell lung cancer, particularly squamous cell carcinoma.
Clinical • P2 data • Journal • Combination therapy
|
EGFR (Epidermal growth factor receptor)
|
cisplatin • vinorelbine tartrate • TheraCIM (nimotuzumab)
8ms
P3, N=559, Active, not recruiting, BeyondSpring Pharmaceuticals Inc. | Recruiting --> Active, not recruiting | Trial completion date: Nov 2020 --> Dec 2021
Clinical • Enrollment closed • Trial completion date
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR L858R • EGFR exon 19 deletion • ALK rearrangement
|
docetaxel • plinabulin (BPI 2358)
8ms
Below we report the clinical history of a patient with advanced stage adenocarcinoma of the lung with molecular diagnosis of RET fusion, treated with pralsetinib with excellent clinical and radiological response and good tolerability. This clinical case emphasizes the importance of the broader molecular profiling in patients with advanced NSCLC (especially for non-squamous histology) from the diagnosis before starting first-line treatment.
Clinical • Journal
|
RET (Ret Proto-Oncogene)
|
RET fusion • RET rearrangement
|
Gavreto (pralsetinib)
8ms
P1, N=200, Recruiting, Calithera Biosciences, Inc | Not yet recruiting --> Recruiting
Clinical • Enrollment open
|
BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • KEAP1 (Kelch Like ECH Associated Protein 1) • NFE2L2 (Nuclear Factor, Erythroid 2 Like 2) • NTRK (Neurotrophic receptor tyrosine kinase)
|
BRAF mutation • KEAP1 mutation • NFE2L2 mutation
8ms
P2, N=310, Recruiting, AbbVie | Trial completion date: Aug 2023 --> Jan 2025 | Trial primary completion date: Oct 2021 --> Jan 2025
Clinical • Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
|
EGFR mutation • MET expression
|
telisotuzumab vedotin (ABBV-399)
8ms
P3, N=532, Recruiting, Mirati Therapeutics Inc. | Trial completion date: Dec 2022 --> Jul 2023 | Trial primary completion date: Apr 2022 --> Sep 2022
Clinical • Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition
|
PD-L1 (Programmed death ligand 1)
|
Opdivo (nivolumab) • docetaxel • sitravatinib (MGCD516)
8ms
A number of trials have supported crizotinib as the best option for NSCLC patients with ROS1 translocations, irrespective of line of therapy...Among them entrectinib, also known as RXDX-101, is a potent second-generation, multitarget oral inhibitor against the neurotrophin receptors TRKA, TRKB, TRKC ALK, and ROS1 with the ability to cross the blood-brain barrier. In the next few years, results of ongoing trials with novel ROS1 inhibitors and dedicated translational research studies might help to define the optimal sequence of treatment for ROS1-positive NSCLC patients.
Review • Journal
|
ALK (Anaplastic lymphoma kinase) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • NTRK (Neurotrophic receptor tyrosine kinase)
|
ROS1 positive • ROS1 fusion • ROS1 rearrangement • ROS1 mutation
|
Xalkori (crizotinib) • Rozlytrek (entrectinib) • Lorbrena (lorlatinib)
8ms
Clinical • Enrollment closed
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • EGFR L858R • EGFR T790M • EGFR exon 19 deletion • ALK rearrangement
|
erlotinib
8ms
P1/2, N=31, Completed, Armando Santoro, MD | Active, not recruiting --> Completed
Clinical • Trial completion
|
MET (MET proto-oncogene, receptor tyrosine kinase) • HGF (Hepatocyte growth factor)
|
MET expression
|
carboplatin • pemetrexed • tivantinib (ARQ 197)
8ms
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Tecentriq (atezolizumab)
8ms
Grade 3 and 4 TRAEs were reported in 105 (7.4%) and 12 (0.8%) patients, respectively; no treatment-related deaths were reported. Preliminary results of the EVIDENS study confirm the effectiveness and safety of nivolumab, mostly in pre-treated advanced NSCLC patients, with similar benefits to those observed in the phase III randomized clinical trials, despite a broader study population.
Clinical • Journal • Real-World Evidence • PD(L)-1 Biomarker
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
Opdivo (nivolumab)
8ms
Clinical • Enrollment open • Combination therapy • Pan tumor
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 amplification • HER-2 overexpression • HER-2 mutation • CDK4 mutation
|
Herceptin (trastuzumab) • fulvestrant • Tukysa (tucatinib)
8ms
Clinical • New P3 trial
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • lenvatinib • pemetrexed
8ms
Clinical • Enrollment open • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • MK-4830
8ms
P=N/A, N=3400, Recruiting, Hoffmann-La Roche | N=2400 --> 3400 | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2026
Clinical • Enrollment change • Trial completion date • Trial primary completion date • Real-world evidence • PD(L)-1 Biomarker
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression • EGFR mutation • PD-L1 overexpression • ALK positive • ALK mutation
|
Tecentriq (atezolizumab)
8ms
Data suggest that the ABCP regimen may circumvent ICI resistance mechanisms. Continued investigation into the regimen's mechanisms, improved patient profiling/selection, and treatment personalization will drive further development/discoveries.
Clinical • Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
Avastin (bevacizumab) • carboplatin • Tecentriq (atezolizumab) • paclitaxel
8ms
P2, N=101, Completed, AIO-Studien-gGmbH | Active, not recruiting --> Completed | Trial completion date: Nov 2021 --> Dec 2020
Clinical • Trial completion • Trial completion date
|
PD-L1 (Programmed death ligand 1)
|
Opdivo (nivolumab)
8ms
P1/2, N=482, Recruiting, Institut Bergonié | N=362 --> 482 | Trial completion date: May 2021 --> May 2022 | Trial primary completion date: Nov 2020 --> Nov 2021
Enrollment change • Trial completion date • Trial primary completion date • PD(L)-1 Biomarker
|
BRAF (B-raf proto-oncogene) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • MSI (Microsatellite instability)
|
ALK positive • ROS1 positive • ALK mutation
|
Bavencio (avelumab) • Stivarga (regorafenib)
8ms
Long-term survival with nivolumab was observed in patients with squamous or non-squamous non-small cell lung cancer. No new safety signals were reported after ≥5 years of follow-up.
P2 data • Retrospective data • Journal • PD(L)-1 Biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Opdivo (nivolumab)
8ms
Clinical • Enrollment open • Combination therapy • PD(L)-1 Biomarker
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • EML4 (EMAP Like 4)
|
EGFR mutation • EML4-ALK fusion • ALK fusion • ROS1 fusion • ALK mutation • ROS1 mutation
|
cisplatin • carboplatin • Imfinzi (durvalumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • pemetrexed
8ms
New trial • Clinical
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
|
ROS1 fusion • NTRK fusion
|
LiquidHALLMARK®
8ms
Clinical • Trial completion date
|
EGFR (Epidermal growth factor receptor)
|
EGFR expression • EGFR overexpression
|
cisplatin • pemetrexed • Portrazza (necitumumab)
8ms
P2, N=379, Completed, Intergroupe Francophone de Cancerologie Thoracique | Active, not recruiting --> Completed
Clinical • Trial completion
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
erlotinib • gefitinib • fulvestrant
8ms
Combination therapy • Enrollment open • Clinical
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR T790M • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR L861Q • EGFR G719X
|
cobas® EGFR Mutation Test v2
|
cisplatin • Tagrisso (osimertinib) • carboplatin • pemetrexed
8ms
In addition, based on the KN158 trial and considering that patients with endometrial and small-cell lung cancers should have broad access to anti-programmed cell death 1 (anti-PD1) antibodies, it is recommended to test tumour mutational burden (TMB) in cervical cancers, well- and moderately-differentiated neuroendocrine tumours, salivary cancers, thyroid cancers and vulvar cancers, as TMB-high predicted response to pembrolizumab in these cancers...ESMO recommends that the use of off-label drugs matched to genomics is done only if an access programme and a procedure of decision has been developed at the national or regional level. Finally, ESMO recommends that clinical research centres develop multigene sequencing as a tool to screen patients eligible for clinical trials and to accelerate drug development, and prospectively capture the data that could further inform how to optimise the use of this technology.
Clinical • Review • Journal • Next-generation sequencing • Tumor Mutational Burden • PD(L)-1 Biomarker • IO biomarker
|
TMB (Tumor Mutational Burden)
|
TMB-H
|
Keytruda (pembrolizumab)
8ms
The findings of this study suggest that exposure to the NCCN guidelines is associated with increased guideline-concordant care for 2 of 6 preselected recommendations and improvement in decisional conflict. ClinicalTrials.gov Identifier: NCT03982459.
Clinical • NCCN guideline • Journal
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
8ms
New P1 trial • Clinical
|
BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • KEAP1 (Kelch Like ECH Associated Protein 1) • NFE2L2 (Nuclear Factor, Erythroid 2 Like 2) • NTRK (Neurotrophic receptor tyrosine kinase)
|
BRAF mutation • KEAP1 mutation • NFE2L2 mutation
|
Guardant360® CDx
8ms
P2, N=30, Active, not recruiting, Nasser Hanna | Recruiting --> Active, not recruiting | N=46 --> 30 | Trial completion date: Nov 2021 --> Jul 2022 | Trial primary completion date: Nov 2020 --> Jul 2021
Clinical • Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
PD-L1 expression • EGFR mutation • BRAF mutation • PD-L1 negative • ALK translocation
|
Avastin (bevacizumab) • carboplatin • Tecentriq (atezolizumab) • pemetrexed
8ms
Clinical • Trial initiation date • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase)
|
PD-L1 expression • KRAS mutation
|
carboplatin • Imfinzi (durvalumab) • pemetrexed
8ms
Clinical • New P2 trial • Tumor Mutational Burden
|
PD-L1 (Programmed death ligand 1) • PIAS4 (Protein Inhibitor Of Activated STAT 4)
|
PD-L1 expression
|
carboplatin • gemcitabine • Imfinzi (durvalumab) • tremelimumab (CP-675206) • pemetrexed
8ms
P1, N=225, Recruiting, AbbVie | Trial completion date: May 2023 --> Feb 2022 | Trial primary completion date: May 2023 --> Feb 2022
Clinical • Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
|
EGFR mutation • EGFR L858R
|
Opdivo (nivolumab) • erlotinib • Tagrisso (osimertinib) • telisotuzumab vedotin (ABBV-399)
8ms
Clinical • New P3 trial • Combination therapy
|
EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53)
|
TP53 mutation • EGFR mutation • EGFR L858R • EGFR exon 19 deletion
|
Tagrisso (osimertinib) • carboplatin • pemetrexed
9ms
A systematic review of bibliographic databases for peer-reviewed research literature and of key meetings was undertaken in order to discuss these topics.Expert opinion: Many emerging driver mutations are being investigated in metastatic NSCLC. Defining the most appropriate methods of detection of molecular aberrations, focusing on their role in the mechanisms of intrinsic and acquired resistance within appropriate preclinical and clinical trials, are needed in order to improve therapeutic benefit for NSCLC patients.
Journal
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR mutation • BRAF mutation • ALK rearrangement • ROS1 rearrangement • BRAF mutation + EGFR mutation