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CANCER:

Lung Non-Small Cell Squamous Cancer

Related cancers:
3d
Serum CYFRA 21-1 as a Prognostic Marker in Non-Small-Cell Lung Cancer Patients Treated with Immune Checkpoint Inhibitors. (PubMed, Cancers (Basel))
Patients with high serum CYFRA 21-1 levels exhibited a significantly shorter OS even focusing on non-squamous NSCLC, anti-PD-1/PD-L1 antibody and chemotherapy combination therapy, or anti-CTLA-4 antibody combination therapy. Serum CYFRA 21-1 is a poor prognostic marker for patients with NSCLC receiving anti-PD-1/PD-L1 antibody treatment even when stratifying by histology or treatment regimen.
Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
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CEACAM5 (CEA Cell Adhesion Molecule 5)
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PD-L1 expression
5d
KEYNOTE-E02: Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors (clinicaltrials.gov)
P2, N=692, Recruiting, Seagen Inc. | Trial primary completion date: Apr 2025 --> Feb 2026
Trial primary completion date
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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Keytruda (pembrolizumab) • cisplatin • carboplatin • Tivdak (tisotumab vedotin-tftv)
8d
New P2 trial • Combination therapy • Metastases
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EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
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EGFR mutation • ALK fusion
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gemcitabine • Epidaza (chidamide) • Ariely (adebrelimab)
8d
New P1/2 trial • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
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PD-L1 expression • EGFR mutation • ALK mutation • PD-L1 amplification
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PD-L1 IHC 22C3 pharmDx
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cisplatin • carboplatin • Enshuxing (enlonstobart)
12d
Enrollment change • Combination therapy • Metastases
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Keytruda (pembrolizumab) • Lynparza (olaparib) • carboplatin • albumin-bound paclitaxel
14d
MT-6402-001: Study of MT-6402 in Subjects With Advanced Solid Cancer That Expresses PD-L1 (clinicaltrials.gov)
P1, N=64, Terminated, Molecular Templates, Inc. | N=138 --> 64 | Active, not recruiting --> Terminated; Terminated by Sponsor
Enrollment change • Trial termination • IO biomarker • Metastases
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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MT-6402
17d
Enrollment closed
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BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden)
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Avastin (bevacizumab) • cisplatin • Tecentriq (atezolizumab) • Zelboraf (vemurafenib) • carboplatin • gemcitabine • Rozlytrek (entrectinib) • docetaxel • Alecensa (alectinib) • Cotellic (cobimetinib) • pemetrexed • divarasib (RG6330)
17d
MT-8421-001: Study of MT-8421 as Monotherapy and in Combination With Nivolumab in Patients With Selected Advanced Solid Cancer Types (clinicaltrials.gov)
P1, N=15, Terminated, Molecular Templates, Inc. | Active, not recruiting --> Terminated; Sponsor Termination
Trial termination
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PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • PD-1 (Programmed cell death 1)
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MSI-H/dMMR
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Opdivo (nivolumab) • MT-8421
21d
Trial termination
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KRAS (KRAS proto-oncogene GTPase) • NTRK (Neurotrophic receptor tyrosine kinase)
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KRAS mutation • KRAS G12C • KRAS G12 • FGFR2 overexpression • FGFR2b overexpression
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Keytruda (pembrolizumab) • carboplatin • docetaxel • albumin-bound paclitaxel • bemarituzumab (AMG 552)
28d
MT-6402-001: Study of MT-6402 in Subjects With Advanced Solid Cancer That Expresses PD-L1 (clinicaltrials.gov)
P1, N=138, Active, not recruiting, Molecular Templates, Inc. | Recruiting --> Active, not recruiting | Trial completion date: May 2026 --> Oct 2024 | Trial primary completion date: Apr 2025 --> Oct 2024
Enrollment closed • Trial completion date • Trial primary completion date • IO biomarker • Metastases
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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MT-6402
28d
MT-8421-001: Study of MT-8421 as Monotherapy and in Combination With Nivolumab in Patients With Selected Advanced Solid Cancer Types (clinicaltrials.gov)
P1, N=15, Active, not recruiting, Molecular Templates, Inc. | Recruiting --> Active, not recruiting | N=200 --> 15 | Trial completion date: Oct 2026 --> Oct 2024 | Trial primary completion date: Jul 2026 --> Oct 2024
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
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PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • PD-1 (Programmed cell death 1)
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MSI-H/dMMR
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Opdivo (nivolumab) • MT-8421
1m
DIAL: De-escalation Immunotherapy MAintenance Duration Trial for Stage IV Lung Cancer Patients with Disease Control After Chemo-immunotherapy Induction (clinicaltrials.gov)
P2/3, N=1360, Recruiting, Intergroupe Francophone de Cancerologie Thoracique | Trial primary completion date: Jun 2024 --> Jan 2025
Trial primary completion date • Metastases
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PD-L1 (Programmed death ligand 1)
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Keytruda (pembrolizumab) • cisplatin • carboplatin • paclitaxel • pemetrexed
1m
DISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLC (clinicaltrials.gov)
P2, N=24, Not yet recruiting, University of Alabama at Birmingham | Initiation date: Oct 2024 --> Jan 2025
Trial initiation date • Checkpoint inhibition
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PD-L1 (Programmed death ligand 1)
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PD-L1 negative
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • carboplatin • paclitaxel • pemetrexed
1m
Enrollment open • Metastases
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Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel • pemetrexed • patritumab deruxtecan (U3-1402) • ifinatamab deruxtecan (DS-7300) • vibostolimab (MK-7684) • MK-0482 • MK-4830
1m
IRRADIATE-Lung: Immunotherapy With Non-Ablative Radiation in Previously Untreated Patients With Stage IV NSCLC (clinicaltrials.gov)
P2, N=14, Active, not recruiting, NYU Langone Health | Recruiting --> Active, not recruiting | N=40 --> 14 | Trial completion date: Jan 2026 --> Aug 2025 | Trial primary completion date: Jan 2025 --> Jun 2024
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
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Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel
1m
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC (clinicaltrials.gov)
P1, N=48, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Sep 2024 --> Jan 2025
Trial completion date • Metastases
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EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
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EGFR mutation • EGFR mutation + ALK mutation
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carboplatin • albumin-bound paclitaxel • pemetrexed
1m
Long-Term Survival Outcomes With First-Line Nivolumab Plus Ipilimumab-Based Treatment in Patients With Metastatic Non-Small Cell Lung Cancer and Tumor PD-L1 <1%: a Pooled Analysis. (PubMed, J Thorac Oncol)
Nivolumab plus ipilimumab with or without chemotherapy provides a long-term, durable clinical benefit in patients with metastatic NSCLC and tumor PD-L1 <1%, supporting the use of this strategy as a first-line treatment option in this population with high unmet need.
Retrospective data • Journal • Metastases
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
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Opdivo (nivolumab) • Yervoy (ipilimumab)
2ms
Stereotactic Body Radiation Therapy for Inoperable Locally-advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
P1, N=39, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jul 2025 --> Oct 2024 | Trial primary completion date: Jul 2025 --> Oct 2024
Trial completion • Trial completion date • Trial primary completion date
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cisplatin • carboplatin
2ms
Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=320, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
Enrollment closed
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PD-L1 expression
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tobemstomig (RG6139)
2ms
Enrollment change
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Erbitux (cetuximab) • docetaxel • HMBD-001
2ms
Enrollment open
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Tevimbra (tislelizumab-jsgr)
2ms
Real-world evidence • Journal • Next-generation sequencing • Real-world
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HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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BRAF V600E • KRAS mutation • EGFR mutation • KRAS G12C • BRAF V600 • ALK positive • MET amplification • RET fusion • ALK rearrangement • MET exon 14 mutation • EGFR C797S • RET mutation • ROS1 fusion • MET mutation • KRAS G12 • ALK negative
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ACTOnco
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Tagrisso (osimertinib)
2ms
Calibrating Observational Health Record Data Against a Randomized Trial. (PubMed, JAMA Netw Open)
Initiation of first-line pembrolizumab and chemotherapy and chemotherapy alone. Chemotherapy in both groups was defined as a combination of pemetrexed and platinum-based (carboplatin or cisplatin) therapy...Differences in patient treatment and data capture between the RCT and EHR populations, confounding by indication, treatment crossover, and accuracy of captured diagnoses may explain these findings. Future feasibility assessments will require data sources to have important oncology-specific measures curated.
Clinical • Journal
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EGFR (Epidermal growth factor receptor)
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Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed
2ms
Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression (clinicaltrials.gov)
P1/2, N=288, Recruiting, BicycleTx Limited | Trial completion date: Dec 2024 --> Oct 2026
Trial completion date
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CD4 (CD4 Molecule) • EPHA2 (EPH receptor A2)
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Opdivo (nivolumab) • BT5528
2ms
Enrollment open • Checkpoint inhibition
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • cisplatin • Tecentriq (atezolizumab) • carboplatin • Imfinzi (durvalumab) • docetaxel • albumin-bound paclitaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • olvimulogene nanivacirepvec (GL-ONC1)
2ms
Induction Chemo-Nivo in Unresectable Stage III NSCLC (clinicaltrials.gov)
P2, N=1, Terminated, Ralph G Zinner | N=37 --> 1 | Trial completion date: Aug 2027 --> Jul 2024 | Recruiting --> Terminated | Trial primary completion date: Jun 2025 --> Jul 2024; Slow accrual
Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Surgery
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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ALK wild-type • ROS1 wild-type
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Opdivo (nivolumab) • paclitaxel • docetaxel
2ms
Phase classification • Enrollment change • Combination therapy • Metastases
|
carboplatin • paclitaxel • ganitumab (AMG 479)
2ms
Neoadjuvant With Tα1 Plus Immuno-chemotherapy for Resectable NSCLC (clinicaltrials.gov)
P=N/A, N=40, Not yet recruiting, Xuanwu Hospital, Beijing
New trial
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cisplatin • carboplatin • paclitaxel • Tevimbra (tislelizumab-jsgr) • Zadaxin (thymalfasin)
2ms
ALK Tyrosine Kinase Inhibitors in ALK-rearranged Advanced Squamous Cell Carcinoma (clinicaltrials.gov)
P2, N=90, Recruiting, Hunan Province Tumor Hospital | Phase classification: P --> P2
Phase classification • Metastases
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ALK (Anaplastic lymphoma kinase)
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ALK positive
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Xalkori (crizotinib) • carboplatin • paclitaxel • Alecensa (alectinib) • Lorbrena (lorlatinib) • pemetrexed • Alunbrig (brigatinib)
2ms
Phase classification • Metastases
|
Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel • pemetrexed • patritumab deruxtecan (U3-1402) • ifinatamab deruxtecan (DS-7300) • vibostolimab (MK-7684) • MK-0482 • MK-4830
2ms
Afuresertib +Sintilimab+Chemotherapy in Patients with Selected Solid Tumors That Resistance to Prior Anti-PD-1/PD-L1 (clinicaltrials.gov)
P1/2, N=22, Active, not recruiting, Laekna Limited | Recruiting --> Active, not recruiting | N=167 --> 22
Enrollment closed • Enrollment change
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HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • PTEN (Phosphatase and tensin homolog) • PI3K (Phosphoinositide 3-kinases)
|
ALK rearrangement • EGFR wild-type • KRAS wild-type • RAS wild-type • ALK negative
|
docetaxel • Tyvyt (sintilimab) • albumin-bound paclitaxel • afuresertib (LAE002)
2ms
New trial
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
ALK mutation
2ms
NIRVANA-LUNG: PD-1 Inhibitor and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
P3, N=327, Active, not recruiting, UNICANCER | Recruiting --> Active, not recruiting | Trial completion date: Sep 2026 --> Jul 2027 | Trial primary completion date: Sep 2026 --> Jan 2026
Enrollment closed • Trial completion date • Trial primary completion date • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK positive • ALK translocation
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed
2ms
Atezolizumab Combined With Platinum-based Chemotherapy as Neoadjuvant Therapy for Patients With Resectable Stage II-IIIB (clinicaltrials.gov)
P2, N=120, Recruiting, Hunan Province Tumor Hospital | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jun 2024 --> Dec 2024
Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
ALK positive • EGFR positive
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Tecentriq (atezolizumab) • carboplatin • paclitaxel
2ms
Antithetical impacts of deleterious LRP1B mutations in non-squamous and squamous NSCLCs on predicting benefits from immune checkpoint inhibitor alone or with chemotherapy over chemotherapy alone: retrospective analyses of the POPLAR/OAK and CHOICE-01 trials. (PubMed, Sci China Life Sci)
In the POPLAR/OAK cohort, nsqNSCLCs with LRP1B-del demonstrated improved PFS benefits from atezolizumab over docetaxel (hazard ratio (HR) =0.70, P=0.046), whereas this benefit was negligible in those without LRP1B-del (HR=1.05, P=0.64)...Consistent results were observed in the in-house CHOICE-01 cohort, in which nsqNSCLCs with LRP1B-del and sqNSCLCs without LRP1B-del benefited more from toripalimab plus chemotherapy than from chemotherapy alone (Pinteraction=0.008). This multi-cohort study delineates the antithetical impacts of LRP1B-del in nsqNSCLCs and sqNSCLCs on predicting the benefits from ICI alone or with chemotherapy over chemotherapy alone. Our findings highlight the distinct clinical utility of LRP1B-del in guiding treatment choices for nsqNSCLCs and sqNSCLCs, emphasizing the necessity for a detailed analysis based on pathological subtypes when investigating biomarkers for cancer therapeutics.
Retrospective data • Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
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CD8 (cluster of differentiation 8) • LRP1B (LDL Receptor Related Protein 1B)
|
LRP1B mutation • LRP1B deletion
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Tecentriq (atezolizumab) • docetaxel • Loqtorzi (toripalimab-tpzi)
2ms
β-glucan combined with Envafolimab and Endostar as immune rechallenge for metastatic non-small cell lung cancer. (PubMed, BMC Immunol)
β-glucan combined with Envafolimab and Endostar has considerable efficacy and safety for immune rechallenge in metastatic NSCLC patients who failed of anti-PD-1 treatment previously, especially for PD-L1 positive patients.
Clinical • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
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CASP8 (Caspase 8) • ARG1 (Arginase 1) • CD40LG (CD40 ligand) • CXCL5 (Chemokine (C-X-C motif) ligand 5)
|
PD-L1 expression
|
Enweida (envafolimab) • Endostar (recombinant human endostatin)
2ms
Identifying patients who benefit more from perioperative immunotherapy combinations for resectable non-small cell lung cancer based on clinical and molecular characteristics: a meta-analysis of randomized clinical trials. (PubMed, Clin Transl Oncol)
Perioperative IO-CT is more effective but more toxic than CT alone in resectable NSCLC. Patients with PD-L1 ≥ 1%, squamous NSCLC, a history of smoking, age < 65 years and male gender may experience greater benefits from perioperative IO-CT.
Clinical • Retrospective data • Journal
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PD-L1 (Programmed death ligand 1)
3ms
Trial completion • Metastases
|
lomvastomig (RG7769)
3ms
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
ALK (Anaplastic lymphoma kinase)
|
balstilimab (AGEN2034) • botensilimab (AGEN1181)
3ms
PEMBRO-K : Evaluation of Pembrolizumab Therapeutic Pharmacological Monitoring Benefit in NSCLC (clinicaltrials.gov)
P=N/A, N=75, Not yet recruiting, University Hospital, Angers | Trial completion date: Apr 2026 --> Nov 2026 | Initiation date: Apr 2024 --> Nov 2024 | Trial primary completion date: Apr 2025 --> Nov 2025
Trial completion date • Trial initiation date • Trial primary completion date
|
Keytruda (pembrolizumab)
3ms
QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors (clinicaltrials.gov)
P1/2, N=89, Terminated, NantCell, Inc. | Phase classification: P1b/2 --> P1/2
Phase classification • Combination therapy • Metastases
|
ganitumab (AMG 479) • conatumumab (AMG 655)
3ms
PRIME_LUNG: Primary Radiotherapy In MEtastatic Lung Cancer - A Pilot Study (clinicaltrials.gov)
P1, N=40, Recruiting, Peter MacCallum Cancer Centre, Australia | Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Apr 2024 --> Apr 2025
Trial completion date • Trial primary completion date • Metastases
|
EGFR (Epidermal growth factor receptor) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
Keytruda (pembrolizumab) • carboplatin • paclitaxel