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    CANCER:

    Lung Non-Small Cell Squamous Cancer

    Related cancers:
    16h
    A Phase II, Single-arm, Single-centre Trial to Evaluate the Efficacy and Safety of Nalusobasumab in Combination with Stereotactic Radiosurgery to Improve the Efficacy of First-line Chemotherapy Combined with Immunotherapy in Patients with Bone Metastases from Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=27, Not yet recruiting, Fudan University
    New P2 trial • Combination therapy • IO biomarker • Surgery
    3d
    KEYNOTE-D13: A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=166, Terminated, SOTIO Biotech AG | Active, not recruiting --> Terminated; Due to lack of expected efficacy shown at the time of the interim analysis
    Trial termination • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    5d
    A Study of Pembrolizumab With or Without Chemotherapy in Combination With Additional Treatments for Advanced Non-Small Cell Lung Cancer (NSCLS) (MK-3475-01G/KEYMAKER U01) (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Merck Sharp & Dohme LLC
    New P2 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel • pemetrexed • patritumab deruxtecan (U3-1402)
    6d
    Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Virginia Commonwealth University
    New P2 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel
    7d
    ARTEMIDE-Lung02: A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P3, N=880, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel • rilvegostomig (AZD2936)
    8d
    ARTEMIA: Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor (clinicaltrials.gov)
    P3, N=363, Recruiting, OSE Immunotherapeutics | Not yet recruiting --> Recruiting | Initiation date: Jun 2024 --> Dec 2024
    Enrollment open • Trial initiation date • Checkpoint inhibition • Metastases
    |
    docetaxel • Tedopi (OSE 2101)
    9d
    Study of Eftilagimod Alfa (Efti) in Combination with Pembrolizumab and Chemotherapy Versus Placebo in Combination with Pembrolizumab and Chemotherapy in Participants with Metastatic Non-Small Cell Lung Cancer (NSCLC) (TACTI-004) (clinicaltrials.gov)
    P3, N=756, Not yet recruiting, Immutep S.A.S.
    New P3 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • paclitaxel • pemetrexed • ImmuFact (eftilagimod alpha)
    13d
    Chemotherapy Plus Immunotherapy Combined With SBRT as Neoadjuvant Therapy for Patients With Resectable NSCLC (clinicaltrials.gov)
    P2, N=40, Recruiting, First People's Hospital of Hangzhou
    New P2 trial
    |
    cisplatin • carboplatin • paclitaxel
    21d
    A Clinical Study of MK-3475A to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84) (clinicaltrials.gov)
    P3, N=160, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Keytruda (pembrolizumab)
    26d
    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: Oct 2026 --> Oct 2025
    Trial completion date • Metastases
    |
    CD4 (CD4 Molecule) • EPHA2 (EPH receptor A2)
    |
    Opdivo (nivolumab) • BT5528
    28d
    A Clinical Study of MK-3475A to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84) (clinicaltrials.gov)
    P3, N=160, Not yet recruiting, Merck Sharp & Dohme LLC
    New P3 trial • Metastases
    |
    Keytruda (pembrolizumab)
    29d
    A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=180, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Mar 2028 --> Jun 2026 | Trial primary completion date: Mar 2026 --> Jun 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • tobemstomig (RG6139)
    29d
    Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Resectable Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P=N/A, N=20, Recruiting, Ruijin Hospital | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Avastin (bevacizumab) • carboplatin • Tyvyt (sintilimab)
    30d
    BRIO: Propranolol Hydrochloride in Combination With Sintilimab and Platinum-based Chemotherapy for Treatment of Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=6, Recruiting, Second Xiangya Hospital of Central South University | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK fusion • ROS1 fusion
    |
    cisplatin • carboplatin • Tyvyt (sintilimab) • albumin-bound paclitaxel
    1m
    ARTEMIDE-Lung02: A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P3, N=880, Not yet recruiting, AstraZeneca
    New P3 trial • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel • rilvegostomig (AZD2936)
    1m
    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
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    PD-L1 expression
    1m
    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
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • Tivdak (tisotumab vedotin-tftv)
    1m
    Adebrelimab plus Chidamide in combination with Gemcitabine in patients with advanced squamous-cell non-small-cell lung cancer who previously progressed during or after treatment of PD-1 inhibitors (L-Aunching/SCOG-L003): A prospective, single-arm, exploratory trial (ChiCTR2400090083)
    P2, N=30, Not yet recruiting, The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Soochow University
    New P2 trial • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK fusion
    |
    gemcitabine • Epidaza (chidamide) • Ariely (adebrelimab)
    1m
    A Phase Ⅰ/II Clinical Study of SYS6010 in combination with Enlonstobart ± chemotherapy in patients with locally advanced or metastatic NSCLC and other advanced solid tumor (ChiCTR2400089402)
    P1/2, N=540, Not yet recruiting, Shanghai East Hospital; CSPC Megalith Biopharmaceutical Co., Ltd.
    New P1/2 trial • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • EGFR mutation • ALK mutation • PD-L1 amplification
    |
    PD-L1 IHC 22C3 pharmDx
    |
    cisplatin • carboplatin • Enshuxing (enlonstobart)
    1m
    A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008) (clinicaltrials.gov)
    P3, N=851, Active, not recruiting, Merck Sharp & Dohme LLC | N=591 --> 851
    Enrollment change • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Lynparza (olaparib) • carboplatin • albumin-bound paclitaxel
    1m
    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
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    MT-6402
    2ms
    BFAST: A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2/3, N=1000, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden)
    |
    Avastin (bevacizumab) • cisplatin • Tecentriq (atezolizumab) • Zelboraf (vemurafenib) • carboplatin • gemcitabine • Rozlytrek (entrectinib) • docetaxel • Alecensa (alectinib) • Cotellic (cobimetinib) • pemetrexed • divarasib (RG6330)
    2ms
    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
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • PD-1 (Programmed cell death 1)
    |
    MSI-H/dMMR
    |
    Opdivo (nivolumab) • MT-8421
    2ms
    A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201) (clinicaltrials.gov)
    P1, N=74, Terminated, Amgen | Completed --> Terminated; Business decision not due to safety concerns
    Trial termination
    |
    KRAS (KRAS proto-oncogene GTPase) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • KRAS G12C • KRAS G12 • FGFR2 overexpression • FGFR2b overexpression
    |
    Keytruda (pembrolizumab) • carboplatin • docetaxel • albumin-bound paclitaxel • bemarituzumab (AMG 552)
    2ms
    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
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    MT-6402
    2ms
    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
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • PD-1 (Programmed cell death 1)
    |
    MSI-H/dMMR
    |
    Opdivo (nivolumab) • MT-8421
    2ms
    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
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • paclitaxel • pemetrexed
    2ms
    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
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 negative
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • carboplatin • paclitaxel • pemetrexed
    2ms
    KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A) (clinicaltrials.gov)
    P1/2, N=450, Recruiting, Merck Sharp & Dohme LLC | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel • pemetrexed • patritumab deruxtecan (U3-1402) • ifinatamab deruxtecan (DS-7300) • vibostolimab (MK-7684) • MK-0482 • MK-4830
    2ms
    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
    |
    Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel
    2ms
    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
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • EGFR mutation + ALK mutation
    |
    carboplatin • albumin-bound paclitaxel • pemetrexed
    2ms
    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
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    3ms
    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
    |
    cisplatin • carboplatin
    3ms
    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
    |
    PD-L1 expression
    |
    tobemstomig (RG6139)
    3ms
    Study of an Anti-HER3 Antibody, HMBD-001, with Docetaxel +/- Cetuximab in Advanced Squamous Non-small Cell Lung Cancers, and HMBD-001 + Cetuximab in Advance Squamous Cell Cancers (clinicaltrials.gov)
    P1/2, N=98, Recruiting, Hummingbird Bioscience | N=62 --> 98
    Enrollment change
    |
    Erbitux (cetuximab) • docetaxel • HMBD-001
    3ms
    A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab, in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=140, Recruiting, BeiGene | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Tevimbra (tislelizumab-jsgr)
    3ms
    Registry of Genetic Alterations of Taiwan Non-Small Cell Lung Cancer by Comprehensive Next-Generation Sequencing: A Real-World Cohort Study-Taiwan Cooperative Oncology Group T1521. (PubMed, JCO Glob Oncol)
    This multicenter registration study investigated tissue-based NGS for a specific patient population with NSCLC in Taiwan.
    Real-world evidence • Journal • Next-generation sequencing • Real-world
    |
    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)
    |
    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
    |
    ACTOnco
    |
    Tagrisso (osimertinib)
    3ms
    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
    |
    EGFR (Epidermal growth factor receptor)
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed
    3ms
    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
    |
    CD4 (CD4 Molecule) • EPHA2 (EPH receptor A2)
    |
    Opdivo (nivolumab) • BT5528
    3ms
    Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's of Choice Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer (VIRO-25) (clinicaltrials.gov)
    P2, N=142, Recruiting, Genelux Corporation | Not yet recruiting --> Recruiting
    Enrollment open • Checkpoint inhibition
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • cisplatin • Tecentriq (atezolizumab) • carboplatin • Imfinzi (durvalumab) • docetaxel • albumin-bound paclitaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • olvimulogene nanivacirepvec (GL-ONC1)
    3ms
    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
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK wild-type • ROS1 wild-type
    |
    Opdivo (nivolumab) • paclitaxel • docetaxel
    3ms
    QUILT-2.017: Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for 1st Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=15, Terminated, NantCell, Inc. | Phase classification: P1b/2 --> P1/2 | N=49 --> 15
    Phase classification • Enrollment change • Combination therapy • Metastases
    |
    carboplatin • paclitaxel • ganitumab (AMG 479)