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Recruiting

A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 1-49% - CA224-1093

Updated: 11 December, 2024   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 112

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Arm A
Drug: Nivolumab, Relatlimab, Carboplatin, Pemetrexed, Cisplatin
Active Comparator: Arm B
Drug: Pembrolizumab, Carboplatin, Pemetrexed, Cisplatin

Key Eligibility Criteria

Inclusion Criteria - Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with tumor cell PD-L1 expression 1% to 49% as determined by a central laboratory - Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria. - Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening. - Participants must have no prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic disease. Exclusion Criteria - Participants must not have epidermal growth factor receptor (EGFR) mutations, anaplastic lymphoma kinase (ALK) translocations, ROS-1 translocations and known BRAFV600E, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations and neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations. - Participants must not have untreated central nervous system (CNS) metastases. - Participants must not have concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization. - Participants must not have an active autoimmune disease. - Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids. - Participants must not have a history of myocarditis, regardless of etiology. - Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways. - Other protocol-defined Inclusion/Exclusion criteria apply.

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