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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: 29 October, 2024   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
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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

  • 106

    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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