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BMS Recruiting Study icon

Recruiting

Trial ID CA224-1093  |   NCT06561386

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%

Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • 105
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 1-49%

Nearest Recruiting Site

Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • 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
    1. Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria.
      1. Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening.
        1. Participants must have no prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic disease.

          Exclusion Criteria

          Exclusion Criteria Icon
          • 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.
            1. Participants must not have untreated central nervous system (CNS) metastases.
              1. Participants must not have concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization.
                1. Participants must not have an active autoimmune disease.
                  1. Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids.
                    1. Participants must not have a history of myocarditis, regardless of etiology.
                      1. 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.
                        Additional Information *
                        • Other protocol-defined Inclusion/Exclusion criteria apply.

                          Treatment Options

                          Study Arms

                          ASSIGNED INTERVENTION

                          Study Arms

                          Experimental: Arm A

                          ASSIGNED INTERVENTION
                          • Drug: Nivolumab, Relatlimab, Carboplatin, Pemetrexed, Cisplatin

                          Study Arms

                          Active Comparator: Arm B

                          ASSIGNED INTERVENTION
                          • Drug: Pembrolizumab, Carboplatin, Pemetrexed, Cisplatin
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