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Trial ID CA224-104  |   NCT04623775

A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

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Summary

  • Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Histologically confirmed metastatic non-small cell lung cancer (NSCLC) of squamous (SQ) or non-squamous (NSQ) histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease.
    1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or equal to 1 at screening and confirmed prior to randomization.
      1. Measurable disease by computed tomography (CT) or magnetic resonance resources (MRI) per response evaluation criteria in solid tumor version 1.1 (RECIST 1.1) criteria.
        1. No prior systemic anti-cancer treatment (including epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for advanced or metastatic disease.

          Exclusion Criteria

          Exclusion Criteria Icon
          • Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy.
            1. Untreated CNS metastases.
              1. Leptomeningeal metastases (carcinomatous meningitis).
                1. Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the participant has no evidence of disease).
                  1. Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically 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: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))

                      ASSIGNED INTERVENTION
                      • Biological: Nivolumab, Relatlimab
                      • Drug: Carboplatin, Cisplatin, Paclitaxel, Nab-Paclitaxel, Pemetrexed

                      Study Arms

                      Experimental: Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))

                      ASSIGNED INTERVENTION
                      • Biological: Nivolumab, Relatlimab
                      • Drug: Carboplatin, Cisplatin, Paclitaxel, Nab-Paclitaxel, Pemetrexed

                      Study Arms

                      Experimental: Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)

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

                      Study Arms

                      Active Comparator: Part 2: Arm D (Nivolumab + PDCT)

                      ASSIGNED INTERVENTION
                      • Biological: Nivolumab
                      • Drug: Carboplatin, Cisplatin, Paclitaxel, Pemetrexed

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