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BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

Trial ID CA047-1009  |   NCT06094296

A Study of BMS-986315 and Nivolumab in Combination With Chemotherapy in Participants With First-line Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

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Sorry, this study is no longer accepting new participants, but is still ongoing.
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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 evaluate the efficacy and safety of BMS-986315 plus nivolumab in combination with platinum-based doublet chemotherapy (PDCT) versus nivolumab in combination with PDCT in the first-line treatment of Stage IV or recurrent non-small cell lung cancer (NSCLC).

Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Participants must have NSCLC with Stage IV or recurrent disease following multimodal therapy for locally advanced disease.
    1. Study treatment must be first-line therapy for Stage IV or recurrent disease.
      1. Participants in all parts of the study must have:
        1. measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1. (RECIST v1.1)
          1. an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
            1. a life expectancy of at least 3 months at the time of first dose

              Exclusion Criteria

              Exclusion Criteria Icon
              :
              • Untreated symptomatic central nervous system metastases
                1. Participants with epidermal growth factor receptor (EGFR)/ALK receptor tyrosine kinase (ALK)/ROS proto-oncogene 1 (ROS1)/neurotrophic tyrosine receptor kinase (NTRK)/MET proto-oncogene (MET)/B-Raf proto-oncogene (BRAF)/RET proto-oncogene (RET) mutations amenable to targeted therapies
                  1. Participants with any known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results Note: Other protocol-defined inclusion/exclusion criteria apply.
                    Additional Information *

                    Treatment Options

                    Study Arms

                    ASSIGNED INTERVENTION

                    Study Arms

                    Experimental: Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986315, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel

                    Study Arms

                    Experimental: Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986315, Pemetrexed, Carboplatin, Paclitaxel, Cisplatin

                    Study Arms

                    Experimental: Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986315, Nivolumab, Paclitaxel, Cisplatin, Carboplatin, Pemetrexed

                    Study Arms

                    Experimental: Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986315, Nivolumab, Paclitaxel, Cisplatin, Carboplatin, Pemetrexed

                    Study Arms

                    Active Comparator: Part 2: Nivolumab + Histology-based PDCT

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

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