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)

Active, Not Recruiting

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) - CA047-1009

Updated: 24 June, 2024 | ClinicalTrials.gov

About This Trial
Key Eligibility Criteria

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Trial Details

Phase 2

Phase
Gender(s)
18+

Age Range
Active, Not Recruiting

Treatment Options

Study Arms

ASSIGNED INTERVENTION

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

Drug: BMS-986315, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel

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

Drug: BMS-986315, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel

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

Drug: BMS-986315, Nivolumab, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel

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

Drug: BMS-986315, Nivolumab, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel

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

Drug: Nivolumab, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel

Key Eligibility Criteria

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

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