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)

Stopped early · Phase 2

Conditions studied: NSCLC

In brief

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 facts

Study ID

NCT06094296

Run by

Bristol-Myers Squibb

People needed

1

Starts

2023-11-27

Expected to finish

2024-08-08

Last updated by the study team

2025-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Local Institution - 0038 — Glendale, California, United States
• Local Institution - 0044 — Clermont, Florida, United States
• Local Institution - 0040 — Orange City, Florida, United States
• Local Institution - 0058 — Boise, Idaho, United States
• Local Institution - 0049 — Houston, Texas, United States
• Local Institution - 0013 — St Leonards, New South Wales, Australia
• Local Institution - 0021 — Tweed Heads, New South Wales, Australia
• Local Institution - 0032 — Joondalup, Western Australia, Australia

Full record on ClinicalTrials.gov

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