Status:
TERMINATED
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)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2024
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT06094296
Start Date
November 27 2023
End Date
August 8 2024
Last Update
April 16 2025
Active Locations (8)
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1
Local Institution - 0038
Glendale, California, United States, 37219
2
Local Institution - 0044
Clermont, Florida, United States, 34711
3
Local Institution - 0040
Orange City, Florida, United States, 32763
4
Local Institution - 0058
Boise, Idaho, United States, 83706