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A Phase 2 Study of BMS-986315 and Nivolumab in Combination with Chemotherapy in Participants with First-line Stage IV or Recurrent NSCLC
EU CTIS ID: 2022-503007-22-00
What this study is testing
Part 1: Safety Lead-in Assess the safety of BMS-986315 administered in combination with nivolumab and histology-based platinum doublet chemotherapy (PDCT). Part 2: Primary Compare the anti-tumor activity, specifically the objective response rate (ORR) of BMS-986315 and nivolumab in combination with PDCT versus nivolumab and PDCT.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female participants must be ≥ 18 years of age or local age of majority at the time of signing the informed consent. 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 RECIST v1.1; an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; and a life expectancy of at least 3 months at the time of first dose.
You likely can't join if
- Exclusion Criteria (All Study Parts): Untreated symptomatic central nervous system metastases. Participants with EGFR/ALK/ROS1/NTRK/MET/BRAF/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.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- United States
- Australia
- Chile
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; United States; Australia; Chile; Argentina. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.