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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) - Trial NCT06094296

Access comprehensive clinical trial information for NCT06094296 through Pure Global AI's free database. This Phase 2 trial is sponsored by Bristol-Myers Squibb and is currently Not yet recruiting. The study focuses on NSCLC. Target enrollment is 196 participants.

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NCT06094296
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06094296
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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)
A Randomized, Double-blind, Phase 2 Study of BMS-986315 and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

Study Focus

NSCLC

BMS-986315

Interventional

drug

Sponsor & Location

Bristol-Myers Squibb

Boise,Rochester,Charleston,Seattle,Cordoba City,Vina Del Mar,Rome,Gdansk,Cluj-Napoca,Cluj-Napoca,Cluj-napoca,Craiova,Floresti, Argentina,Chile,Italy,Poland,Romania,United States of America

Timeline & Enrollment

Phase 2

Nov 03, 2023

Oct 10, 2027

196 participants

Primary Outcome

Part 1: Number of Participants with Adverse Events (AEs),Part 1: Number of Participants with Treatment-related AEs (TRAEs),Part 1: Number of Participants with Serious AEs (SAEs),Part 1: Number of Participants with AEs Meeting Protocol-defined Dose Limiting Toxicity DLT Criteria,Part 1: Number of Participants with AEs Leading to Discontinuation,Part 1: Number of Participants with AEs Leading to Death,Part 2: Objective Response Rate (ORR)

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 in the first-line treatment of Stage IV or recurrent non-small cell
 lung cancer (NSCLC).

Data Source

ClinicalTrials.gov

NCT06094296

Non-Device Trial