A Phase 2 Study of BMS-986315 and Nivolumab in Combination with Chemotherapy in Participants with First-line Stage IV or Recurrent NSCLC
Key facts
- Where
- Badalona, Barcelona, L'Hospitalet de Llobregat, Madrid, Málaga és Zaragoza, SpanyolországSee the 6 sites
- Phase
- 2. fázis
Where in Spanyolország
- Institut Catala d'OncologiaBadalona, SpanyolországNo longer taking part
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországNo longer taking part
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpanyolországNo longer taking part
- Hospital Universitario Fundación Jiménez DíazMadrid, SpanyolországNo longer taking part
- Hospital Universitario Regional de MálagaMálaga, SpanyolországNo longer taking part
- Hospital Clinico Universitario Lozano BlesaZaragoza, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb Services Unlimited Company
- Trial code
- EU 2022-503007-22-00
- Record updated
- 2024. február 1.
- Original description
Part 1: Safety Lead-in Assess the safety of BMS-986315 administered in combination with nivolumab and histology-based platinum doublet chemotherapy (PDCT).Read full original descriptionShow less
A Randomized, Double-Blind, Phase II 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)
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.
Inclusion: 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.