A Phase 2 Study of BMS-986315 and Nivolumab in Combination with Chemotherapy in Participants with First-line Stage IV or Recurrent NSCLC

Phase 1

• Conditions: on-small Cell Lung Cancer; MedDRA version: 21.1Level: PTClassification code: 10029522Term: Non-small cell lung cancer stage IV Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10029515Term: Non-small cell lung cancer recurrent Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-503007-22-00
• Lead Sponsor: Bristol-Myers Squibb Services Unlimited Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-15
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified