NSCLC Clinical Trial
Official title:
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)
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).
| Status | Recruiting |
| Enrollment | 196 |
| Est. completion date | October 27, 2027 |
| Est. primary completion date | October 10, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0020 | Buenos Aires | |
| Argentina | Local Institution - 0022 | Cordoba City | Provincia De Cordoba |
| Argentina | Local Institution - 0001 | Rio Cuarto | Cordoba |
| Argentina | Local Institution - 0002 | Viedma | Rio Negro |
| Australia | Local Institution - 0032 | Joondalup | Western Australia |
| Australia | Local Institution - 0013 | St Leonards | New South Wales |
| Australia | Local Institution - 0021 | Tweed Heads | New South Wales |
| Chile | Local Institution - 0043 | Vina Del Mar | Valparaiso |
| France | Local Institution - 0054 | Paris Cedex 05 | Ile De France |
| Italy | Local Institution - 0009 | Parma | |
| Italy | Local Institution - 0006 | Rome | |
| Poland | Local Institution - 0015 | Gdansk | Pomorskie |
| Poland | Local Institution - 0056 | Krakow | Malopolskie |
| Romania | Local Institution - 0060 | Cluj-napoca | |
| Romania | Local Institution - 0062 | Cluj-Napoca | |
| Romania | Local Institution - 0066 | Cluj-Napoca | Cluj |
| Romania | Local Institution - 0061 | Craiova | |
| Romania | Local Institution - 0065 | Floresti | |
| Spain | Local Institution - 0027 | Madrid | |
| United States | Local Institution - 0041 | Baltimore | Maryland |
| United States | Saint Alphonsus Regional Medical Center | Boise | Idaho |
| United States | The Medical University of South Carolina | Charleston | South Carolina |
| United States | Clermont Oncology Center | Clermont | Florida |
| United States | Los Angeles Cancer Research | Glendale | California |
| United States | Millennium Research & Clinical Development | Houston | Texas |
| United States | Mid Florida Hematology and Oncology Center | Orange City | Florida |
| United States | MAYO | Rochester | Minnesota |
| United States | Swedish Cancer Institute | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Australia, Chile, France, Italy, Poland, Romania, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Part 1: Number of Participants with Adverse Events (AEs) | Up to 100 days after discontinuation of study treatment | ||
| Primary | Part 1: Number of Participants with Treatment-related AEs (TRAEs) | Up to 100 days after discontinuation of study treatment | ||
| Primary | Part 1: Number of Participants with Serious AEs (SAEs) | Up to 100 days after discontinuation of study treatment | ||
| Primary | Part 1: Number of Participants with AEs Meeting Protocol-defined Dose Limiting Toxicity DLT Criteria | Up to 100 days after discontinuation of study treatment | ||
| Primary | Part 1: Number of Participants with AEs Leading to Discontinuation | Up to 100 days after discontinuation of study treatment | ||
| Primary | Part 1: Number of Participants with AEs Leading to Death | Up to 100 days after discontinuation of study treatment | ||
| Primary | Part 2: Objective Response Rate (ORR) | Up to 5 years | ||
| Secondary | Part 2: Progression Free Survival (PFS) | Up to 5 years | ||
| Secondary | Part 2: Number of Participants with AEs | Up to 100 days after discontinuation of study treatment | ||
| Secondary | Part 2: Number of Participants with TRAEs | Up to 100 days after discontinuation of study treatment | ||
| Secondary | Part 2: Number of Participants with SAEs | Up to 100 days after discontinuation of study treatment | ||
| Secondary | Part 2: Number of Participants with AEs Meeting Protocol-defined Dose Limiting Toxicity DLT Criteria | Up to 100 days after discontinuation of study treatment | ||
| Secondary | Part 2: Duration of Response (DOR) | Up to 5 years | ||
| Secondary | Part 2: Time to Response (TTR) | Up to 5 years | ||
| Secondary | Part 2: Disease Control Rate (DCR) | Up to 5 years | ||
| Secondary | Part 2: Maximum Observed Serum Concentration (Cmax) | Predose and postdose up to 2 years | ||
| Secondary | Part 2: Time of Cmax (Tmax) | Predose and postdose up to 2 years | ||
| Secondary | Part 2: Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T]) | Predose and postdose up to 2 years | ||
| Secondary | Part 2: Number of Participants with Anti-drug Antibodies to BMS-986315 | Up to 5 years |
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