Clinical trial NCT06094296: 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)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: NSCLC
Keywords: Pharmacokinetics
BMS-986315
Nivolumab
Platinum doublet chemotherapy
NSCLC
Lung cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) for Part 1
timeFrame: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
measure: Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 1
timeFrame: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
measure: Number of Participants With Serious Adverse Events (SAEs) for Part 1
timeFrame: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
measure: Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 1
timeFrame: From first dose (Cycle 1 Day 1) up to day 28
measure: Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 1
timeFrame: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
measure: Number of Participants Who Died in Part 1
timeFrame: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
measure: Objective Response Rate (ORR) for Part 2
timeFrame: From randomization until the date of first objectively documented progression or start of subsequent therapy whichever occurred first (planned for up to approximately 5 years)
Secondary outcomes:
measure: Progression Free Survival (PFS) for Part 2
timeFrame: From randomization until the date of first objectively documented progression or death due to any cause, whichever occurred first (planned for up to approximately 5 years)
measure: Number of Participants With Adverse Events (AEs) for Part 2
timeFrame: Up to 100 days after discontinuation of study treatment
measure: Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 2
timeFrame: Up to 100 days after discontinuation of study treatment
measure: Number of Participants With Serious Adverse Events (SAEs) for Part 2
timeFrame: Up to 100 days after discontinuation of study treatment
measure: Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 2
timeFrame: Up to 100 days after discontinuation of study treatment
measure: Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 2
timeFrame: Up to 100 days after discontinuation of study treatment
measure: Number of Participants Who Died in Part 2
timeFrame: Up to 100 days after discontinuation of study treatment
measure: Duration of Response (DoR) for Part 2
timeFrame: From randomization until the date of first objectively documented progression or death due to any cause, whichever occurred first (planned for up to approximately 5 years)
measure: Time to Objective Response (TTR) for Part 2
timeFrame: From randomization until the date of first objectively documented progression or death due to any cause, whichever occurred first (planned for up to approximately 5 years)
measure: Disease Control Rate (DCR) for Part 2
timeFrame: From randomization until the date of first objectively documented progression or death due to any cause, whichever occurred first (planned for up to approximately 5 years)
measure: Maximum Observed Serum Concentration (Cmax) for Part 2
timeFrame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 (Each Cycle is of 21 Days)
measure: Time of Maximum Observed Concentration (Tmax) for Part 2
timeFrame: C1D1, C1D2, C1D4, C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C5D2, C5D4, C5D8, C5D15, Day 1 of every 4 cycles from cycle 6 (up to 2 years); at 30 and 100 days post last dose (Each Cycle is of 21 Days)
measure: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for Part 2
timeFrame: C1D1, C1D2, C1D4, C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C5D2, C5D4, C5D8, C5D15, Day 1 of every 4 cycles from cycle 6 (up to 2 years); at 30 and 100 days post last dose (Each Cycle is of 21 Days)
measure: Number of Participants With Anti-drug Antibodies (ADA) to BMS-986315 for Part 2
timeFrame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Day 1 of every 4 cycles from cycle 6 (up to 2 years); at 30 and 100 days post last dose (Each Cycle is of 21 Days)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Local Institution - 0038
state: California
city: Clermont
country: United States
facility: Local Institution - 0044
state: Florida
city: Orange City
country: United States
facility: Local Institution - 0040
state: Florida
city: Boise
country: United States
facility: Local Institution - 0058
state: Idaho
city: Houston
country: United States
facility: Local Institution - 0049
state: Texas
city: St Leonards
country: Australia
facility: Local Institution - 0013
state: New South Wales
city: Tweed Heads
country: Australia
facility: Local Institution - 0021
state: New South Wales
city: Joondalup
country: Australia
facility: Local Institution - 0032
state: Western Australia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: