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)
NCT ID: NCT06094296
Last Updated: 2025-04-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2023-11-27
2024-08-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT
BMS-986315
Specified dose on specified days
Pemetrexed
Specified dose on specified days
Cisplatin
Specified dose on specified days
Carboplatin
Specified dose on specified days
Paclitaxel
Specified dose on specified days
Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT
BMS-986315
Specified dose on specified days
Pemetrexed
Specified dose on specified days
Cisplatin
Specified dose on specified days
Carboplatin
Specified dose on specified days
Paclitaxel
Specified dose on specified days
Part 2: Nivolumab + Histology-based PDCT
Nivolumab
Specified dose on specified days
Pemetrexed
Specified dose on specified days
Cisplatin
Specified dose on specified days
Carboplatin
Specified dose on specified days
Paclitaxel
Specified dose on specified days
Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT
BMS-986315
Specified dose on specified days
Nivolumab
Specified dose on specified days
Pemetrexed
Specified dose on specified days
Cisplatin
Specified dose on specified days
Carboplatin
Specified dose on specified days
Paclitaxel
Specified dose on specified days
Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT
BMS-986315
Specified dose on specified days
Nivolumab
Specified dose on specified days
Pemetrexed
Specified dose on specified days
Cisplatin
Specified dose on specified days
Carboplatin
Specified dose on specified days
Paclitaxel
Specified dose on specified days
Interventions
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BMS-986315
Specified dose on specified days
Nivolumab
Specified dose on specified days
Pemetrexed
Specified dose on specified days
Cisplatin
Specified dose on specified days
Carboplatin
Specified dose on specified days
Paclitaxel
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0038
Glendale, California, United States
Local Institution - 0044
Clermont, Florida, United States
Local Institution - 0040
Orange City, Florida, United States
Local Institution - 0058
Boise, Idaho, United States
Local Institution - 0049
Houston, Texas, United States
Local Institution - 0013
St Leonards, New South Wales, Australia
Local Institution - 0021
Tweed Heads, New South Wales, Australia
Local Institution - 0032
Joondalup, Western Australia, Australia
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2022-503007-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1282-5699
Identifier Type: OTHER
Identifier Source: secondary_id
CA047-1009
Identifier Type: -
Identifier Source: org_study_id
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