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)

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: NSCLC

Treatments: Drug: Pemetrexed; Drug: Nivolumab; Drug: Carboplatin; Drug: Cisplatin; Drug: BMS-986315; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT06094296

CA047-1009

U1111-1282-5699 (Other Identifier)

2022-503007-22 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1 participants in 5 patient groups

Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT

Experimental group

Treatment:

Drug: Paclitaxel

Drug: BMS-986315

Drug: Cisplatin

Drug: Carboplatin

Drug: Pemetrexed

Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT

Experimental group

Treatment:

Drug: Paclitaxel

Drug: BMS-986315

Drug: Cisplatin

Drug: Carboplatin

Drug: Pemetrexed

Part 2: Nivolumab + Histology-based PDCT

Active Comparator group

Treatment:

Drug: Paclitaxel

Drug: Cisplatin

Drug: Carboplatin

Drug: Pemetrexed

Drug: Nivolumab

Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT

Experimental group

Treatment:

Drug: Paclitaxel

Drug: BMS-986315

Drug: Cisplatin

Drug: Carboplatin

Drug: Pemetrexed

Drug: Nivolumab

Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT

Experimental group

Treatment:

Drug: Paclitaxel

Drug: BMS-986315

Drug: Cisplatin

Drug: Carboplatin

Drug: Pemetrexed

Drug: Nivolumab