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

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-27

Study Completion Date

2024-08-08

Brief Summary

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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).

Detailed Description

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Conditions

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NSCLC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Group Type EXPERIMENTAL

BMS-986315

Intervention Type DRUG

Specified dose on specified days

Pemetrexed

Intervention Type DRUG

Specified dose on specified days

Cisplatin

Intervention Type DRUG

Specified dose on specified days

Carboplatin

Intervention Type DRUG

Specified dose on specified days

Paclitaxel

Intervention Type DRUG

Specified dose on specified days

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

Group Type EXPERIMENTAL

BMS-986315

Intervention Type DRUG

Specified dose on specified days

Pemetrexed

Intervention Type DRUG

Specified dose on specified days

Cisplatin

Intervention Type DRUG

Specified dose on specified days

Carboplatin

Intervention Type DRUG

Specified dose on specified days

Paclitaxel

Intervention Type DRUG

Specified dose on specified days

Part 2: Nivolumab + Histology-based PDCT

Group Type ACTIVE_COMPARATOR

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Pemetrexed

Intervention Type DRUG

Specified dose on specified days

Cisplatin

Intervention Type DRUG

Specified dose on specified days

Carboplatin

Intervention Type DRUG

Specified dose on specified days

Paclitaxel

Intervention Type DRUG

Specified dose on specified days

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

Group Type EXPERIMENTAL

BMS-986315

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Pemetrexed

Intervention Type DRUG

Specified dose on specified days

Cisplatin

Intervention Type DRUG

Specified dose on specified days

Carboplatin

Intervention Type DRUG

Specified dose on specified days

Paclitaxel

Intervention Type DRUG

Specified dose on specified days

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

Group Type EXPERIMENTAL

BMS-986315

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Pemetrexed

Intervention Type DRUG

Specified dose on specified days

Cisplatin

Intervention Type DRUG

Specified dose on specified days

Carboplatin

Intervention Type DRUG

Specified dose on specified days

Paclitaxel

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986315

Specified dose on specified days

Intervention Type DRUG

Nivolumab

Specified dose on specified days

Intervention Type DRUG

Pemetrexed

Specified dose on specified days

Intervention Type DRUG

Cisplatin

Specified dose on specified days

Intervention Type DRUG

Carboplatin

Specified dose on specified days

Intervention Type DRUG

Paclitaxel

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Anti-NKG2A Opdivo BMS-936558

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Local Institution - 0044

Clermont, Florida, United States

Site Status

Local Institution - 0040

Orange City, Florida, United States

Site Status

Local Institution - 0058

Boise, Idaho, United States

Site Status

Local Institution - 0049

Houston, Texas, United States

Site Status

Local Institution - 0013

St Leonards, New South Wales, Australia

Site Status

Local Institution - 0021

Tweed Heads, New South Wales, Australia

Site Status

Local Institution - 0032

Joondalup, Western Australia, Australia

Site Status

Countries

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United States Australia

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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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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