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)

NCT06094296 | Terminated Phase 2 Results FDA Drug

• 3 other identifiers: CA047-10092022-503007-22U1111-1282-5699
• Study Type: interventional
• Target: 1
• Locations: 2 countries
• Sites: 8

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).

Conditions

NSCLC

Keywords

Pharmacokinetics; BMS-986315; Nivolumab; Platinum doublet chemotherapy; NSCLC; Lung cancer

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Adverse Events (AEs) for Part 1

  An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.

  From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)

• Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 1

  An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.

  From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)

• Number of Participants With Serious Adverse Events (SAEs) for Part 1

  Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

  From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)

• Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 1

  Dose-Limiting Toxicities (DLTs) are treatment effects serious enough to prevent dose increase. Severity grades: 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death * Grade 2 uveitis or eye pain not improving or require systemic treatment * Grade 2 pneumonitis or interstitial lung disease \>14 days * Grade ≥ 3 uveitis, episcleritis, iritis, pneumonitis, bronchospasm or neurologic toxicity * Grade 3 colitis not responding \>48 hours * Hepatic abnormalities without liver metastases: serum transaminases (AST/ALT) \>5x \& ≤ 8xULN for \>2weeks, AST/ALT \>8xULN regardless of duration, total bilirubin \>3xULN, or concurrent AST/ALT \>3xULN \& total bilirubin \>2xULN * Hepatic abnormalities with liver metastases: AST/ALT \>8x \& ≤10xULN for \>2 weeks, AST/ALT \>10xULN regardless of duration, total bilirubin \> 3xULN, or concurrent AST/ALT \>8xULN \& total bilirubin \>2xULN * Grade 3 (hypersensitivity reaction not resolving to Grade 1 in 6 hours; fatigue \>7 days; nausea, vomiting, or diarrhea \>72 hours)

  From first dose (Cycle 1 Day 1) up to day 28

• Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 1

  An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.

  From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)

• Number of Participants Who Died in Part 1

  Number of participants who died during the study

  From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)

• Objective Response Rate (ORR) for Part 2

  Objective response rate (ORR) is defined as the number of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. No participants were enrolled in Part 2 due to the study termination; therefore, no data were collected for this endpoint.

  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 (14)

• Progression Free Survival (PFS) for Part 2

  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)

• Number of Participants With Adverse Events (AEs) for Part 2

  Up to 100 days after discontinuation of study treatment

• Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 2

  Up to 100 days after discontinuation of study treatment

• Number of Participants With Serious Adverse Events (SAEs) for Part 2

  Up to 100 days after discontinuation of study treatment

• Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 2

  Up to 100 days after discontinuation of study treatment

Study Arms (5)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Part 2: Nivolumab + Histology-based PDCT

ACTIVE COMPARATOR

Drug: Nivolumab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

BMS-986315 DRUG

Specified dose on specified days

Also known as: Anti-NKG2A

Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT; Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT; Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT; Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT

Nivolumab DRUG

Specified dose on specified days

Also known as: Opdivo, BMS-936558

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

Pemetrexed DRUG

Specified dose on specified days

Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT; Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT; Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT; Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT; Part 2: Nivolumab + Histology-based PDCT

Cisplatin DRUG

Specified dose on specified days

Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT; Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT; Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT; Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT; Part 2: Nivolumab + Histology-based PDCT

Carboplatin DRUG

Specified dose on specified days

Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT; Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT; Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT; Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT; Part 2: Nivolumab + Histology-based PDCT

Paclitaxel DRUG

Specified dose on specified days

Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT; Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT; Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT; Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT; Part 2: Nivolumab + Histology-based PDCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (8)

Local Institution - 0038

Glendale, California, 37219, United States

Location

Local Institution - 0044

Clermont, Florida, 34711, United States

Location

Local Institution - 0040

Orange City, Florida, 32763, United States

Location

Local Institution - 0058

Boise, Idaho, 83706, United States

Location

Local Institution - 0049

Houston, Texas, 77090, United States

Location

Local Institution - 0013

St Leonards, New South Wales, 2065, Australia

Location

Local Institution - 0021

Tweed Heads, New South Wales, 2485, Australia

Location

Local Institution - 0032

Joondalup, Western Australia, 6027, Australia

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Nivolumab; Pemetrexed; Cisplatin; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: November 27, 2023
• Primary Completion: August 8, 2024
• Study Completion: August 8, 2024
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (5); AU (3)