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)

Last updated: March 27, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Terminated

Phase

2

Condition

Non-small Cell Lung Cancer

Treatment

Nivolumab

Pemetrexed

Cisplatin

Clinical Study ID

NCT06094296
CA047-1009
2022-503007-22
U1111-1282-5699
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Participants must have NSCLC with Stage IV or recurrent disease following multimodaltherapy 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

Exclusion Criteria:

  • Untreated symptomatic central nervous system metastases

  • Participants with epidermal growth factor receptor (EGFR)/ALK receptor tyrosinekinase (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 drugadministration or interfere with the interpretation of safety results

Note: Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Total Participants: 1
Treatment Group(s): 6
Primary Treatment: Nivolumab
Phase: 2
Study Start date:
November 27, 2023
Estimated Completion Date:
August 08, 2024

Connect with a study center

  • Local Institution - 0001

    Rio Cuarto, Cordoba 5800
    Argentina

    Site Not Available

  • Local Institution - 0022

    Cordoba City, Provincia De Cordoba X5004FHP
    Argentina

    Site Not Available

  • Local Institution - 0002

    Viedma, Rio Negro 8500
    Argentina

    Site Not Available

  • Local Institution - 0020

    Buenos Aires, 11 99
    Argentina

    Site Not Available

  • Local Institution - 0013

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Local Institution - 0021

    Tweed Heads, New South Wales 2485
    Australia

    Site Not Available

  • Local Institution - 0032

    Joondalup, Western Australia 6027
    Australia

    Site Not Available

  • Local Institution - 0043

    Vina Del Mar, Valparaiso 252 0598
    Chile

    Site Not Available

  • Local Institution - 0054

    Paris Cedex 05, Ile De France 75005
    France

    Site Not Available

  • Local Institution - 0009

    Parma, 43125
    Italy

    Site Not Available

  • Local Institution - 0006

    Rome, 00128
    Italy

    Site Not Available

  • Local Institution - 0056

    Krakow, Malopolskie 31-826
    Poland

    Site Not Available

  • Local Institution - 0015

    Gdansk, Pomorskie 80-952
    Poland

    Site Not Available

  • Local Institution - 0066

    Cluj-Napoca, Cluj 400132
    Romania

    Site Not Available

  • Local Institution - 0062

    Cluj-Napoca, 400015
    Romania

    Site Not Available

  • Local Institution - 0060

    Cluj-napoca, 400641
    Romania

    Site Not Available

  • Local Institution - 0061

    Craiova, 200347
    Romania

    Site Not Available

  • Local Institution - 0065

    Floresti, 407280
    Romania

    Site Not Available

  • Local Institution - 0027

    Madrid, 28040
    Spain

    Site Not Available

  • Local Institution - 0038

    Glendale, California 37219
    United States

    Site Not Available

  • Los Angeles Cancer Research

    Glendale, California 37219
    United States

    Active - Recruiting

  • Clermont Oncology Center

    Clermont, Florida 34711
    United States

    Active - Recruiting

  • Local Institution - 0044

    Clermont, Florida 34711
    United States

    Site Not Available

  • Local Institution - 0040

    Orange City, Florida 32763
    United States

    Site Not Available

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida 32763
    United States

    Active - Recruiting

  • Local Institution - 0058

    Boise, Idaho 83706
    United States

    Site Not Available

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho 83706
    United States

    Active - Recruiting

  • Local Institution - 0041

    Baltimore, Maryland 21201-1544
    United States

    Site Not Available

  • MAYO

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • The Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Local Institution - 0049

    Houston, Texas 77090
    United States

    Site Not Available

  • Millennium Research & Clinical Development

    Houston, Texas 77090
    United States

    Active - Recruiting

  • Swedish Cancer Institute

    Seattle, Washington 98275
    United States

    Site Not Available

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