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Purpose

The purpose of this study is to assess the safety, tolerability, and efficacy of Imzokitug in combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) versus Pumitamig and PDCT as first-line treatment for participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants must have histologically confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) (squamous or non-squamous) or recurrent unresectable disease per the American joint committee on cancer (AJCC) Staging System 9th edition. - Participants must have no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease. - Tumor tissue (fresh or archival) obtained within 5 months of enrollment (signing of informed consent) for each participant must be submitted by the site. - Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1. - Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion Criteria

  • Participants must not have any documented actionable genomic alterations (AGAs) for which first line approved targeted therapies are indicated. - Participants must not have prior treatment with immuno-oncology therapies. - Participants must not have untreated central nervous system (CNS) metastases. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A
  • Drug: Pumitamig
    Specified dose on specified days
    Other names:
    • BMS-986545
    • BNT327
    • PM8002
  • Drug: Imzokitug
    Specified dose on specified days
    Other names:
    • Anti-CCR8
    • BMS-986340
Experimental
Arm B
  • Drug: Pumitamig
    Specified dose on specified days
    Other names:
    • BMS-986545
    • BNT327
    • PM8002
  • Drug: Imzokitug
    Specified dose on specified days
    Other names:
    • Anti-CCR8
    • BMS-986340
Experimental
Arm C
  • Drug: Pumitamig
    Specified dose on specified days
    Other names:
    • BMS-986545
    • BNT327
    • PM8002
  • Drug: Imzokitug
    Specified dose on specified days
    Other names:
    • Anti-CCR8
    • BMS-986340
Experimental
Arm D
  • Drug: Pumitamig
    Specified dose on specified days
    Other names:
    • BMS-986545
    • BNT327
    • PM8002

Recruiting Locations

Nebraska Cancer Specialists
Grand Island, Nebraska 68803
Contact:
Joel Michalski, Site 0172
402-955-2691

Oncology Hematology West PC
Omaha, Nebraska 68130
Contact:
Joel Michalski, Site 0102
402-955-2691

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.