A Study 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)

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

  • Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
  • Metastatic Non-Small Cell Lung Cancer (NSCLC)

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