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Purpose

The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.

Condition

Eligibility

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

Inclusion Criteria

  • Participants must have a histologically or cytologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) (squamous and nonsquamous) with Stage IIIB/IIIC or Stage IV disease. - Participants must have a programmed death ligand-1 (PD-L1) expression ≥ 50%. - Participants must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. - Participants must have no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC. - Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

Exclusion Criteria

  • Participants must not have any documented actionable genomic alteration (AGA) for which first-line (1L) approved therapies are indicated. - Participants must not have any symptomatic untreated central nervous system (CNS) metastases, leptomeningeal metastases (carcinomatous meningitis) or spinal cord compression. - Participants must not have any significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, or major thrombotic or embolic events or major hemorrhagic events (within 6 months prior to randomization), or significant risk of pulmonary hemorrhage. - Participants must not an active autoimmune disease. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Pumitamig
  • Drug: Pumitamig
    Specified dose on specified days
    Other names:
    • BMS-986545
Active Comparator
Arm B: Pembrolizumab
  • Drug: Pembrolizumab
    Specified dose on specified days

Recruiting Locations

Orange Coast Memorial Medical Center
Fountain Valley, California 92708
Contact:
Amol Rao, Site 0299
510673-1293

Clermont Oncology Center
Clermont, Florida 34711
Contact:
Gopal Kunta, Site 0192
352-242-1366

BRP- Hialeah Hospital
Hialeah, Florida 33013
Contact:
Luis Rangel, Site 0395
833-489-4968

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia 30060
Contact:
Walid Shaib, Site 0284
770-281-5124

Missouri Cancer Associates
Columbia, Missouri 65201
Contact:
Caleb Smith, Site 0350

WellSpan Oncology Research
York, Pennsylvania 17403
Contact:
Ikechukwu Akunyili, Site 0344
717-339-2560

Texas Oncology - San Antonio
San Antonio, Texas 78217
Contact:
Krishna Alluri, Site 0351
210-656-7177

Shenandoah Oncology, P.C.
Winchester, Virginia 22601
Contact:
Michael McCusker Jr., Site 0349

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.