A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)

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

  • Non-Small Cell Lung Cancer (NSCLC)

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