Recruiting
Phase 3

Pumitamig vs. Pembrolizumab

Sponsor:

Bristol-Myers Squibb

Code:

NCT07361510

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pumitamig

Pembrolizumab

Study Details

Brief summary:

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%.

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Study ID

NCT07361510

Start date

Mar 12, 2026

Status verified date

Aug, 2026

Completion date

Oct 14, 2031

Anticipated

Primary completion date

Oct 14, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

750 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Pumitamig

active comparator: Arm B: Pembrolizumab

Interventions

Pumitamig

Specified dose on specified days

Pembrolizumab

Specified dose on specified days

Primary outcome measure

  • Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to approximately 3 years ]
  • Overall survival (OS) [ Time Frame: Up to approximately 5 years ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Southern Cancer Center Pc

Recruiting

Daphne, Alabama, United States, 36526

Contacts

Michael Meshad, Site 0348

111-111-1111

Mohtaseb Cancer Center & Blood Disorders

Recruiting

Bullhead City, Arizona, United States, 86442

Palo Verde Hematology Oncology

Recruiting

Glendale, Arizona, United States, 85304

Contacts

Amol Rakkar, Site 0391

602-978-6255

Orange Coast Memorial Medical Center

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Amol Rao, Site 0299

510673-1293

BASS Cancer Center

Recruiting

Walnut Creek, California, United States, 94598

Contacts

Jewel Johl, Site 0416

916-734-3771

Clermont Oncology Center

Recruiting

Clermont, Florida, United States, 34711

Contacts

Gopal Kunta, Site 0192

352-242-1366

Advanced Research

Recruiting

Coral Springs, Florida, United States, 33321

Contacts

Sumit Sawhney, Site 0406

954-302-3120

BRP- Hialeah Hospital

Recruiting

Hialeah, Florida, United States, 33013

Contacts

Luis Rangel, Site 0395

833-489-4968

Florida Clinical Trials Group

Recruiting

Tamarac, Florida, United States, 33321

Contacts

Chintan Gandhi, Site 0434

561-447-0614

University Cancer & Blood Center, LLC

Recruiting

Athens, Georgia, United States, 30607

Contacts

Frederick Flynt Jr, Site 0396

706-353-2990

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Recruiting

Marietta, Georgia, United States, 30060

Contacts

Walid Shaib, Site 0284

770-281-5124

Northwest Cancer Centers, P.C.

Recruiting

Dyer, Indiana, United States, 46311

Contacts

Shruti Singh, Site 0409

219-924-8178

Missouri Cancer Associates

Recruiting

Columbia, Missouri, United States, 65201

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Mark Awad, Site 0026

617-632-3468

Optum Medical Care, PC

Recruiting

Westbury, New York, United States, 11590

Contacts

Jonathan Goldberg, Site 0214

914-242-2991

Lancaster General Hospital

Recruiting

Lancaster, Pennsylvania, United States, 17602

Contacts

Samuel Kerr, Site 0288

717-215-9561

WellSpan Oncology Research

Recruiting

York, Pennsylvania, United States, 17403

Contacts

Ikechukwu Akunyili, Site 0344

717-339-2560

University Of Texas Medical Branch At Galveston

Recruiting

Galveston, Texas, United States, 77555

Contacts

Maurice Willis, Site 0376

409-772-1164

Kelsey-Seybold Clinic Main Campus

Recruiting

Houston, Texas, United States, 77025

Contacts

Sunil Patel, Site 0353

713-442-1700

Texas Oncology - San Antonio

Recruiting

San Antonio, Texas, United States, 78217

Contacts

Krishna Alluri, Site 0351

210-656-7177

Shenandoah Oncology, P.C.

Recruiting

Winchester, Virginia, United States, 22601

HSHS St. Vincent Hospital Regional Cancer Center

Recruiting

Green Bay, Wisconsin, United States, 54301

Contacts

Brian Burnette, Site 0380

920-884-3135

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Non-Small Cell Lung Cancer (NSCLC)
  • 1L NSCLC
  • Programmed death ligand-1 (PD-L1)
  • Frst line NSCLC
  • Advanced NSCLC
  • Metastatic NSCLC
  • Pumitamig
  • Pembrolizumab
  • ROSETTA LUNG-202
  • ROSETTA LUNG
  • CA2660002

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-08-10.