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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)

RecruitingPhase 3

ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥ 50%.

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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%.

What is being tested

Sponsor: Bristol-Myers Squibb · Participants: 750 · Started: Mar 12, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07361510

Locations in the U.S.

AlabamaSouthern Cancer Center Pc, Daphne
ArizonaMohtaseb Cancer Center & Blood Disorders, Bullhead City
Palo Verde Hematology Oncology, Glendale
CaliforniaBeverly Hills Cancer Center, Beverly Hills
Orange Coast Memorial Medical Center, Fountain Valley
Cancer and Blood Specialty Clinic, Los Alamitos
UCLA, Los Angeles
Pacific Cancer Care, Monterey
Local Institution - 0403, Oakland (Not yet recruiting)
Local Institution - 0208, Pleasant Hill (Not yet recruiting)
BASS Cancer Center, Walnut Creek
ColoradoLocal Institution - 0340, Lakewood (Not yet recruiting)
FloridaClermont Oncology Center, Clermont
Advanced Research, Coral Springs
BRP- Hialeah Hospital, Hialeah
Florida Clinical Trials Group, Tamarac
GeorgiaUniversity Cancer & Blood Center, LLC, Athens
Local Institution - 0412, Augusta (Not yet recruiting)
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital, Marietta
IllinoisLocal Institution - 0423, Urbana (Not yet recruiting)
IndianaNorthwest Cancer Centers, P.C., Dyer
MissouriMissouri Cancer Associates, Columbia
New YorkLocal Institution - 0224, Laurelton (Not yet recruiting)
Memorial Sloan Kettering Cancer Center, New York
Optum Medical Care, PC, Westbury
North CarolinaNovant Health Pharmacy Oncology Specialists, Winston-Salem
OhioCincinnati Veterans Affairs Medical Center, Cincinnati
OklahomaLocal Institution - 0418, Oklahoma City (Not yet recruiting)
PennsylvaniaLancaster General Hospital, Lancaster
Local Institution - 0028, Pittsburgh (Not yet recruiting)
WellSpan Oncology Research, York
TexasUniversity Of Texas Medical Branch At Galveston, Galveston
Kelsey-Seybold Clinic Main Campus, Houston
Local Institution - 0381, San Antonio (Not yet recruiting)
Texas Oncology - San Antonio, San Antonio
VirginiaLocal Institution - 0337, Richmond (Not yet recruiting)
Shenandoah Oncology, P.C., Winchester
WashingtonLocal Institution - 0384, Spokane (Not yet recruiting)
West VirginiaCharleston Area Medical Center (CAMC), Charleston
WisconsinHSHS St. Vincent Hospital Regional Cancer Center, Green Bay
Marshfield Medical Center - Marshfield, Marshfield

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.