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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
Local Institution - 0027, Los Alamitos (Not yet recruiting)
Local Institution - 0422, Los Angeles (Not yet recruiting)
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
OhioLocal Institution - 0383, Cincinnati (Not yet recruiting)
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
Local Institution - 0421, Marshfield (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.