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A Study of Pumitamig vs. Pembrolizumab for Advanced Lung Cancer

This study is looking for people with advanced non-small cell lung cancer (NSCLC) that has not been treated before. You might be able to join if your cancer has a high level of a marker called PD-L1 (50% or more). The study is comparing a drug called Pumitamig to Pembrolizumab to see which one works better. Researchers will measure how long people live without their cancer getting worse (progression-free survival) and how long they live overall. The study aims to enroll about 750 participants.

Study design
This interventional study is comparing two drugs, Pumitamig and Pembrolizumab, in about 750 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow participants for up to approximately 3 years to measure progression-free survival and up to approximately 5 years to measure overall survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07361510

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)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~750 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:PumitamigPembrolizumab

At a glance

Recruiting sites
134 of 278 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured over Up to approximately 3 years
+1 more outcome measured

Conditions

Non-Small Cell Lung Cancer (NSCLC)

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Where it's being run

278 sites across 156 states
Turkey (Türkiye)11
California8
France6
Germany6
Romania6
Spain6
Japan5
United Kingdom5

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

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