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Pumitamig vs pembrolizumab for first-line advanced NSCLC with PD‑L1 ≥50% (ROSETTA Lung-202)

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%.

PHASE3 · Bristol-Myers Squibb · NCT07361510

This will test if pumitamig works better than pembrolizumab as the first treatment for people with advanced non-small cell lung cancer and PD‑L1 levels of 50% or higher.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment750 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb (industry)
Drugs / interventionsPembrolizumab
Locations272 sites (Daphne, Alabama and 271 other locations)
Trial IDNCT07361510 on ClinicalTrials.gov

What this trial studies

ROSETTA Lung-202 is a randomized Phase 3 trial comparing the investigational drug pumitamig against the approved immunotherapy pembrolizumab in adults with previously untreated stage IIIB/IIIC or IV non-small cell lung cancer and tumor PD‑L1 ≥50%. Eligible participants must have measurable disease by RECIST v1.1 and an ECOG performance status of 0–1, and those with actionable genomic alterations or symptomatic untreated CNS metastases are excluded. Patients are assigned to one of two treatment arms and followed with regular clinic visits, imaging, and safety monitoring to measure outcomes such as progression-free survival, overall survival, and adverse events. The study is sponsored by Bristol-Myers Squibb with collaboration from BioNTech and is being conducted at listed clinical sites in the United States.

Who should consider this trial

Good fit: Ideal candidates are adults with previously untreated stage IIIB/IIIC or IV NSCLC, PD‑L1 tumor expression ≥50%, measurable disease, ECOG 0–1, and no actionable genomic alterations requiring targeted therapy.

Not a fit: Patients with approved first-line targeted therapy options for actionable genomic alterations, symptomatic untreated CNS metastases, prior systemic therapy for advanced disease, or ECOG >1 are unlikely to benefit from joining this trial.

Why it matters

Potential benefit: If successful, pumitamig could offer a more effective first-line option than pembrolizumab for patients with high PD‑L1 expression, potentially improving time without disease progression or overall survival.

How similar studies have performed: Pembrolizumab is an established first-line therapy for PD‑L1 ≥50% NSCLC and other investigational immune therapies have shown both comparable and occasionally improved outcomes in head-to-head comparisons, while pumitamig is a newer investigational agent being tested directly against pembrolizumab.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Daphne, Alabama and 271 other locations

+222 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Non-Small Cell Lung Cancer, 1L NSCLC, Programmed death ligand-1, Frst line NSCLC, Advanced NSCLC, Metastatic NSCLC, Pumitamig, Pembrolizumab

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.