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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Southern Cancer Center Pc
  Daphne, Alabama, United States Recruiting
• Mohtaseb Cancer Center & Blood Disorders
  Bullhead City, Arizona, United States Recruiting
• Palo Verde Hematology Oncology
  Glendale, Arizona, United States Recruiting
• Beverly Hills Cancer Center
  Beverly Hills, California, United States Recruiting
• Orange Coast Memorial Medical Center
  Fountain Valley, California, United States Recruiting
• Cancer and Blood Specialty Clinic
  Los Alamitos, California, United States Recruiting

+233 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.