A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)
Recruiting now Phase 3 NCT07361497
Run by Bristol-Myers Squibb · for 18 and older · All sexes
What this study is about
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
Who can join (things the study team will check)
✅ You may be able to join if…
- Participants must have a histologically- or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC) with unresectable Stage III disease.
- Participants must have received at least 2 cycles of platinum-based concurrent chemoradiotherapy (a total dose of radiation of at least 54 Gy).
- Participants must have no progressive disease (PD) following treatment with concurrent chemoradiotherapy (CCRT).
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
🚫 You may not be able to join if…
- Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements.
- Participants must not have an active autoimmune disease.
- Participants must not have significant cardiovascular impairment such as uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, major thrombotic or embolic events or major hemorrhagic events within 6 months prior to randomization, or significant risk of pulmonary hemorrhage.
- Participants must not have advanced/clinically significant lung disease (within 6 months prior to randomization) or history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (≥ Grade 2), or current or suspected ILD or pneumonitis.
- Participants must not have any prior anticancer therapy (outside of CCRT) for locally advanced Stage III disease.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Where this trial is running
- Southern Cancer Center Pc, Daphne, Alabama, United States
- Local Institution - 0780, Chandler, Arizona, United States
- Local Institution - 0585, Golden, Colorado, United States
- Medical Oncology Hematology Consultants, PA, Newark, Delaware, United States
- Local Institution - 0711, Ocala, Florida, United States
- Local Institution - 0756, Marietta, Georgia, United States
- Local Institution - 0398, Chicago, Illinois, United States
- Local Institution - 0850, Evanston, Illinois, United States
- Illinois Cancer Care, Peoria, Illinois, United States
- Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
- Local Institution - 0656, Lexington, Kentucky, United States
- Local Institution - 0603, Boston, Massachusetts, United States
+ 243 more sites.
Who to contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07361497.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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