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

Conditions studied: Non-small Cell Lung Cancer (NSCLC)

In brief

A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)

Key facts

Study ID

NCT07361497

Run by

Bristol-Myers Squibb

People needed

850

Starts

2026-03-16

Expected to finish

2033-12-31

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Texas Oncology — Denton, Texas, United States (enrolling)
• Blue Ridge Cancer Care — Christiansburg, Virginia, United States (enrolling)
• Northwest Cancer Specialists, P.C. — Happy Valley, Oregon, United States (enrolling)
• Texas Oncology-Austin Central — Austin, Texas, United States (enrolling)
• Texas Oncology - San Antonio Medical Center — San Antonio, Texas, United States (enrolling)
• Texas Oncology - Northeast Texas — Tyler, Texas, United States (enrolling)
• Medical Oncology Hematology Consultants, PA — Newark, Delaware, United States (enrolling)
• Oncology Associates Of Oregon, Pc — Eugene, Oregon, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Texas Oncology - Amarillo Cancer Center — Amarillo, Texas, United States (enrolling)
• The University of Texas-MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• Minnesota Oncology Hematology — Maple Grove, Minnesota, United States (enrolling)
• Intermountain Health Cancer Center Lutheran Hospital — Golden, Colorado, United States (enrolling)
• Missouri Cancer Associates — Columbia, Missouri, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Illinois Cancer Care — Peoria, Illinois, United States (enrolling)
• Optum Medical Care, PC — Westbury, New York, United States (enrolling)
• Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States (enrolling)
• Southern Cancer Center Pc — Daphne, Alabama, United States (enrolling)
• University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States (enrolling)
• Tennessee Oncology — Nashville, Tennessee, United States (enrolling)
• Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital — Marietta, Georgia, United States (enrolling)
• The Center For Cancer And Blood Disorders — Fort Worth, Texas, United States (enrolling)
• Virginia Oncology Associates — Norfolk, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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