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)
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 30, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Bristol-Myers Squibb
- Interventions being studied
- Drug: Pumitamig; Drug: Durvalumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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/
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Southern Cancer Center PcDaphne, Alabama
- Intermountain Health Cancer Center Lutheran HospitalGolden, Colorado
- Medical Oncology Hematology Consultants, PANewark, Delaware
- Local Institution - 0711Ocala, Florida
- Local Institution - 0935Plantation, Florida
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb HospitalMarietta, Georgia
- University of Chicago Medical CenterChicago, Illinois
- Endeavor HealthEvanston, Illinois
- Illinois Cancer CarePeoria, Illinois
- Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana
- University of Kentucky Chandler Medical CenterLexington, Kentucky
- Local Institution - 0603Boston, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 30, 2026. Always confirm current availability with the study team.