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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)

RecruitingPhase 3

ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 Study of Pumitamig Monotherapy Compared to Durvalumab in Participants With Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy.

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

About the study

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

What is being tested

Sponsor: Bristol-Myers Squibb · Participants: 850 · Started: Mar 16, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07361497

Locations in the U.S.

AlabamaSouthern Cancer Center Pc, Daphne
ColoradoIntermountain Health Cancer Center Lutheran Hospital, Golden
DelawareMedical Oncology Hematology Consultants, PA, Newark
FloridaLocal Institution - 0711, Ocala (Not yet recruiting)
Florida Clinical Trials Group, Tamarac
GeorgiaNorthwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital, Marietta
IllinoisUniversity of Chicago Medical Center, Chicago
Endeavor Health, Evanston
Illinois Cancer Care, Peoria
IndianaFort Wayne Medical Oncology and Hematology, Fort Wayne
KentuckyUniversity of Kentucky Chandler Medical Center, Lexington
MassachusettsLocal Institution - 0603, Boston (Not yet recruiting)
MichiganKarmanos Cancer Institute, Detroit
MinnesotaMinnesota Oncology Hematology, Maple Grove
Allina Health Cancer Institute - Abbott Northwestern Hospital, Minneapolis
MissouriMissouri Cancer Associates, Columbia
New YorkMemorial Sloan Kettering Cancer Center, New York
Optum Medical Care, PC, Westbury
North CarolinaNovant Health Pharmacy Oncology Specialists, Winston-Salem
OhioAkron General Medical Center, Akron
The Christ Hospital, Cincinnati
Cleveland Clinic, Cleveland
University Hospitals Cleveland Medical Center, Cleveland
Cleveland Clinic - Hillcrest Hospital, Mayfield Heights
OregonOncology Associates Of Oregon, Pc, Eugene
Northwest Cancer Specialists, P.C., Happy Valley
TennesseeSCRI Oncology Partners, Nashville
Tennessee Oncology, Nashville
TexasTexas Oncology - Amarillo Cancer Center, Amarillo
Texas Oncology-Austin Central, Austin
Texas Oncology, Denton
The Center For Cancer And Blood Disorders, Fort Worth
The University of Texas-MD Anderson Cancer Center, Houston
Texas Oncology - San Antonio Medical Center, San Antonio
Texas Oncology - Northeast Texas, Tyler
VirginiaBlue Ridge Cancer Care, Christiansburg
Virginia Oncology Associates, Norfolk

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.