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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
ArizonaLocal Institution - 0780, Chandler (Not yet recruiting)
ColoradoIntermountain Health Cancer Center Lutheran Hospital, Golden
DelawareMedical Oncology Hematology Consultants, PA, Newark
FloridaLocal Institution - 0711, Ocala (Not yet recruiting)
GeorgiaNorthwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital, Marietta
IllinoisUniversity of Chicago Medical Center, Chicago
Local Institution - 0850, Evanston (Not yet recruiting)
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
Local Institution - 0142, Saint Paul (Not yet recruiting)
MissouriMissouri Cancer Associates, Columbia
New YorkMemorial Sloan Kettering Cancer Center, New York
Optum Medical Care, PC, Westbury
North CarolinaLocal Institution - 0493, Winston-Salem (Not yet recruiting)
OhioLocal Institution - 0923, Akron (Not yet recruiting)
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 Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.