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)
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.
- Non-small Cell Lung Cancer (NSCLC)
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Bristol-Myers Squibb
- Enrolment target
- 850
- Started
- 16 March 2026
- Main results due (estimated)
- 18 September 2030
- Study ends (estimated)
- 13 January 2034
- Allocation
- Randomized
- Design
- Parallel
- Purpose
- Treatment
- Masking
- None
- Sites
- 260 · 12 in India
- First posted
- 23 January 2026
- Registry updated
- 30 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied. Healthy volunteers are not accepted.
Age groups: adult, older adult.
These are the headline rules. Every study has a longer list, and whether you are eligible is decided by the research team at the site, never by this page.
Read the 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.
What this study is about
In the sponsor’s own words, from the registry.
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
Keywords: Pumitamig · Locally advanced · Unresectable · Stage 3 Non-small Cell Lung Cancer (NSCLC) · CA2660001
What participants receive
- Experimental
Arm A
Drug: Pumitamig
- Active comparator
Arm B
Drug: Durvalumab
Interventions
PumitamigDrug
Also known as BMS-986545
Specified dose on specified days
DurvalumabDrug
Specified dose on specified days
What the study measures
Primary outcomes
Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)
Time frame: Up to 3 years
Secondary outcomes
Overall survival (OS)
Time frame: Up to approximately 9 years
PFS by investigator (per RECIST v1.1)
Time frame: Up to 3 years
Objective response (OR) by BICR (per RECIST v1.1)
Time frame: Up to 3 years
Disease control rate (DCR) by BICR (per RECIST v1.1)
Time frame: Up to 3 years
Duration of response (DOR) by BICR (per RECIST v1.1)
Time frame: Up to 3 years
Time to Response (TTR) by BICR (per RECIST v1.1)
Time frame: Up to 3 years
Who is running it
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry
- Responsible party
- The sponsor
- Organisation
- Bristol-Myers Squibb
- Collaborators
- BioNTech SE
- Data monitoring committee
- Yes
- US FDA-regulated drug
- Yes
- US FDA-regulated device
- No
- Sponsor's study ID
- CA266-0001
Bristol-Myers Squibb
Study director
Bristol-Myers Squibb
Study sites(260)
Local Institution - 0840
Eluru, Andhra Pradesh, India
Not yet recruiting
Local Institution - 0927
Goraj, Gujarat, India
Not yet recruiting
Local Institution - 0548
Pūlakkōd, Kerala, India
Not yet recruiting
Local Institution - 0864
Aurangabad, Maharashtra, India
Not yet recruiting
Local Institution - 0660
Mumbai, Maharashtra, India
Not yet recruiting
Local Institution - 0663
Mumbai, Maharashtra, India
Not yet recruiting
Local Institution - 0661
Nagpur, Maharashtra, India
Not yet recruiting
Local Institution - 0664
Dwarka, National Capital Territory of Delhi, India
Not yet recruiting
Local Institution - 0856
New Delhi, National Capital Territory of Delhi, India
Not yet recruiting
Local Institution - 0657
Hyderabad, Telangana, India
Not yet recruiting
Local Institution - 0547
Delhi, India
Not yet recruiting
Local Institution - 0659
Pune, India
Not yet recruiting
Southern Cancer Center Pc
Daphne, Alabama, United States
Recruiting
- Michael Meshad, Site 0898111-111-1111
Intermountain Health Cancer Center Lutheran Hospital
Golden, Colorado, United States
Recruiting
- Karng Log, Site 0585303-403-7333
Medical Oncology Hematology Consultants, PA
Newark, Delaware, United States
Recruiting
- Jamal Misleh, Site 0896302-366-1200
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, United States
Recruiting
- Walid Shaib, Site 0756770-281-5124
University of Chicago Medical Center
Chicago, Illinois, United States
Recruiting
- Everett Vokes, Site 0398773-503-0732
Endeavor Health
Evanston, Illinois, United States
Recruiting
- Dhruv Bansal, Site 0850847-570-2112
Illinois Cancer Care
Peoria, Illinois, United States
Recruiting
- Srinivas Jujjavarapu, Site 0897309-243-3000
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Recruiting
- Ahad Sadiq, Site 0317260-436-0800
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Recruiting
- Zhonglin Hao, Site 0656859-218-6704
Karmanos Cancer Institute
Detroit, Michigan, United States
Recruiting
Minnesota Oncology Hematology
Maple Grove, Minnesota, United States
Recruiting
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Recruiting
- Charlene Fares, Site 0142651-241-7025
Missouri Cancer Associates
Columbia, Missouri, United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
Optum Medical Care, PC
Westbury, New York, United States
Recruiting
- Jonathan Goldberg, Site 0909914-242-2991
Novant Health Pharmacy Oncology Specialists
Winston-Salem, North Carolina, United States
Recruiting
- Garrett Sherwood, Site 0493336-209-0239
Akron General Medical Center
Akron, Ohio, United States
Recruiting
- James Stevenson, Site 0923216-636-6888
The Christ Hospital
Cincinnati, Ohio, United States
Recruiting
- Brittaney-Belle Gordon, Site 0412513-321-4333
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Recruiting
- Matthew Mirsky, Site 0359301-980-8969
Cleveland Clinic
Cleveland, Ohio, United States
Recruiting
- James Stevenson, Site 0597216-636-6888
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, United States
Recruiting
- James Stevenson, Site 0924216-636-6888
Oncology Associates Of Oregon, Pc
Eugene, Oregon, United States
Recruiting
- Bo Wang, Site 0895541-683-5001
Northwest Cancer Specialists, P.C.
Happy Valley, Oregon, United States
Recruiting
- Anthony Van Ho, Site 0302503-885-5411
SCRI Oncology Partners
Nashville, Tennessee, United States
Recruiting
- Melissa Johnson, Site 0240615-329-7274
Tennessee Oncology
Nashville, Tennessee, United States
Recruiting
- Wade Iams, Site 0480615-322-4967
Texas Oncology - Amarillo Cancer Center
Amarillo, Texas, United States
Recruiting
- Pankaj Khandelwal, Site 0908000-000-0000
Texas Oncology-Austin Central
Austin, Texas, United States
Recruiting
- James Uyeki, Site 0857512-427-9400
Texas Oncology
Denton, Texas, United States
Recruiting
- Kartik Konduri, Site 0894214-370-1000
Showing 40 of 260 sites, filter to narrow it down. 192 of 260 on this study are recruiting right now, and 12 are in India. A site can stop enrolling while the study as a whole is still open.
References and data sharing
- Participant data shared
- Yes
- What is shared
- Study protocol, Sap, Csr
- When
- See Plan Description
- Access
- See Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Source: ClinicalTrials.gov record NCT07361497, status verified September 2026. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Interested in this study?
Tell us how to reach you and we will connect you with the study team. Or refer someone you care for, with their permission.