RecruitingNCT07361497Updated Sep 30, 2026

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 Phase 3 interventional study of Pumitamig and Durvalumab in Non-small Cell Lung Cancer (NSCLC), sponsored by Bristol-Myers Squibb. Recruiting at 260 sites in 32 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 850
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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

Conditions studied

Non-small Cell Lung Cancer (NSCLC)

Browse trials for

Carcinoma, Non-Small-Cell Lung 6,479

Keywords

Pumitamig
Locally advanced
Unresectable
Stage 3 Non-small Cell Lung Cancer (NSCLC)
CA2660001

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 850 participants (estimated)

Study arms

Experimental
Arm A
Drug: Pumitamig
Active comparator
Arm B
Drug: Durvalumab

Interventions

DrugPumitamig
Specified dose on specified days
Also known as: BMS-986545
DrugDurvalumab
Specified dose on specified days

What researchers measure

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

Study locations

192 of 260 sites recruiting

Southern Cancer Center Pc
Daphne, Alabama 36526, United States
- Michael Meshad, Site 0898 · Contact · 111-111-1111
Recruiting
Intermountain Health Cancer Center Lutheran Hospital
Golden, Colorado 80401, United States
- Karng Log, Site 0585 · Contact · 303-403-7333
Recruiting
Medical Oncology Hematology Consultants, PA
Newark, Delaware 19713, United States
- Jamal Misleh, Site 0896 · Contact · 302-366-1200
Recruiting
Local Institution - 0711
Ocala, Florida 34474, United States
- Site 0711 · Contact
Not yet recruiting
Local Institution - 0935
Plantation, Florida 33322, United States
- Site 0935 · Contact
Not yet recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia 30060, United States
- Walid Shaib, Site 0756 · Contact · 770-281-5124
Recruiting
University of Chicago Medical Center
Chicago, Illinois 60637, United States
- Everett Vokes, Site 0398 · Contact · 773-503-0732
Recruiting
Endeavor Health
Evanston, Illinois 60201, United States
- Dhruv Bansal, Site 0850 · Contact · 847-570-2112
Recruiting
Illinois Cancer Care
Peoria, Illinois 61615, United States
- Srinivas Jujjavarapu, Site 0897 · Contact · 309-243-3000
Recruiting
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46804, United States
- Ahad Sadiq, Site 0317 · Contact · 260-436-0800
Recruiting
University of Kentucky Chandler Medical Center
Lexington, Kentucky 40536, United States
- Zhonglin Hao, Site 0656 · Contact · 859-218-6704
Recruiting
Local Institution - 0603
Boston, Massachusetts 02114-2621, United States
- Site 0603 · Contact
Not yet recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201, United States
- Khalil Choucair, Site 0419 · Contact
Recruiting
Minnesota Oncology Hematology
Maple Grove, Minnesota 55369, United States
- Daniel Mundt, Site 0322 · Contact
Recruiting
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota 55407, United States
- Charlene Fares, Site 0142 · Contact · 651-241-7025
Recruiting
Missouri Cancer Associates
Columbia, Missouri 65201, United States
- Caleb Smith, Site 0900 · Contact
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065, United States
- Mark Awad, Site 0606 · Contact
Recruiting
Local Institution - 0339
Westbury, New York 11590, United States
Withdrawn
Optum Medical Care, PC
Westbury, New York 11590, United States
- Jonathan Goldberg, Site 0909 · Contact · 914-242-2991
Recruiting
Novant Health Pharmacy Oncology Specialists
Winston-Salem, North Carolina 27103, United States
- Garrett Sherwood, Site 0493 · Contact · 336-209-0239
Recruiting
Akron General Medical Center
Akron, Ohio 44302, United States
- James Stevenson, Site 0923 · Contact · 216-636-6888
Recruiting
The Christ Hospital
Cincinnati, Ohio 45219, United States
- Brittaney-Belle Gordon, Site 0412 · Contact · 513-321-4333
Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106, United States
- Matthew Mirsky, Site 0359 · Contact · 301-980-8969
Recruiting
Cleveland Clinic
Cleveland, Ohio 44195, United States
- James Stevenson, Site 0597 · Contact · 216-636-6888
Recruiting
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio 44124, United States
- James Stevenson, Site 0924 · Contact · 216-636-6888
Recruiting
Oncology Associates Of Oregon, Pc
Eugene, Oregon 97401, United States
- Bo Wang, Site 0895 · Contact · 541-683-5001
Recruiting
Northwest Cancer Specialists, P.C.
Happy Valley, Oregon 97015, United States
- Anthony Van Ho, Site 0302 · Contact · 503-885-5411
Recruiting
SCRI Oncology Partners
Nashville, Tennessee 37203, United States
- Melissa Johnson, Site 0240 · Contact · 615-329-7274
Recruiting
Tennessee Oncology
Nashville, Tennessee 37203, United States
- Wade Iams, Site 0480 · Contact · 615-322-4967
Recruiting
Texas Oncology - Amarillo Cancer Center
Amarillo, Texas 79124, United States
- Pankaj Khandelwal, Site 0908 · Contact · 000-000-0000
Recruiting
Texas Oncology-Austin Central
Austin, Texas 78731, United States
- James Uyeki, Site 0857 · Contact · 512-427-9400
Recruiting
Texas Oncology
Denton, Texas 76210, United States
- Kartik Konduri, Site 0894 · Contact · 214-370-1000
Recruiting
The Center For Cancer And Blood Disorders
Fort Worth, Texas 76104, United States
- Ray Page, Site 0811 · Contact · 817-759-7000
Recruiting
The University of Texas-MD Anderson Cancer Center
Houston, Texas 77030, United States
- Tina Cascone, Site 0596 · Contact · 713-792-6363
Recruiting
Texas Oncology - San Antonio Medical Center
San Antonio, Texas 78229, United States
- Krishna Alluri, Site 0902 · Contact · 210-656-7177
Recruiting
Texas Oncology - Northeast Texas
Tyler, Texas 75702, United States
- Sarah Wang, Site 0899 · Contact · 903-579-9800
Recruiting
Blue Ridge Cancer Care
Christiansburg, Virginia 24073, United States
- Jerome Goldschmidt, Site 0133 · Contact · 540-381-5291
Recruiting
Virginia Oncology Associates
Norfolk, Virginia 23502, United States
- John Paschold, Site 0250 · Contact
Recruiting
Instituto Argentino De Diagnostico Y Tratamiento IADT
Buenas Aires, Buenos Aires C1049AAG, Argentina
- Juan Cundom, Site 0093 · Contact · (+54911)4162-5353
Recruiting
Investigaciones Oncologicas C Colon SA
Mar del Plata, Buenos Aires 7600, Argentina
- Ignacio Casarini, Site 0082 · Contact · +5492235937663
Recruiting
Hospital Privado Universitario de Córdoba
Córdoba, Córdoba Province 5016, Argentina
- Jeremias Sierra, Site 0313 · Contact · 543514862400
Recruiting
Sanatorio Parque Rosario
Rosario, Santa Fe Province 2000, Argentina
- Gaston Martinengo, Site 0097 · Contact · 5493416955611
Recruiting
Instituto Medico Especializado Alexander Fleming
Buenos Aires, 1426, Argentina
- Claudio Martin, Site 0094 · Contact · +541132218900
Recruiting
Clinica Adventista Belgrano
Buenos Aires, 1430, Argentina
- Aldo Perfetti, Site 0078 · Contact · 5491132682903
Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB, Argentina
- Yamila Ferreira, Site 0761 · Contact · 11-49590200ext8159
Recruiting
Instituto de Investigaciones Clínicas Córdoba S.A.
Córdoba, X5000, Argentina
- Nicolas Castagneris, Site 0608 · Contact · 549351368119
Recruiting
Gosford Hospital
Gosford, New South Wales 2250, Australia
- Matthew Chan, Site 0456 · Contact · +61243209890
Recruiting
Nepean Hospital
Penrith, New South Wales 2750, Australia
- Deme Karikios, Site 0446 · Contact · (02) 4734 1751
Recruiting
Westmead Hospital
Westmead, New South Wales 2145, Australia
- Adnan Nagrial, Site 0451 · Contact · 0288905200
Recruiting
Lyell McEwin Hospital
Elizabeth Vale, South Australia 5112, Australia
- Joanne Tang, Site 0448 · Contact · 08 7117 7265
Recruiting
Grampians Health
Ballarat Central, Victoria 3350, Australia
- Wasek Faisal, Site 0442 · Contact · 61(03)53208500
Recruiting
Northern Hospital
Epping, Victoria 3076, Australia
- Vishal Boolell, Site 0458 · Contact · (03) 9485 9068
Recruiting
Joondalup Health Campus
Joondalup, Western Australia 6027, Australia
- Arman Hasani, Site 0476 · Contact · +61 8 9400 9897
Recruiting
Universitätsklinik Innsbruck
Innsbruck, 6020, Austria
- Andreas Pircher, Site 0190 · Contact · 4351250483584
Recruiting
Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020, Austria
- Dominik Maurer, Site 0192 · Contact · 4373276764414
Recruiting
Medizinische Universitaet Wien/AKH
Vienna, 1090, Austria
- Thorsten Fuereder, Site 0207 · Contact · 4314040044450
Recruiting
Local Institution - 0122
Anderlecht, Bruxelles-Capitale, Région de 1070, Belgium
- Site 0122 · Contact
Not yet recruiting
Grand Hôpital de Charleroi
Charleroi, Hainaut 6060, Belgium
- Benoit Colinet, Site 0111 · Contact · +32.60.11.90.73
Recruiting
Ziekenhuis Oost-Limburg, Campus St.-Jan
Genk, Limburg 3600, Belgium
- Maarten Criel, Site 0714 · Contact · +3289808260
Recruiting
UZ Gent
Ghent, Oost-Vlaanderen 9000, Belgium
- Veerle Surmont, Site 0120 · Contact · 32933229500
Recruiting
VITAZ
Sint-Niklaas, Oost-Vlaanderen B-9100, Belgium
- Koenraad Deschepper, Site 0117 · Contact · 3237602327
Recruiting
UZ Leuven
Leuven, Vlaams-Brabant 3000, Belgium
- christophe Dooms, Site 0116 · Contact · 003216340961
Recruiting
Algemeen Ziekenhuis klina
Brasschaat, 2930, Belgium
- Vincent Geldhof, Site 0906 · Contact · +3234368061
Recruiting
Vencer Centro de Pesquisa LTDA
Teresina, Piauí 64049-200, Brazil
- CLAUDIO ROCHA, Site 0615 · Contact · 5586999007799
Recruiting
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte 59062-000, Brazil
- Joilda Rego, Site 0498 · Contact · 558440095595
Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul 90035-903, Brazil
- Tiago Heinen, Site 0619 · Contact · 555133598619
Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo 14784400, Brazil
- Josiane Dias, Site 0535 · Contact · 17996782301
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo 15090-000, Brazil
- JOÃO SOLER, Site 0538 · Contact · 551732015054
Recruiting
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000, Brazil
- Fernanda Fujiki, Site 0912 · Contact · +551138932615
Recruiting
Multiprofile Hospital for Active Treatment - Haskovo AD
Haskovo, 6304, Bulgaria
- Stoil Boychev, Site 0736 · Contact · +359889214157
Recruiting
Complex Oncology Center - Ruse EOOD
Rousse, 7002, Bulgaria
- Nikolay Nikolaev, Site 0551 · Contact · 0887098616
Recruiting
"Sveta Ekaterina" Hospital
Sofia, 1431, Bulgaria
- Galina Kurteva, Site 0826 · Contact · +359887623916
Recruiting
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
Sofia, 1527, Bulgaria
- Kremena Vasileva, Site 0732 · Contact
Recruiting
Diagnostic and Consultative Center Convex
Sofia, 1680, Bulgaria
- Petya Balikova, Site 0838 · Contact · +359 893582321
Recruiting
The Ottawa Hospital - General Campus
Ottawa, Ontario K1H 8L6, Canada
- Paul Wheatley-Price, Site 0337 · Contact · 613737770070175
Recruiting
St. Marys Hospital Center
Montreal, Quebec H3T 1M5, Canada
- Adrian Langleben, Site 0644 · Contact · 514-345-3511-3793
Recruiting
IUCPQ
Québec, G1V 4G5, Canada
- Maude Dubé-Pelletier, Site 0682 · Contact · 418-656-8711
Recruiting
Bradford Hill Norte
Antofagasta, AN 1240000, Chile
- Angela Estay, Site 0910 · Contact · 56994198125
Recruiting
Centro de Oncología de Precisión
Las Condes, Arica y Parinacota Region 7560908, Chile
- Pamela Salman Boghikian, Site 0855 · Contact
Recruiting
FALP
Santiago, Santiago Metropolitan 7500921, Chile
- Christian Caglevic, Site 0478 · Contact · 56224457254
Recruiting
Bradfordhill
Santiago, Santiago Metropolitan 8420383, Chile
- Carlos Rojas, Site 0077 · Contact · +56998744662
Recruiting
Oncocentro APYS - Centro de Atencion Medica Oncologica Integral
Viña del Mar, Valparaiso 2520612, Chile
- Alejandro Acevedo Gaete, Site 0328 · Contact · +56992369820
Recruiting
Beijing Cancer hospital
Beijing, Beijing Municipality 100142, China
- Anhui Shi, Site 0754 · Contact · 8613901136511
Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality 400030, China
- Wei Zhou, Site 0308 · Contact · 13883465672
Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian 350014, China
- Haishan Wu, Site 0245 · Contact · 8613696834132
Recruiting
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong 515041, China
- Wen Lin, Site 0298 · Contact · 13612388011
Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong 518036, China
- Yajie Liu, Site 0919 · Contact · 13823394075
Recruiting
Local Institution - 0249
Zhengzhou, Henan 450008, China
- Site 0249 · Contact
Not yet recruiting
Jingzhou First People's Hospital
Jingzhou, Hubei 0, China
- Yonghua Yang, Site 0911 · Contact · 8618163137331
Recruiting
The Central Hospital of Wuhan
Wuhan, Hubei 430014, China
- Hongda Lu, Site 0921 · Contact
Recruiting
Local Institution - 0813
Wuhan, Hubei 430030, China
Withdrawn
Local Institution - 0489
Changsha, Hunan 410031, China
- Site 0489 · Contact
Not yet recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215006, China
- Songbing Qin, Site 0918 · Contact · 13771975906
Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330006, China
- Anwen Liu, Site 0254 · Contact · 8613767120022
Recruiting
Local Institution - 0242
Shenyang, Liaoning 110042, China
- Site 0242 · Contact
Not yet recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi 710004, China
- Hui Guo, Site 0527 · Contact · 8613572824106
Recruiting
Local Institution - 0564
Xi'an, Shaanxi 710061, China
- Site 0564 · Contact
Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong 250012, China
- Jianbo Wang, Site 0528 · Contact · 18560081329
Recruiting
Shandong Cancer Hospital
Jinan, Shandong 250117, China
- Ligang Xing, Site 0297 · Contact · 86-15553181309
Recruiting
Local Institution - 0248
Shanghai, Shanghai Municipality 200433, China
- Site 0248 · Contact
Not yet recruiting

Showing the first 100 of 260 sites across 32 countries.

References and documents

Individual participant data

Plan to share: Yes — 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

Supporting information: Study protocol, Sap, Csr

Registry details

Key details

Study ID: NCT07361497
Lead sponsor: Bristol-Myers Squibb
Collaborators: BioNTech SE
Responsible party: Sponsor
First posted: Jan 23, 2026
Start date: Mar 16, 2026
Primary completion: Sep 18, 2030 (estimated)
Completion: Jan 13, 2034 (estimated)
Last update: Sep 30, 2026

Study contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Contact

Clinical.Trials@bms.com

855-907-3286

First line of the email MUST contain NCT # and Site #.

Contact

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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