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.
1 other identifier
interventional
850
31 countries
248
Brief Summary
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2026
Longer than P75 for phase_3
248 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2026
CompletedFirst Posted
Study publicly available on registry
January 23, 2026
CompletedStudy Start
First participant enrolled
March 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2033
June 3, 2026
June 1, 2026
4.5 years
January 21, 2026
June 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)
Up to 3 years
Secondary Outcomes (6)
Overall survival (OS)
Up to approximately 9 years
PFS by investigator (per RECIST v1.1)
Up to 3 years
Objective response (OR) by BICR (per RECIST v1.1)
Up to 3 years
Disease control rate (DCR) by BICR (per RECIST v1.1)
Up to 3 years
Duration of response (DOR) by BICR (per RECIST v1.1)
Up to 3 years
- +1 more secondary outcomes
Study Arms (2)
Arm A
EXPERIMENTALArm B
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- BioNTech SEcollaborator
Study Sites (255)
Southern Cancer Center Pc
Daphne, Alabama, 36526, United States
Local Institution - 0780
Chandler, Arizona, 85224, United States
Local Institution - 0585
Golden, Colorado, 80401, United States
Medical Oncology Hematology Consultants, PA
Newark, Delaware, 19713, United States
Local Institution - 0711
Ocala, Florida, 34474, United States
Local Institution - 0756
Marietta, Georgia, 30060, United States
Local Institution - 0398
Chicago, Illinois, 60637, United States
Local Institution - 0850
Evanston, Illinois, 60201, United States
Illinois Cancer Care
Peoria, Illinois, 61615, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804, United States
Local Institution - 0656
Lexington, Kentucky, 40536-0284, United States
Local Institution - 0603
Boston, Massachusetts, 02114-2621, United States
Local Institution - 0419
Detroit, Michigan, 48201, United States
Minnesota Oncology Hematology
Maple Grove, Minnesota, 55369, United States
Local Institution - 0142
Saint Paul, Minnesota, 55102, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Local Institution - 0339
Westbury, New York, 11590, United States
Local Institution - 0909
Westbury, New York, 11590, United States
Local Institution - 0493
Winston-Salem, North Carolina, 27103, United States
Local Institution - 0923
Akron, Ohio, 44302, United States
Local Institution - 0412
Cincinnati, Ohio, 45219, United States
Local Institution - 0359
Cleveland, Ohio, 44106-5066, United States
Local Institution - 0597
Cleveland, Ohio, 44195, United States
Local Institution - 0924
Mayfield Heights, Ohio, 44124, United States
Oncology Associates Of Oregon, Pc
Eugene, Oregon, 97401, United States
Northwest Cancer Specialists, P.C.
Happy Valley, Oregon, 97015, United States
Local Institution - 0480
Nashville, Tennessee, 37203, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Texas Oncology - Amarillo Cancer Center
Amarillo, Texas, 79124, United States
Texas Oncology-Austin Central
Austin, Texas, 78731, United States
Texas Oncology
Denton, Texas, 76210, United States
Local Institution - 0811
Fort Worth, Texas, 76104, United States
Local Institution - 0596
Houston, Texas, 77030, United States
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, 78229, United States
Texas Oncology - Northeast Texas
Tyler, Texas, 75702, United States
Blue Ridge Cancer Care
Christiansburg, Virginia, 24073, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Local Institution - 0093
Buenas Aires, Buenos Aires, C1049AAG, Argentina
Local Institution - 0082
Mar del Plata, Buenos Aires, B7600FZN, Argentina
Local Institution - 0097
Rosario, Santa Fe Province, 2000, Argentina
Local Institution - 0094
Buenos Aires, 1426, Argentina
Local Institution - 0078
Buenos Aires, 1430, Argentina
Local Institution - 0761
Buenos Aires, C1199ABB, Argentina
Local Institution - 0608
Córdoba, X5000, Argentina
Local Institution - 0313
Córdoba, X5016, Argentina
Gosford Hospital
Gosford, New South Wales, 2250, Australia
Local Institution - 0446
Penrith, New South Wales, 2750, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112, Australia
Grampians Health
Ballarat Central, Victoria, 3350, Australia
Local Institution - 0458
Epping, Victoria, 3076, Australia
Joondalup Health Campus
Joondalup, Western Australia, 6027, Australia
Local Institution - 0451
Wentworthville, NSW2145, Australia
Local Institution - 0190
Innsbruck, 6020, Austria
Local Institution - 0192
Linz, 4020, Austria
Local Institution - 0207
Vienna, A-1090, Austria
Local Institution - 0906
Brasschaat, Antwerpen, 2930, Belgium
Local Institution - 0122
Anderlecht, Bruxelles-Capitale, Région de, 1070, Belgium
Local Institution - 0111
Charleroi, Hainaut, 6060, Belgium
Local Institution - 0714
Genk, Limburg, 3600, Belgium
Local Institution - 0120
Ghent, Oost-Vlaanderen, 9000, Belgium
Local Institution - 0117
Sint-Niklaas, Oost-Vlaanderen, B-9100, Belgium
Local Institution - 0116
Leuven, Vlaams-Brabant, 3000, Belgium
Local Institution - 0615
Teresina, Piauí, 64049-200, Brazil
Local Institution - 0498
Natal/RN, Rio Grande do Norte, 59062-000, Brazil
Local Institution - 0619
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Local Institution - 0535
Barretos, São Paulo, 14784, Brazil
Local Institution - 0538
São José do Rio Preto, São Paulo, 15090-000, Brazil
Local Institution - 0912
São Paulo, 01246-000, Brazil
Local Institution - 0736
Haskovo, 6304, Bulgaria
Local Institution - 0551
Rousse, 7002, Bulgaria
Local Institution - 0826
Sofia, 1431, Bulgaria
Local Institution - 0732
Sofia, 1527, Bulgaria
Local Institution - 0838
Sofia, 1680, Bulgaria
Local Institution - 0337
Ottawa, Ontario, K1H 8L6, Canada
Local Institution - 0644
Montreal, Quebec, H3T 1M5, Canada
IUCPQ
Québec, G1V 4G5, Canada
Local Institution - 0910
Antofagasta, AN, 1240000, Chile
Local Institution - 0855
Las Condes, Arica y Parinacota Region, 7560908, Chile
Local Institution - 0478
Santiago, Santiago Metropolitan, 7500921, Chile
Local Institution - 0037
Santiago, Santiago Metropolitan, 7510032, Chile
Local Institution - 0077
Santiago, Santiago Metropolitan, 8420383, Chile
Local Institution - 0328
Viña del Mar, Valparaiso, 2520612, Chile
Local Institution - 0754
Beijing, Beijing Municipality, 100142, China
Local Institution - 0308
Chongqing, Chongqing Municipality, 400030, China
Local Institution - 0245
Fuzhou, Fujian, 350014, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515041, China
Local Institution - 0919
Shenzhen, Guangdong, 518036, China
Local Institution - 0249
Zhengzhou, Henan, 450008, China
Local Institution - 0911
Jingzhou, Hubei, 0, China
Local Institution - 0921
Wuhan, Hubei, 430014, China
Local Institution - 0813
Wuhan, Hubei, 430030, China
Local Institution - 0489
Changsha, Hunan, 410031, China
Local Institution - 0918
Suzhou, Jiangsu, 215006, China
Local Institution - 0254
Nanchang, Jiangxi, 330006, China
Local Institution - 0242
Shenyang, Liaoning, 110042, China
Local Institution - 0527
Xi'an, Shaanxi, 710004, China
Local Institution - 0528
Jinan, Shandong, 250012, China
Local Institution - 0297
Jinan, Shandong, 250117, China
Local Institution - 0248
Shanghai, Shanghai Municipality, 200433, China
Local Institution - 0542
Taiyuan, Shanxi, 030000, China
Local Institution - 0835
Chengdu, Sichuan, 610041, China
Local Institution - 0440
Chengdu, Sichuan, 610066, China
Local Institution - 0719
Hangzhou, Zhejiang, 310000, China
Local Institution - 0253
Linhai, Zhejiang, 317000, China
Local Institution - 0561
Guangzhou, 510060, China
Local Institution - 0301
Hangzhou, 215006, China
Local Institution - 0537
Shanghai Shi, 200030, China
Local Institution - 0564
Xi'an, 710061, China
Local Institution - 0029
Bordeaux, Aquitaine, 33076, France
Local Institution - 0130
Lyon Cedex08, Auvergne-Rhône-Alpes, 69373, France
Local Institution - 0129
Dijon, Côte-d'Or, 21079, France
Local Institution - 0716
Lille, Hauts-de-France, 59037, France
Local Institution - 0028
Montpellier, Hérault, 34298, France
Local Institution - 0127
Saint-Herblain, Loire-Atlantique, 44800, France
Local Institution - 0023
Toulouse, Midi-Pyrénées, 31400, France
Local Institution - 0689
Villejuif, Val-de-Marne, 94800, France
Local Institution - 0025
Limoges, 87042, France
Local Institution - 0024
Marseille, 13915, France
Local Institution - 0026
Paris, 75014, France
Local Institution - 0739
Augsburg, Bavaria, 86156, Germany
Local Institution - 0265
Koblenz, Rhineland-Palatinate, 56073, Germany
Local Institution - 0174
Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany
Local Institution - 0172
Kiel, Schleswig-Holstein, 24105, Germany
Local Institution - 0182
Jena, Thuringia, 7747, Germany
Local Institution - 0217
Berlin, 10117, Germany
Local Institution - 0215
Berlin, 14165, Germany
Local Institution - 0169
Göttingen, 37075, Germany
Local Institution - 0178
Gröbenzell, 82194, Germany
Local Institution - 0199
Haile, 06120, Germany
Local Institution - 0299
Hamburg, 22045, Germany
Local Institution - 0186
Immenhausen, 34376, Germany
Local Institution - 0187
Regensburg, 93053, Germany
Local Institution - 0416
Thessaloniki, Thessaloníki, 570 10, Greece
Local Institution - 0321
Larissa, Thessalía, 41110, Greece
Local Institution - 0391
Athens, 11 527, Greece
Local Institution - 0323
Athens, 115 26, Greece
Local Institution - 0324
Athens, 115 27, Greece
Local Institution - 0697
Thessaloniki, 56429, Greece
Local Institution - 0457
Tuenmen, NT, 0, Hong Kong
Local Institution - 0193
Hksar, 999077, Hong Kong
Local Institution - 0764
Shatin, 0, Hong Kong
Local Institution - 0139
Kecskemét, Bács-Kiskun county, 6000, Hungary
Local Institution - 0787
Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary
Local Institution - 0138
Budapest, 1121, Hungary
Local Institution - 0776
Farkasgyepű, 8582, Hungary
Local Institution - 0696
Törökbálint, 2045, Hungary
Local Institution - 0840
Eluru, Andhra Pradesh, 534002, India
Local Institution - 0927
Goraj, Gujarat, 391760, India
Local Institution - 0548
Pūlakkōd, Kerala, 673601, India
Local Institution - 0864
Aurangabad, Maharashtra, 431002, India
Local Institution - 0660
Mumbai, Maharashtra, 400012, India
Local Institution - 0663
Mumbai, Maharashtra, 400036, India
Local Institution - 0661
Nagpur, Maharashtra, 440001, India
Local Institution - 0664
Dwarka, National Capital Territory of Delhi, 110075, India
Local Institution - 0856
New Delhi, National Capital Territory of Delhi, 110085, India
Local Institution - 0657
Hyderabad, Telangana, 500033, India
Local Institution - 0547
Delhi, 110029, India
Local Institution - 0659
Pune, 411001, India
Local Institution - 0276
Cork, T12K199, Ireland
Local Institution - 0270
Dublin, D08 E9P6, Ireland
Local Institution - 0070
Dublin, D9, Ireland
Local Institution - 0304
Orbassano, Piedmont, 10043, Italy
Local Institution - 0669
Rome, Roma, 00128, Italy
Local Institution - 0269
Aviano (PN), 33081, Italy
Local Institution - 0668
Milan, 20132, Italy
Local Institution - 0667
Milan, 20141, Italy
Local Institution - 0275
Naples, 80131, Italy
Local Institution - 0390
Parma, 43126, Italy
Local Institution - 0670
Ravenna, 48121, Italy
Local Institution - 0014
Nagoya, Aichi-ken, 464-8681, Japan
Local Institution - 0701
Kobe, Hyōgo, 650-0017, Japan
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, 663-8501, Japan
Kanagawa cancer center
Yokohama, Kanagawa, 2418515, Japan
Local Institution - 0001
Sendai, Miyagi, 980-0873, Japan
Local Institution - 0907
Okayama, Okayama-ken, 700-8558, Japan
Kindai University Hospital
Sakai, Osaka, 590-0197, Japan
Local Institution - 0149
Hidaka, Saitama-Pref, 350-1298, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
Local Institution - 0018
Bunkyo Ku, Tokyo, 113-8677, Japan
Local Institution - 0016
Hirakata-shi, 573-1191, Japan
Local Institution - 0009
Minami-Ku, Fukuoka, 811-1347, Japan
Local Institution - 0157
Sagamihara, 252-0375, Japan
Local Institution - 0759
Sendai, 980-8574, Japan
Local Institution - 0772
Saltillo, Coahuila, 25279, Mexico
Local Institution - 0815
Tijuana, Estado de Baja California, 22010, Mexico
Local Institution - 0699
Zapopan, Jalisco, 45050, Mexico
Local Institution - 0330
Monterrey, Nuevo León, 64460, Mexico
Local Institution - 0914
Puebla City, 72530, Mexico
Local Institution - 0349
Querétaro, 76000, Mexico
Local Institution - 0243
Nijmegen, Gelderland, 6525 GA, Netherlands
Local Institution - 0095
Breda, North Brabant, 4818 CK, Netherlands
Local Institution - 0091
Amsterdam, North Holland, 1081 HV, Netherlands
Local Institution - 0087
Zwolle, Overijssel, 8025 AB, Netherlands
Local Institution - 0089
Groningen, 9713 GZ, Netherlands
Local Institution - 0092
Tilburg, 5000 LA, Netherlands
Local Institution - 0473
Lublin, Lublin Voivodeship, 20-954, Poland
Local Institution - 0556
Przemyśl, Podkarpackie Voivodeship, 37-700, Poland
Local Institution - 0681
Katowice, Silesian Voivodeship, 40-853, Poland
Local Institution - 0680
Opole, 45-372, Poland
Local Institution - 0219
Bucharest, Bucharest, 020335, Romania
Local Institution - 0046
Bucharest, 050098, Romania
Local Institution - 0168
Cluj-Napoca, 400015, Romania
Local Institution - 0045
Craiova, 200347, Romania
Local Institution - 0058
Floresti/ Cluj, 407280, Romania
Local Institution - 0184
Iași, 700106, Romania
Local Institution - 0164
Iași, 700483, Romania
Local Institution - 0650
Singapore, Central Singapore, 168583, Singapore
Local Institution - 0647
Singapore, 308442, Singapore
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea
Local Institution - 0041
L'Hospitalet Del Llobregat, Barcelona [Barcelona], 08908, Spain
Local Institution - 0086
Barakaldo, 48903, Spain
Local Institution - 0043
Barcelona, 08003, Spain
Local Institution - 0042
Barcelona, 08041, Spain
Local Institution - 0049
Madrid, 28041, Spain
Local Institution - 0570
Málaga, 29010, Spain
Local Institution - 0061
Seville, 41009, Spain
Local Institution - 0066
Valencia, 46010, Spain
Local Institution - 0044
Zaragoza, 50009, Spain
Local Institution - 0033
Gävle, Gävleborgs Län [se-21], 80187, Sweden
Local Institution - 0032
Solna, Stockholms Län [se-01], 171 64, Sweden
Local Institution - 0034
Uppsala, 751 85, Sweden
Universitaetsspital Basel
Basel, 4031, Switzerland
Ospedale Regionale Bellinzona e Valli
Bellinzona, CH-6500, Switzerland
Kantonsspital Münsterlingen - Spital Thurgau AG
Münsterlingen, 8596, Switzerland
Kantonsspital St Gallen
Sankt Gallen, 9007, Switzerland
National Taiwan University Hospital - Hsinchu branch
Zhubei, Hsinchu, 302, Taiwan
Local Institution - 0735
Chiayi City, 60090, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Local Institution - 0729
Taipei, 220, Taiwan
Local Institution - 0733
Bangkok, 10700, Thailand
Local Institution - 0917
Chiang Mai, 50200, Thailand
Local Institution - 0160
Khon Kaen, 40002, Thailand
Local Institution - 0728
Songkhla, 90110, Thailand
Local Institution - 0099
Adana, 01140, Turkey (Türkiye)
Local Institution - 0113
Adana, 01370, Turkey (Türkiye)
Local Institution - 0198
Antalya, 07100, Turkey (Türkiye)
Local Institution - 0109
Çankaya, 06680, Turkey (Türkiye)
Local Institution - 0096
Istanbul, 34214, Turkey (Türkiye)
Local Institution - 0107
Istanbul, 34732, Turkey (Türkiye)
The Christie NHS Foundation Trust
Manchester, Lancashire, M20 4BX, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 2QQ, United Kingdom
Velindre Cancer Centre
Cardiff, CF14 2TL, United Kingdom
Local Institution - 0257
Guildford, GU2 7XX, United Kingdom
Local Institution - 0693
Leeds, LS9 7TF, United Kingdom
Clatterbridge Cancer Centre - Liverpool
Liverpool, L9 7BA, United Kingdom
University College London Hospital
London, NW1 2BU, United Kingdom
Royal Marsden Hospital (Chelsea)
London, SW3 6JJ, United Kingdom
Local Institution - 0533
Middlesex, DA146LT, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Central Study Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2026
First Posted
January 23, 2026
Study Start
March 16, 2026
Primary Completion (Estimated)
September 18, 2030
Study Completion (Estimated)
December 31, 2033
Last Updated
June 3, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See Plan Description
- Access Criteria
- 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