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
257
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
257 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
January 13, 2034
September 30, 2026
September 1, 2026
4.5 years
January 21, 2026
September 29, 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 (260)
Southern Cancer Center Pc
Daphne, Alabama, 36526, United States
Intermountain Health Cancer Center Lutheran Hospital
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 - 0935
Plantation, Florida, 33322, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Endeavor Health
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
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536, United States
Local Institution - 0603
Boston, Massachusetts, 02114-2621, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Minnesota Oncology Hematology
Maple Grove, Minnesota, 55369, United States
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, 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
Optum Medical Care, PC
Westbury, New York, 11590, United States
Novant Health Pharmacy Oncology Specialists
Winston-Salem, North Carolina, 27103, United States
Akron General Medical Center
Akron, Ohio, 44302, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Cleveland Clinic - Hillcrest Hospital
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
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Tennessee Oncology
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
The Center For Cancer And Blood Disorders
Fort Worth, Texas, 76104, United States
The University of Texas-MD Anderson Cancer Center
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
Instituto Argentino De Diagnostico Y Tratamiento IADT
Buenas Aires, Buenos Aires, C1049AAG, Argentina
Investigaciones Oncologicas C Colon SA
Mar del Plata, Buenos Aires, 7600, Argentina
Hospital Privado Universitario de Córdoba
Córdoba, Córdoba Province, 5016, Argentina
Sanatorio Parque Rosario
Rosario, Santa Fe Province, 2000, Argentina
Instituto Medico Especializado Alexander Fleming
Buenos Aires, 1426, Argentina
Clinica Adventista Belgrano
Buenos Aires, 1430, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB, Argentina
Instituto de Investigaciones Clínicas Córdoba S.A.
Córdoba, X5000, Argentina
Gosford Hospital
Gosford, New South Wales, 2250, Australia
Nepean Hospital
Penrith, New South Wales, 2750, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112, Australia
Grampians Health
Ballarat Central, Victoria, 3350, Australia
Northern Hospital
Epping, Victoria, 3076, Australia
Joondalup Health Campus
Joondalup, Western Australia, 6027, Australia
Universitätsklinik Innsbruck
Innsbruck, 6020, Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020, Austria
Medizinische Universitaet Wien/AKH
Vienna, 1090, Austria
Local Institution - 0122
Anderlecht, Bruxelles-Capitale, Région de, 1070, Belgium
Grand Hôpital de Charleroi
Charleroi, Hainaut, 6060, Belgium
Ziekenhuis Oost-Limburg, Campus St.-Jan
Genk, Limburg, 3600, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
VITAZ
Sint-Niklaas, Oost-Vlaanderen, B-9100, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Algemeen Ziekenhuis klina
Brasschaat, 2930, Belgium
Vencer Centro de Pesquisa LTDA
Teresina, Piauí, 64049-200, Brazil
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59062-000, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14784400, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000, Brazil
Multiprofile Hospital for Active Treatment - Haskovo AD
Haskovo, 6304, Bulgaria
Complex Oncology Center - Ruse EOOD
Rousse, 7002, Bulgaria
"Sveta Ekaterina" Hospital
Sofia, 1431, Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
Sofia, 1527, Bulgaria
Diagnostic and Consultative Center Convex
Sofia, 1680, Bulgaria
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
St. Marys Hospital Center
Montreal, Quebec, H3T 1M5, Canada
IUCPQ
Québec, G1V 4G5, Canada
Bradford Hill Norte
Antofagasta, AN, 1240000, Chile
Centro de Oncología de Precisión
Las Condes, Arica y Parinacota Region, 7560908, Chile
FALP
Santiago, Santiago Metropolitan, 7500921, Chile
Bradfordhill
Santiago, Santiago Metropolitan, 8420383, Chile
Oncocentro APYS - Centro de Atencion Medica Oncologica Integral
Viña del Mar, Valparaiso, 2520612, Chile
Beijing Cancer hospital
Beijing, Beijing Municipality, 100142, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515041, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
Local Institution - 0249
Zhengzhou, Henan, 450008, China
Jingzhou First People's Hospital
Jingzhou, Hubei, 0, China
The Central Hospital of Wuhan
Wuhan, Hubei, 430014, China
Local Institution - 0813
Wuhan, Hubei, 430030, China
Local Institution - 0489
Changsha, Hunan, 410031, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Local Institution - 0242
Shenyang, Liaoning, 110042, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004, China
Local Institution - 0564
Xi'an, Shaanxi, 710061, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Local Institution - 0248
Shanghai, Shanghai Municipality, 200433, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000, China
Sichuan Cancer hospital
Chengdu, Sichuan, 610041, China
Local Institution - 0440
Chengdu, Sichuan, 610066, China
The second Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Taizhou Hospital Of Zhejiang Province
Linhai, Zhejiang, 317000, China
Sun Yat-sen University Cancer Center
Guangzhou, 510060, China
Local Institution - 0537
Shanghai Shi, 200030, China
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, Aquitaine, 33076, France
Centre Leon Berard
Lyon Cedex08, Auvergne-Rhône-Alpes, 69373, France
Local Institution - 0129
Dijon, Côte-d'Or, 21079, France
Institut Régional du Cancer Montpellier
Montpellier, Hérault, 34298, France
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
Saint-Herblain, Loire-Atlantique, 44800, France
CHU de Toulouse - Hopital Larrey
Toulouse, Midi-Pyrénées, 31400, France
CHU Lille - Institut Coeur Poumon
Lille, Nord, 59037, France
Local Institution - 0689
Villejuif, Val-de-Marne, 94800, France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
Limoges, 87042, France
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille, 13915, France
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, 75014, France
Klinikum Augsburg
Augsburg, Bavaria, 86156, Germany
Local Institution - 0929
Erlangen, Bavaria, 91054, Germany
Katholisches Klinikum-Koblenz Marienhof
Koblenz, Rhineland-Palatinate, 56073, Germany
Klinikum der Stadt Ludwigshafen gGmbH
Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany
Local Institution - 0934
Magdeburg, Saxony-Anhalt, 39120, Germany
Universitatsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105, Germany
Universitaetsklinikum Jena
Jena, Thuringia, 7747, Germany
Local Institution - 0217
Berlin, 10117, Germany
Local Institution - 0931
Berlin, 12351, Germany
Local Institution - 0215
Berlin, 14165, Germany
Local Institution - 0169
Göttingen, 37075, Germany
Asklepios Fachkliniken Muenchen-Gauting
Gröbenzell, 82194, Germany
Krankenhaus Martha-Maria Halle-Doelau Ggmbh
Haile, 06120, Germany
LungenClinic Grosshansdorf GmbH
Hamburg, 22045, Germany
Lungenfachklinik Immenhausen
Immenhausen, 34376, Germany
Universitaetsklinikum Regensburg
Regensburg, 93053, Germany
Thoracic General Hospital of Athens "I Sotiria"
Athens, Attikí, 115 27, Greece
General Hospital of Athens "Laiko"
Athens, Attikí, 11527, Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, Thessaloníki, 564 29, Greece
G. Papanikolaou General Hospital
Thessaloniki, Thessaloníki, 570 10, Greece
University General Hospital of Larissa
Larissa, Thessalía, 41110, Greece
Errikos Dunant Hospital Center
Athens, 115 26, Greece
Local Institution - 0457
Tuenmen, NT, 0, Hong Kong
Queen Mary Hospital
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
St. James's Hospital
Dublin, D08 E9P6, Ireland
Beaumont Hospital, Dublin
Dublin, D9, Ireland
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, Campania, 80131, Italy
Ospedale Santa Maria delle Croci
Ravenna, Emilia-Romagna, 48121, Italy
Cro-Irccs
Aviano, Friuli Venezia Giulia, 33081, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, Piedmont, 10043, Italy
Policlinico Universitario Campus Bio-Medico
Rome, Roma, 00128, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Istituto Europeo di Oncologia IRCCS
Milan, 20141, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, 43126, Italy
Local Institution - 0014
Nagoya, Aichi-ken, 464-8681, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, 663-8501, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0375, Japan
Kanagawa cancer center
Yokohama, Kanagawa, 2418515, Japan
Sendai Kousei Hospital
Sendai, Miyagi, 9810914, Japan
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191, Japan
Kindai University Hospital
Sakai, Osaka, 590-0197, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyo Ku, Tokyo, 113-8677, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Okayama University Hospital
Okayama, 700-8558, 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
Radboudumc
Nijmegen, Gelderland, 6525 GA, Netherlands
Amphia Ziekenhuis, locatie Breda Molengracht
Breda, North Brabant, 4818 CK, Netherlands
Local Institution - 0091
Amsterdam, North Holland, 1081 HV, Netherlands
Local Institution - 0087
Zwolle, Overijssel, 8025 AB, Netherlands
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
Local Institution - 0092
Tilburg, 5000 LA, Netherlands
Local Institution - 0473
Lublin, Lublin Voivodeship, 20-954, Poland
SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
Opole, Opole Voivodeship, 45-061, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemyśl, Podkarpackie Voivodeship, 37-700, Poland
Uniwersyteckie Centrum Kliniczne im. prof. K.Gibinskiego SUM w Katowicach
Katowice, Silesian Voivodeship, 40-853, Poland
Centrul de Diagnostic si Tratament Provita
Bucharest, Bucharest, 020335, Romania
SC Radiotherapy Center Cluj SRL
Florești, Cluj, 407280, Romania
Spitalul Universitar de Urgență București
Bucharest, 050098, Romania
Institutul Oncologic Cluj
Cluj-Napoca, 400015, Romania
Centrul de Oncologie Sf. Nectarie SRL
Craiova, 200542, Romania
S.C. Centrul de Oncologie Euroclinic S.R.L.
Iași, 700106, Romania
Institutul Regional de Oncologie
Iași, 700483, Romania
Oncomed
Timisoara, Timis, 300239, Romania
National Cancer Centre Singapore
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
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [Cataluña], 08041, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, 28041, Spain
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, 46010, Spain
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
Barakaldo, 48903, Spain
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitario Virgen De La Victoria
Málaga, 29010, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009, Spain
Sjukhuset I Gävle
Gävle, Gävleborgs Län [se-21], 80187, Sweden
Karolinska Universitetssjukhuset Solna
Solna, Stockholms Län [se-01], 171 64, Sweden
Akademiska sjukhuset
Uppsala, Uppsala Län [se-03], 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
Far Eastern Memorial Hospital
New Taipei City, 220, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Taiwan University Hospital
Taipei, 10002, 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
Local Institution - 0932
Newcastle upon Tyne, North East, NE77DN, United Kingdom
Local Institution - 0928
Birmingham, West Midlands, B9 5SS, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 2QQ, United Kingdom
Velindre Cancer Centre
Cardiff, CF14 2TL, United Kingdom
The Royal Surrey County Hospital NHS Foundation Trust
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
Mount Vernon Hospital
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)
January 13, 2034
Last Updated
September 30, 2026
Record last verified: 2026-09
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