Non-small Cell Lung Cancer (NSCLC)Phase 3NCT07361497
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 study testing Pumitamig and Durvalumab in people with Non-small Cell Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 259 sites in 32 countries.
Trial summary
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Pumitamig and Durvalumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 259 sitesin 32 countries
- Study dates
- 16 Mar 2026to 13 Jan 2034
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
259 sites in 32 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
259 sites in 32 countries
United States38 sites, 37 recruiting
- Recruiting
Akron General Medical Center
Akron, Ohio, 44302
James Stevenson, Site 0923, 216-636-6888
- Recruiting
Texas Oncology - Amarillo Cancer Center
Amarillo, Texas, 79124
Pankaj Khandelwal, Site 0908, 000-000-0000
- Recruiting
Texas Oncology-Austin Central
Austin, Texas, 78731
James Uyeki, Site 0857, 512-427-9400
- Not yet recruiting
Local Institution - 0603
Boston, Massachusetts, 02114-2621
Site 0603
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Everett Vokes, Site 0398, 773-503-0732
- Recruiting
Blue Ridge Cancer Care
Christiansburg, Virginia, 24073
Jerome Goldschmidt, Site 0133, 540-381-5291
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
Brittaney-Belle Gordon, Site 0412, 513-321-4333
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Matthew Mirsky, Site 0359, 301-980-8969
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
James Stevenson, Site 0597, 216-636-6888
- Recruiting
Missouri Cancer Associates
Columbia, Missouri, 65201
Caleb Smith, Site 0900
- Recruiting
Southern Cancer Center Pc
Daphne, Alabama, 36526
Michael Meshad, Site 0898, 111-111-1111
- Recruiting
Texas Oncology
Denton, Texas, 76210
Kartik Konduri, Site 0894, 214-370-1000
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Khalil Choucair, Site 0419
- Recruiting
Oncology Associates Of Oregon, Pc
Eugene, Oregon, 97401
Bo Wang, Site 0895, 541-683-5001
- Recruiting
Endeavor Health
Evanston, Illinois, 60201
Dhruv Bansal, Site 0850, 847-570-2112
- Recruiting
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
Ahad Sadiq, Site 0317, 260-436-0800
- Recruiting
The Center For Cancer And Blood Disorders
Fort Worth, Texas, 76104
Ray Page, Site 0811, 817-759-7000
- Recruiting
Intermountain Health Cancer Center Lutheran Hospital
Golden, Colorado, 80401
Karng Log, Site 0585, 303-403-7333
- Recruiting
Northwest Cancer Specialists, P.C.
Happy Valley, Oregon, 97015
Anthony Van Ho, Site 0302, 503-885-5411
- Recruiting
The University of Texas-MD Anderson Cancer Center
Houston, Texas, 77030
Tina Cascone, Site 0596, 713-792-6363
- Recruiting
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
Zhonglin Hao, Site 0656, 859-218-6704
- Recruiting
Minnesota Oncology Hematology
Maple Grove, Minnesota, 55369
Daniel Mundt, Site 0322
- Recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060
Walid Shaib, Site 0756, 770-281-5124
- Recruiting
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, 44124
James Stevenson, Site 0924, 216-636-6888
- Recruiting
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Charlene Fares, Site 0142, 651-241-7025
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Melissa Johnson, Site 0240, 615-329-7274
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
Wade Iams, Site 0480, 615-322-4967
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Mark Awad, Site 0606
- Recruiting
Medical Oncology Hematology Consultants, PA
Newark, Delaware, 19713
Jamal Misleh, Site 0896, 302-366-1200
- Recruiting
Virginia Oncology Associates
Norfolk, Virginia, 23502
John Paschold, Site 0250
- Not yet recruiting
Local Institution - 0711
Ocala, Florida, 34474
Site 0711
- Recruiting
Illinois Cancer Care
Peoria, Illinois, 61615
Srinivas Jujjavarapu, Site 0897, 309-243-3000
- Recruiting
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, 78229
Krishna Alluri, Site 0902, 210-656-7177
- Recruiting
Florida Clinical Trials Group
Tamarac, Florida, 33321
Chintan Gandhi, Site 0935, 561-447-0614
- Recruiting
Texas Oncology - Northeast Texas
Tyler, Texas, 75702
Sarah Wang, Site 0899, 903-579-9800
- Withdrawn
Local Institution - 0339
Westbury, New York, 11590
- Recruiting
Optum Medical Care, PC
Westbury, New York, 11590
Jonathan Goldberg, Site 0909, 914-242-2991
- Recruiting
Novant Health Pharmacy Oncology Specialists
Winston-Salem, North Carolina, 27103
Garrett Sherwood, Site 0493, 336-209-0239
China26 sites, 25 recruiting
- Recruiting
Beijing Cancer hospital
Beijing, Beijing Municipality, 100142
Anhui Shi, Site 0754, 8613901136511
- Not yet recruiting
Local Institution - 0489
Changsha, Hunan, 410031
Site 0489
- Recruiting
Sichuan Cancer hospital
Chengdu, Sichuan, 610041
Qifeng Wang, Site 0835, 8618227667667
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610066
Jianxin Xue, Site 0440, 8618982251798
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Wei Zhou, Site 0308, 13883465672
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Haishan Wu, Site 0245, 8613696834132
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, 510060
Ming Chen, Site 0561, 13600470913
- Recruiting
The second Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
WEN LI, Site 0719, 13958194313
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Yongling Ji, Site 0301, 13958085251
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Jianbo Wang, Site 0528, 18560081329
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Ligang Xing, Site 0297, 86-15553181309
- Recruiting
Jingzhou First People's Hospital
Jingzhou, Hubei, 0
Yonghua Yang, Site 0911, 8618163137331
- Recruiting
Taizhou Hospital Of Zhejiang Province
Linhai, Zhejiang, 317000
Dongqing LV, Site 0253, 13867622009
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Anwen Liu, Site 0254, 8613767120022
- Not yet recruiting
Local Institution - 0248
Shanghai, Shanghai Municipality, 200433
Site 0248
- Not yet recruiting
Local Institution - 0537
Shanghai Shi, 200030
Site 0537
- Recruiting
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
Wen Lin, Site 0298, 13612388011
- Not yet recruiting
Local Institution - 0242
Shenyang, Liaoning, 110042
Site 0242
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Yajie Liu, Site 0919, 13823394075
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Songbing Qin, Site 0918, 13771975906
- Recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000
Hongwei Li, Site 0542, 8613015301402
- Recruiting
The Central Hospital of Wuhan
Wuhan, Hubei, 430014
Hongda Lu, Site 0921
- Withdrawn
Local Institution - 0813
Wuhan, Hubei, 430030
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004
Hui Guo, Site 0527, 8613572824106
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
suxia han, Site 0564, 13991822099
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Qiming Wang, Site 0249, 8613783590691
Germany16 sites, 14 recruiting
- Recruiting
Klinikum Augsburg
Augsburg, Bavaria, 86156
Bjoern Hackanson, Site 0739, +49821400161767
- Withdrawn
Local Institution - 0217
Berlin, 10117
- Not yet recruiting
Local Institution - 0931
Berlin, 12351
Site 0931
- Not yet recruiting
Local Institution - 0215
Berlin, 14165
Site 0215
- Not yet recruiting
Local Institution - 0929
Erlangen, Bavaria, 91054
Site 0929
- Withdrawn
Local Institution - 0169
Göttingen, 37075
- Recruiting
Asklepios Fachkliniken Muenchen-Gauting
Gröbenzell, 82194
Niels Reinmuth, Site 0178, 004989857914001
- Recruiting
Christliches Klinikum Halle (Saale) GmbH
Halle, 06120
Miriam Moeller, Site 0199, 00493455591440
- Recruiting
LungenClinic Grosshansdorf GmbH
Hamburg, 22045
Martin Reck, Site 0299, 041026012101
- Recruiting
Lungenfachklinik Immenhausen
Immenhausen, 34376
Achim Rittmeyer, Site 0186, 4956735011573
- Recruiting
Universitaetsklinikum Jena
Jena, Thuringia, 7747
Jakob Hammersen, Site 0182, 4936419396622
- Recruiting
Universitatsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105
Sabine Bohnet, Site 0172, 4945150045002
- Recruiting
Katholisches Klinikum-Koblenz Marienhof
Koblenz, Rhineland-Palatinate, 56073
Annette Mueller, Site 0265, +49 261 496-3510
- Recruiting
Klinikum der Stadt Ludwigshafen gGmbH
Ludwigshafen am Rhein, Rhineland-Palatinate, 67063
David Klank, Site 0174
- Not yet recruiting
Local Institution - 0934
Magdeburg, Saxony-Anhalt, 39120
Site 0934
- Recruiting
Universitaetsklinikum Regensburg
Regensburg, 93053
Christian Schulz, Site 0187, 0049-(0)941-944-1728
Japan14 sites, 14 recruiting
- Recruiting
Tokyo Metropolitan Komagome Hospital
Bunkyo Ku, Tokyo, 113-8677
kanako shinada, Site 0018, 81-3-3823-2101
- Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Masafumi Yamaguchi, Site 0009, 81925413231
- Recruiting
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
Naoki Inui, Site 0158, 81534352356
- Recruiting
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298
Hiroshi Kagamu, Site 0149, 042-984-4111
- Recruiting
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191
Takayasu Kurata, Site 0016, 81728042503
- Recruiting
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Motoko Tachihara, Site 0701, +81783825660
- Recruiting
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
Junichi Shimizu, Site 0014, 81527626111
- Recruiting
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, 663-8501
Takashi Kijima, Site 0154, 81798456111
- Recruiting
Okayama University Hospital
Okayama, 700-8558
Eiki Ichihara, Site 0907, 81862357534
- Recruiting
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0375
Katsuhiko Naoki, Site 0157, 042-778-8111
- Recruiting
Kindai University Hospital
Sakai, Osaka, 590-0197
Hidetoshi Hayashi, Site 0002, 81723681184
- Recruiting
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Eisaku Miyauchi, Site 0759, 09044797035
- Recruiting
Sendai Kousei Hospital
Sendai, Miyagi, 9810914
Shunichi Sugawara, Site 0001, 81227288000
- Recruiting
Kanagawa cancer center
Yokohama, Kanagawa, 2418515
Shuji Murakami, Site 0008, 81455202222
United Kingdom12 sites, 11 recruiting
- Not yet recruiting
Local Institution - 0928
Birmingham, West Midlands, B9 5SS
Site 0928
- Recruiting
Addenbrooke's Hospital
Cambridge, CB2 2QQ
Huiqi Yang, Site 0672, +44(0)1223 805000
- Recruiting
Velindre Cancer Centre
Cardiff, CF14 2TL
paul shaw, Site 0289, +44 29 2061 5888
- Recruiting
The Royal Surrey County Hospital NHS Foundation Trust
Guildford, GU2 7XX
Ajay Mehta, Site 0257, +44 1483 571122
- Withdrawn
Local Institution - 0693
Leeds, LS9 7TF
- Recruiting
Clatterbridge Cancer Centre - Liverpool
Liverpool, L9 7BA
Carles Escriu, Site 0232, +44 151 556 5000
- Recruiting
University College London Hospital
London, NW1 2BU
Crispin Hiley, Site 0296, +44 20 3456 7890
- Recruiting
Royal Marsden Hospital (Chelsea)
London, SW3 6JJ
Michael Davidson, Site 0235, +44 20 7352 8171
- Recruiting
The Christie NHS Foundation Trust
Manchester, Lancashire, M20 4BX
Martin Igor Gomez Randulfe Rodriguez, Site 0239, +44(0)161 446 3000
- Recruiting
Mount Vernon Hospital
Middlesex, DA146LT
Suraiya Dubash, Site 0533, +44 1923 826111
- Not yet recruiting
Local Institution - 0932
Newcastle upon Tyne, North East, NE77DN
Site 0932
- Recruiting
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
Michael Davidson, Site 0913, +44(0)20 8642 6011
France11 sites, 11 recruiting
- Recruiting
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, Aquitaine, 33076
Sophie Cousin, Site 0029, 33556333229
- Not yet recruiting
Local Institution - 0129
Dijon, Côte-d'Or, 21079
Site 0129
- Recruiting
CHU Lille - Institut Coeur Poumon
Lille, Nord, 59037
Arnaud Scherpereel, Site 0716, 33320444998
- Recruiting
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
Limoges, 87042
Thomas Egenod, Site 0025, 33555056892
- Recruiting
Centre Leon Berard
Lyon Cedex08, Auvergne-Rhône-Alpes, 69373
Maurice Perol, Site 0130, 33426556761
- Recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille, 13915
Laurent Greillier, Site 0024, 33491324400
- Recruiting
Institut Régional du Cancer Montpellier
Montpellier, Hérault, 34298
Boisselier Pierre, Site 0028, +33467613792
- Recruiting
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, 75014
Marie Wislez, Site 0026, 33158413091
- Recruiting
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
Saint-Herblain, Loire-Atlantique, 44800
Elvire Pons-Tostivint, Site 0127, +33676133810
- Recruiting
CHU de Toulouse - Hopital Larrey
Toulouse, Midi-Pyrénées, 31400
Julien Mazieres, Site 0023, 33567771837
- Not yet recruiting
Local Institution - 0689
Villejuif, Val-de-Marne, 94800
Site 0689
India11 sites, 11 recruiting
- Not yet recruiting
Local Institution - 0864
Chhatrapati Sambhajinagar, Maharashtra, 431002
Site 0864
- Not yet recruiting
Local Institution - 0547
Delhi, 110029
Site 0547
- Not yet recruiting
Local Institution - 0664
Dwarka, National Capital Territory of Delhi, 110075
Site 0664
- Not yet recruiting
Local Institution - 0840
Eluru, Andhra Pradesh, 534002
Site 0840
- Not yet recruiting
Local Institution - 0927
Goraj, Gujarat, 391760
Site 0927
- Not yet recruiting
Local Institution - 0657
Hyderabad, Telangana, 500033
Site 0657
- Not yet recruiting
Local Institution - 0660
Mumbai, Maharashtra, 400012
Site 0660
- Not yet recruiting
Local Institution - 0661
Nagpur, Maharashtra, 440001
Site 0661
- Not yet recruiting
Local Institution - 0856
New Delhi, National Capital Territory of Delhi, 110085
Site 0856
- Not yet recruiting
Local Institution - 0548
Pūlakkōd, Kerala, 673601
Site 0548
- Not yet recruiting
Local Institution - 0659
Pune, 411001
Site 0659
Spain9 sites, 9 recruiting
- Recruiting
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
Barakaldo, 48903
Raquel Casas Cornejo, Site 0086, +34946006333
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [Cataluña], 08041
Margarita Majem Tarruella, Site 0042, 34935565651
- Recruiting
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003
Edurne Arriola Aperribay, Site 0043, +34932483137
- Not yet recruiting
Local Institution - 0041
L'Hospitalet Del Llobregat, Barcelona [Barcelona], 08908
Site 0041
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, 28041
Luis Paz-Ares Rodriguez, Site 0049, 0034913908922
- Recruiting
Hospital Universitario Virgen De La Victoria
Málaga, 29010
Jose Carlos Benitez Montañez, Site 0570, 34951308130
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
David Vicente Baz, Site 0061, 34955008932
- Recruiting
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, 46010
Amelia Insa Molla, Site 0066, 34961973500x436633
- Recruiting
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009
Estefania Arevalo Vazquez, Site 0044, +0034677872686
Argentina8 sites, 8 recruiting
- Recruiting
Instituto Argentino De Diagnostico Y Tratamiento IADT
Buenas Aires, Buenos Aires, C1049AAG
Juan Cundom, Site 0093, (+54911)4162-5353
- Recruiting
Instituto Medico Especializado Alexander Fleming
Buenos Aires, 1426
Claudio Martin, Site 0094, +541132218900
- Recruiting
Clinica Adventista Belgrano
Buenos Aires, 1430
Aldo Perfetti, Site 0078, 5491132682903
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB
Yamila Ferreira, Site 0761, 11-49590200ext8159
- Recruiting
Hospital Privado Universitario de Córdoba
Córdoba, Córdoba Province, 5016
Jeremias Sierra, Site 0313, 543514862400
- Recruiting
Instituto de Investigaciones Clínicas Córdoba S.A.
Córdoba, X5000
Nicolas Castagneris, Site 0608, 549351368119
- Recruiting
Investigaciones Oncologicas C Colon SA
Mar del Plata, Buenos Aires, 7600
Ignacio Casarini, Site 0082, +5492235937663
- Recruiting
Sanatorio Parque Rosario
Rosario, Santa Fe Province, 2000
Gaston Martinengo, Site 0097, 5493416955611
Italy8 sites, 8 recruiting
- Recruiting
Cro-Irccs
Aviano, Friuli Venezia Giulia, 33081
Alessandra Bearz, Site 0269, 390434659294
- Recruiting
Ospedale San Raffaele
Milan, 20132
Roberto Ferrara, Site 0668, 390223903829
- Recruiting
Istituto Europeo di Oncologia IRCCS
Milan, 20141
Ilaria Attili, Site 0667, 00390257489482
- Recruiting
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, Campania, 80131
Alessandro Morabito, Site 0275, 390817770291
- Recruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, Piedmont, 10043
Silvia Novello, Site 0304, 390119026322
- Recruiting
Azienda Ospedaliero Universitaria di Parma
Parma, 43126
Marcello Tiseo, Site 0390, 390521702682
- Recruiting
Ospedale Santa Maria delle Croci
Ravenna, Emilia-Romagna, 48121
Manolo D Arcangelo, Site 0670, 390544285330
- Recruiting
Policlinico Universitario Campus Bio-Medico
Rome, Roma, 00128
Sara Ramella, Site 0669, 0039 3470112401
Romania8 sites, 8 recruiting
- Recruiting
Centrul de Diagnostic si Tratament Provita
Bucharest, Bucharest, 020335
Mircea Dediu, Site 0219, 0040744432443
- Recruiting
Spitalul Universitar de Urgență București
Bucharest, 050098
Georgeta Iorga, Site 0046, 0040721245891
- Recruiting
Institutul Oncologic Cluj
Cluj-Napoca, 400015
Tudor Ciuleanu, Site 0168, 40745646368
- Recruiting
Centrul de Oncologie Sf. Nectarie SRL
Craiova, 200542
Michael Schenker, Site 0045, 40727774974
- Recruiting
SC Radiotherapy Center Cluj SRL
Florești, Cluj, 407280
Andrei Ungureanu, Site 0058, 40742206212
- Recruiting
S.C. Centrul de Oncologie Euroclinic S.R.L.
Iași, 700106
Constantin Volovat, Site 0184, 40746110096
- Recruiting
Institutul Regional de Oncologie
Iași, 700483
Dana Clement, Site 0164, 40744692062
- Recruiting
Oncomed
Timisoara, Timis, 300239
Daniela Sirbu, Site 0037, 40744571617
Australia7 sites, 7 recruiting
- Recruiting
Grampians Health
Ballarat Central, Victoria, 3350
Wasek Faisal, Site 0442, 61(03)53208500
- Recruiting
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112
Joanne Tang, Site 0448, 08 7117 7265
- Recruiting
Northern Hospital
Epping, Victoria, 3076
Vishal Boolell, Site 0458, (03) 9485 9068
- Recruiting
Gosford Hospital
Gosford, New South Wales, 2250
Matthew Chan, Site 0456, +61243209890
- Recruiting
Joondalup Health Campus
Joondalup, Western Australia, 6027
Arman Hasani, Site 0476, +61 8 9400 9897
- Recruiting
Nepean Hospital
Penrith, New South Wales, 2750
Deme Karikios, Site 0446, (02) 4734 1751
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Adnan Nagrial, Site 0451, 0288905200
Belgium7 sites, 7 recruiting
- Not yet recruiting
Local Institution - 0122
Anderlecht, Bruxelles-Capitale, Région de, 1070
Site 0122
- Recruiting
Algemeen Ziekenhuis klina
Brasschaat, 2930
Vincent Geldhof, Site 0906, +3234368061
- Recruiting
Grand Hôpital de Charleroi
Charleroi, Hainaut, 6060
Benoit Colinet, Site 0111, +32.60.11.90.73
- Recruiting
Ziekenhuis Oost-Limburg, Campus St.-Jan
Genk, Limburg, 3600
Maarten Criel, Site 0714, +3289808260
- Recruiting
UZ Gent
Ghent, Oost-Vlaanderen, 9000
Veerle Surmont, Site 0120, 32933229500
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
christophe Dooms, Site 0116, 003216340961
- Recruiting
VITAZ
Sint-Niklaas, Oost-Vlaanderen, B-9100
Koenraad Deschepper, Site 0117, 3237602327
Brazil6 sites, 6 recruiting
- Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14784400
Josiane Dias, Site 0535, 17996782301
- Recruiting
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59062-000
Joilda Rego, Site 0498, 558440095595
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Tiago Heinen, Site 0619, 555133598619
- Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
JOÃO SOLER, Site 0538, 551732015054
- Recruiting
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000
Fernanda Fujiki, Site 0912, +551138932615
- Recruiting
Vencer Centro de Pesquisa LTDA
Teresina, Piauí, 64049-200
CLAUDIO ROCHA, Site 0615, 5586999007799
Greece6 sites, 6 recruiting
- Recruiting
Thoracic General Hospital of Athens "I Sotiria"
Athens, Attikí, 115 27
Konstantinos Syrigos, Site 0324, +302107700220
- Recruiting
General Hospital of Athens "Laiko"
Athens, Attikí, 11527
Dimitrios Ziogas, Site 0391, 306936490499
- Recruiting
Errikos Dunant Hospital Center
Athens, 115 26
IOANNIS MOUNTZIOS, Site 0323, +306983519989
- Recruiting
University General Hospital of Larissa
Larissa, Thessalía, 41110
Athanasios Kotsakis, Site 0321, 302413502124
- Recruiting
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, Thessaloníki, 564 29
Georgios Lazaridis, Site 0697, 302313323959
- Recruiting
G. Papanikolaou General Hospital
Thessaloniki, Thessaloníki, 570 10
Dionisios Spyratos, Site 0416, 6979490052
Mexico6 sites, 6 recruiting
- Not yet recruiting
Local Institution - 0330
Monterrey, Nuevo León, 64460
Site 0330
- Not yet recruiting
Local Institution - 0914
Puebla City, 72530
Site 0914
- Not yet recruiting
Local Institution - 0349
Querétaro, 76000
Site 0349
- Not yet recruiting
Local Institution - 0772
Saltillo, Coahuila, 25279
Site 0772
- Not yet recruiting
Local Institution - 0815
Tijuana, Estado de Baja California, 22010
Site 0815
- Not yet recruiting
Local Institution - 0699
Zapopan, Jalisco, 45050
Site 0699
Netherlands6 sites, 6 recruiting
- Recruiting
Amsterdam UMC, locatie VUmc
Amsterdam, North Holland, 1081 HV
Sayed Hashemi, Site 0091, 0641292051
- Recruiting
Amphia Ziekenhuis, locatie Breda Molengracht
Breda, North Brabant, 4818 CK
Lysanne Lievense, Site 0095, 0031765952531
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
T.Jeroen Hiltermann, Site 0089, (3150)361-3532
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525 GA
Wouter van Geffen, Site 0243, (024)3638114
- Not yet recruiting
Local Institution - 0092
Tilburg, 5000 LA
Site 0092
- Not yet recruiting
Local Institution - 0087
Zwolle, Overijssel, 8025 AB
Site 0087
South Korea6 sites, 6 recruiting
- Recruiting
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644
Ki Hyeong Lee, Site 0052, 82432696015
- Recruiting
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620
Yu Jung Kim, Site 0151, +82-31-787-7041
- Recruiting
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03080
Miso Kim, Site 0055, 82220724035
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], 03722
Hye Ryun Kim, Site 0063, 82222284190
- Recruiting
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Dae Ho Lee, Site 0064, 82230103214
- Recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351
Jin Seok Ahn, Site 0035, 821099333453
Turkey (Türkiye)6 sites, 6 recruiting
- Not yet recruiting
Local Institution - 0099
Adana, 01140
Site 0099
- Not yet recruiting
Local Institution - 0113
Adana, 01370
Site 0113
- Not yet recruiting
Local Institution - 0198
Antalya, 07100
Site 0198
- Not yet recruiting
Local Institution - 0109
Çankaya, 06680
Site 0109
- Not yet recruiting
Local Institution - 0096
Istanbul, 34214
Site 0096
- Not yet recruiting
Local Institution - 0107
Istanbul, 34732
Site 0107
Bulgaria5 sites, 5 recruiting
- Recruiting
Multiprofile Hospital for Active Treatment - Haskovo AD
Haskovo, 6304
Stoil Boychev, Site 0736, +359889214157
- Recruiting
Complex Oncology Center - Ruse EOOD
Rousse, 7002
Nikolay Nikolaev, Site 0551, 0887098616
- Recruiting
"Sveta Ekaterina" Hospital
Sofia, 1431
Galina Kurteva, Site 0826, +359887623916
- Recruiting
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
Sofia, 1527
Kremena Vasileva, Site 0732
- Recruiting
Diagnostic and Consultative Center Convex
Sofia, 1680
Petya Balikova, Site 0838, +359 893582321
Chile5 sites, 5 recruiting
- Recruiting
Bradford Hill Norte
Antofagasta, AN, 1240000
Angela Estay, Site 0910, 56994198125
- Recruiting
Centro de Oncología de Precisión
Las Condes, Arica y Parinacota Region, 7560908
Pamela Salman Boghikian, Site 0855
- Recruiting
FALP
Santiago, Santiago Metropolitan, 7500921
Christian Caglevic, Site 0478, 56224457254
- Recruiting
Bradfordhill
Santiago, Santiago Metropolitan, 8420383
Carlos Rojas, Site 0077, +56998744662
- Recruiting
Oncocentro APYS - Centro de Atencion Medica Oncologica Integral
Viña del Mar, Valparaiso, 2520612
Alejandro Acevedo Gaete, Site 0328, +56992369820
Hungary5 sites, 5 recruiting
- Not yet recruiting
Local Institution - 0138
Budapest, 1121
Site 0138
- Recruiting
Farkasgyepui Tudogyogyintezet
Farkasgyepű, Veszprém megye, 8582
Zsolt Kiraly, Site 0776, 36209264476
- Not yet recruiting
Local Institution - 0139
Kecskemét, Bács-Kiskun county, 6000
Site 0139
- Not yet recruiting
Local Institution - 0787
Szolnok, Jász-Nagykun-Szolnok, 5000
Site 0787
- Not yet recruiting
Local Institution - 0696
Törökbálint, 2045
Site 0696
Poland4 sites, 4 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne im. prof. K.Gibinskiego SUM w Katowicach
Katowice, Silesian Voivodeship, 40-853
Jacek Kabut, Site 0681, +48604534549
- Not yet recruiting
Local Institution - 0473
Lublin, Lublin Voivodeship, 20-954
Site 0473
- Recruiting
SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
Opole, Opole Voivodeship, 45-061
Barbara Radecka, Site 0680, 48502313767
- Recruiting
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemyśl, Podkarpackie Voivodeship, 37-700
Kamil Kuc, Site 0556, 661957237
Switzerland4 sites, 4 recruiting
- Recruiting
Universitaetsspital Basel
Basel, 4031
Benjamin Thiele, Site 0222
- Recruiting
Ospedale Regionale Bellinzona e Valli
Bellinzona, CH-6500
Martina Imbimbo, Site 0166, 41(0)918119631
- Recruiting
Kantonsspital Münsterlingen - Spital Thurgau AG
Münsterlingen, 8596
Ioannis Metaxas, Site 0738, +41581447850
- Recruiting
Kantonsspital St Gallen
Sankt Gallen, 9007
Markus Joerger, Site 0165, 41714941111
Taiwan4 sites, 4 recruiting
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, 220
Cheng-Yu Chang, Site 0729, 886289667000ext.1815
- Recruiting
Taichung Veterans General Hospital
Taichung, 407
Tsung-Ying Yang, Site 0735, 8864235925253218
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Jin-Yuan Shih, Site 0726, 88622312345662905
- Recruiting
National Taiwan University Hospital - Hsinchu branch
Zhubei, Hsinchu, 302
Jih-Hsiang Lee, Site 0734, 886223368239
Thailand4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0733
Bangkok, 10700
Site 0733
- Not yet recruiting
Local Institution - 0917
Chiang Mai, 50200
Site 0917
- Not yet recruiting
Local Institution - 0160
Khon Kaen, 40002
Site 0160
- Not yet recruiting
Local Institution - 0728
Songkhla, 90110
Site 0728
Austria3 sites, 3 recruiting
- Recruiting
Universitätsklinik Innsbruck
Innsbruck, 6020
Andreas Pircher, Site 0190, 4351250483584
- Recruiting
Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020
Dominik Maurer, Site 0192, 4373276764414
- Recruiting
Medizinische Universitaet Wien/AKH
Vienna, 1090
Thorsten Fuereder, Site 0207, 4314040044450
Canada3 sites, 3 recruiting
- Recruiting
St. Marys Hospital Center
Montreal, Quebec, H3T 1M5
Adrian Langleben, Site 0644, 514-345-3511-3793
- Recruiting
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
Paul Wheatley-Price, Site 0337, 613737770070175
- Recruiting
IUCPQ
Québec, G1V 4G5
Maude Dubé-Pelletier, Site 0682, 418-656-8711
Hong Kong3 sites, 3 recruiting
- Recruiting
Queen Mary Hospital
Hksar, 999077
Rina Hui, Site 0193, +85239103299
- Not yet recruiting
Local Institution - 0764
Shatin, 0
Site 0764
- Not yet recruiting
Local Institution - 0457
Tuenmen, NT, 0
Site 0457
Ireland3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0276
Cork, T12K199
Site 0276
- Recruiting
St. James's Hospital
Dublin, D08 E9P6
Patrick Forde, Site 0270, +353 1 410 3000
- Recruiting
Beaumont Hospital, Dublin
Dublin, D9
Jarushka Naidoo, Site 0070, +353 1 809 3000
Sweden3 sites, 3 recruiting
- Recruiting
Sjukhuset I Gävle
Gävle, Gävleborgs Län [se-21], 80187
Johan Isaksson, Site 0033, +46 26 18 00 00
- Recruiting
Karolinska Universitetssjukhuset Solna
Solna, Stockholms Län [se-01], 171 64
Asaf Dan, Site 0032, +46 8 123 700 00
- Recruiting
Akademiska sjukhuset
Uppsala, Uppsala Län [se-03], 751 85
Georg Holgersson, Site 0034, +46 18 611 00 00
Singapore2 sites, 2 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
Amanda Seet Oon Lim, Site 0650
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
Puey Ling CHIA, Site 0647, 68894747
About this study
Official title: 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.
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- Pumitamig, Durvalumab
- Keywords
- Pumitamig, Locally advanced, Unresectable, Stage 3 Non-small Cell Lung Cancer (NSCLC), CA2660001
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PumitamigDrug
Also called BMS-986545
Specified dose on specified days
DurvalumabDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: Pumitamig |
| Arm B | Active comparator | Not described Receives: Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)
Measured: Up to 3 years
Secondary outcomes (6)
Overall survival (OS)
Measured: Up to approximately 9 years
PFS by investigator (per RECIST v1.1)
Measured: Up to 3 years
Objective response (OR) by BICR (per RECIST v1.1)
Measured: Up to 3 years
Disease control rate (DCR) by BICR (per RECIST v1.1)
Measured: Up to 3 years
Duration of response (DOR) by BICR (per RECIST v1.1)
Measured: Up to 3 years
Time to Response (TTR) by BICR (per RECIST v1.1)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start16 Mar 2026
- Primary completion18 Sep 2030 (estimated)
- Study completion13 Jan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361497
- Sponsor's protocol ID
- CA266-0001
- Status last verified
- Nov 2026
- First submitted
- 21 Jan 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07361497
- Acronym / sponsor ID
- CA266-0001
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Keywords
- Pumitamig, Locally advanced, Unresectable, Stage 3 Non-small Cell Lung Cancer (NSCLC), CA2660001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 18 Sep 2030 (estimated)
- Study completion
- 13 Jan 2034 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Pumitamig |
| Arm B | Active comparator | Drug: Durvalumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PumitamigAlso: BMS-986545Specified dose on specified days | Drug | Arm A |
| DurvalumabSpecified dose on specified days | Drug | Arm B |
Primary outcome
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
6 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
259 sites in 32 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pumitamig and Durvalumab in people with Non-small Cell Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 259 sites in 32 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 259 sites in United States, China, Germany, Japan, United Kingdom and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.