A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)

June 2, 2026 updated by: Bristol-Myers Squibb

ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥ 50%.

The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.

Study Overview

Status

Recruiting

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

750

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Contact Backup

Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Phone Number: 855-907-3286
Email: Clinical.Trials@bms.com

Study Locations

Argentina
- - Buenos Aires, Argentina, 1430
    - Not yet recruiting
    - Local Institution - 0058
    - Contact:
      
      Site 0058
  - Córdoba, Argentina, X5000BAL
    - Not yet recruiting
    - Local Institution - 0374
    - Contact:
      
      Site 0374
- Buenos Aires
  - Mar del Plata, Buenos Aires, Argentina, B7600FZN
    - Not yet recruiting
    - Local Institution - 0076
    - Contact:
      
      Site 0076
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, 2000
    - Not yet recruiting
    - Local Institution - 0229
    - Contact:
      
      Site 0229
  - Rosario, Santa Fe Province, Argentina, 2000
    - Not yet recruiting
    - Local Institution - 0362
    - Contact:
      
      Site 0362
- Tucumán Province
  - San Miguel de Tucumán, Tucumán Province, Argentina, T4000IHE
    - Not yet recruiting
    - Local Institution - 0420
    - Contact:
      
      Site 0420
Australia
- New South Wales
  - Gosford, New South Wales, Australia, 2250
    - Recruiting
    - Gosford Hospital
    - Contact:
      
      Matthew Chan, Site 0360
      
      Phone Number: +61243209890
  - Penrith, New South Wales, Australia, 2750
    - Not yet recruiting
    - Local Institution - 0176
    - Contact:
      
      Site 0176
- South Australia
  - Elizabeth Vale, South Australia, Australia, 5112
    - Recruiting
    - Lyell McEwin Hospital
    - Contact:
      
      Joanne Tang, Site 0154
      
      Phone Number: 08 7117 7265
- Victoria
  - Epping, Victoria, Australia, 3076
    - Not yet recruiting
    - Local Institution - 0201
    - Contact:
      
      Site 0201
  - Mount Waverley, Victoria, Australia, 3149
    - Recruiting
    - Grampians Health
    - Contact:
      
      Wasek Faisal, Site 0221
      
      Phone Number: 61(03)53208500
- Western Australia
  - Joondalup, Western Australia, Australia, 6027
    - Recruiting
    - Joondalup Health Campus
    - Contact:
      
      Arman Hasani, Site 0038
      
      Phone Number: +61 8 9400 9897
Austria
- - Feldkirch, Austria, 6800
    - Not yet recruiting
    - Local Institution - 0196
    - Contact:
      
      Site 0196
  - Sankt Pölten, Austria, 3100
    - Not yet recruiting
    - Local Institution - 0095
    - Contact:
      
      Site 0095
- Upper Austria
  - Linz, Upper Austria, Austria, 4021
    - Not yet recruiting
    - Local Institution - 0064
    - Contact:
      
      Site 0064
Belgium
- - Edegem, Belgium, 2650
    - Not yet recruiting
    - Local Institution - 0188
    - Contact:
      
      Site 0188
- Antwerpen
  - Brasschaat, Antwerpen, Belgium, 2930
    - Not yet recruiting
    - Local Institution - 0345
    - Contact:
      
      Site 0345
- Bruxelles-Capitale, Région de
  - Auderghem, Bruxelles-Capitale, Région de, Belgium, 1160
    - Not yet recruiting
    - Local Institution - 0333
    - Contact:
      
      Site 0333
- Vlaams-Brabant
  - Leuven, Vlaams-Brabant, Belgium, 3000
    - Not yet recruiting
    - Local Institution - 0109
    - Contact:
      
      Site 0109
Brazil
- - São Paulo, Brazil, 01452-000
    - Not yet recruiting
    - Local Institution - 0163
    - Contact:
      
      Site 0163
- Ceará
  - Fortaleza, Ceará, Brazil, 60336-045
    - Not yet recruiting
    - Local Institution - 0148
    - Contact:
      
      Site 0148
- Rio Grande do Norte
  - Natal/RN, Rio Grande do Norte, Brazil, 59062-000
    - Not yet recruiting
    - Local Institution - 0066
    - Contact:
      
      Site 0066
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
    - Not yet recruiting
    - Local Institution - 0245
    - Contact:
      
      Site 0245
- São Paulo
  - Barretos, São Paulo, Brazil, 14784
    - Not yet recruiting
    - Local Institution - 0085
    - Contact:
      
      Site 0085
  - São Paulo, São Paulo, Brazil, 01509-010
    - Not yet recruiting
    - Local Institution - 0375
    - Contact:
      
      Site 0375
  - Taubaté, São Paulo, Brazil, 12030-200
    - Not yet recruiting
    - Local Institution - 0090
    - Contact:
      
      Site 0090
Bulgaria
- - Rousse, Bulgaria, 7002
    - Not yet recruiting
    - Local Institution - 0202
    - Contact:
      
      Site 0202
  - Sofia, Bulgaria, 1431
    - Not yet recruiting
    - Local Institution - 0326
    - Contact:
      
      Site 0326
  - Sofia, Bulgaria, 1527
    - Not yet recruiting
    - Local Institution - 0047
    - Contact:
      
      Site 0047
  - Sofia, Bulgaria, 1680
    - Not yet recruiting
    - Local Institution - 0325
    - Contact:
      
      Site 0325
Canada
- British Columbia
  - Prince George, British Columbia, Canada, V2M7E9
    - Not yet recruiting
    - Local Institution - 0411
    - Contact:
      
      Site 0411
- New Brunswick
  - Fredericton, New Brunswick, Canada, E3B4R3
    - Not yet recruiting
    - Local Institution - 0413
    - Contact:
      
      Site 0413
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 3A7
    - Not yet recruiting
    - Local Institution - 0002
    - Contact:
      
      Site 0002
- Ontario
  - Oshawa, Ontario, Canada, L1G2B9
    - Not yet recruiting
    - Local Institution - 0414
    - Contact:
      
      Site 0414
  - Ottawa, Ontario, Canada, K1H 8L6
    - Not yet recruiting
    - Local Institution - 0178
    - Contact:
      
      Site 0178
  - Toronto, Ontario, Canada, M6R 1B5
    - Not yet recruiting
    - Local Institution - 0156
    - Contact:
      
      Site 0156
Chile
- - Concepción, Chile, 4070196
    - Not yet recruiting
    - Local Institution - 0293
    - Contact:
      
      Site 0293
  - Independencia, Chile, 8380455
    - Not yet recruiting
    - Local Institution - 0150
    - Contact:
      
      Site 0150
- AN
  - Antofagasta, AN, Chile, 1240000
    - Not yet recruiting
    - Local Institution - 0361
    - Contact:
      
      Site 0361
- Arica y Parinacota Region
  - Las Condes, Arica y Parinacota Region, Chile, 7560908
    - Not yet recruiting
    - Local Institution - 0302
    - Contact:
      
      Site 0302
- Santiago Metropolitan
  - Santiago, Santiago Metropolitan, Chile, 7510032
    - Not yet recruiting
    - Local Institution - 0222
    - Contact:
      
      Site 0222
  - Santiago, Santiago Metropolitan, Chile, 8420383
    - Not yet recruiting
    - Local Institution - 0199
    - Contact:
      
      Site 0199
China
- - Beijing, China, 100021
    - Not yet recruiting
    - Local Institution - 0113
    - Contact:
      
      Site 0113
  - Shanghai Shi, China, 200030
    - Not yet recruiting
    - Local Institution - 0122
    - Contact:
      
      Site 0122
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100142
    - Not yet recruiting
    - Local Institution - 0175
    - Contact:
      
      Site 0175
- Fujian
  - Fuzhou, Fujian, China, 350014
    - Not yet recruiting
    - Local Institution - 0167
    - Contact:
      
      Site 0167
  - Xiamen, Fujian, China, 361003
    - Not yet recruiting
    - Local Institution - 0141
    - Contact:
      
      Site 0141
  - Zhangzhou, Fujian, China, 363000
    - Not yet recruiting
    - Local Institution - 0327
    - Contact:
      
      Site 0327
- Guangdong
  - Guangzhou, Guangdong, China, 510515
    - Not yet recruiting
    - Local Institution - 0312
    - Contact:
      
      Site 0312
  - Shantou, Guangdong, China, 515041
    - Recruiting
    - Cancer Hospital of Shantou University Medical College
    - Contact:
      
      Wen Lin, Site 0210
      
      Phone Number: 13612388011
- Guangxi
  - Nanning, Guangxi, China, 530021
    - Recruiting
    - Guangxi Medical University Affiliated Tumor Hospital
    - Contact:
      
      Shaozhang Zhou, Site 0255
      
      Phone Number: 8613977183708
- Heilongjiang
  - Harbin, Heilongjiang, China, 150081
    - Not yet recruiting
    - Local Institution - 0317
    - Contact:
      
      Site 0317
- Henan
  - Zhengzhou, Henan, China, 450008
    - Not yet recruiting
    - Local Institution - 0046
    - Contact:
      
      Site 0046
- Hunan
  - Changsha, Hunan, China, 410013
    - Not yet recruiting
    - Local Institution - 0004
    - Contact:
      
      Site 0004
- Jiangsu
  - Nanjing, Jiangsu, China, 210000
    - Not yet recruiting
    - Local Institution - 0117
    - Contact:
      
      Site 0117
  - Nanjing, Jiangsu, China, 210009
    - Not yet recruiting
    - Local Institution - 0316
    - Contact:
      
      Site 0316
- Jiangxi
  - Nanchang, Jiangxi, China, 330006
    - Not yet recruiting
    - Local Institution - 0023
    - Contact:
      
      Site 0023
- Liaoning
  - Shenyang, Liaoning, China, 110042
    - Not yet recruiting
    - Local Institution - 0177
    - Contact:
      
      Site 0177
- Shaanxi
  - Xi'an, Shaanxi, China, 710038
    - Not yet recruiting
    - Local Institution - 0014
    - Contact:
      
      Site 0014
- Shandong
  - Jinan, Shandong, China, 250117
    - Not yet recruiting
    - Local Institution - 0359
    - Contact:
      
      Site 0359
  - Linyi, Shandong, China, 276001
    - Not yet recruiting
    - Local Institution - 0123
    - Contact:
      
      Site 0123
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200120
    - Recruiting
    - Shanghai East Hospital
    - Contact:
      
      Caicun Zhou, Site 0185
      
      Phone Number: 8613301825532
  - Shanghai Shi, Shanghai Municipality, China, 201700
    - Not yet recruiting
    - Local Institution - 0212
    - Contact:
      
      Site 0212
- Sichuan
  - Chengdu, Sichuan, China, 610041
    - Not yet recruiting
    - Local Institution - 0246
    - Contact:
      
      Site 0246
- Zhejiang
  - Hangzhou, Zhejiang, China, 310016
    - Not yet recruiting
    - Local Institution - 0183
    - Contact:
      
      Site 0183
  - Hangzhou, Zhejiang, China, 310052
    - Not yet recruiting
    - Local Institution - 0089
    - Contact:
      
      Site 0089
Colombia
- - Bogotá, Colombia
    - Not yet recruiting
    - Local Institution - 0218
    - Contact:
      
      Site 0218
  - Medellín, Colombia, 050034
    - Not yet recruiting
    - Local Institution - 0307
    - Contact:
      
      Site 0307
- Antioquia
  - Rionegro, Antioquia, Colombia, 054047
    - Not yet recruiting
    - Local Institution - 0310
    - Contact:
      
      Site 0310
- Atlántico
  - Barranquilla, Atlántico, Colombia, 80020
    - Not yet recruiting
    - Local Institution - 0328
    - Contact:
      
      Site 0328
Czechia
- - Hradec Králové, Czechia, 500 05
    - Not yet recruiting
    - Local Institution - 0243
    - Contact:
      
      Site 0243
  - Olomouc, Czechia, 77520
    - Not yet recruiting
    - Local Institution - 0236
    - Contact:
      
      Site 0236
- Moravian-Silesian
  - Ostrava, Moravian-Silesian, Czechia, 70384
    - Not yet recruiting
    - Local Institution - 0092
    - Contact:
      
      Site 0092
- Plzeň Region
  - Pilsen, Plzeň Region, Czechia, 305 99
    - Not yet recruiting
    - Local Institution - 0129
    - Contact:
      
      Site 0129
Finland
- - Tampere, Finland, 33521
    - Not yet recruiting
    - Local Institution - 0171
    - Contact:
      
      Site 0171
  - Vaasa, Finland, 65130
    - Not yet recruiting
    - Local Institution - 0126
    - Contact:
      
      Site 0126
- Northern Savonia
  - Kuopio, Northern Savonia, Finland, 70200
    - Not yet recruiting
    - Local Institution - 0060
    - Contact:
      
      Site 0060
France
- - Dijon, France, 21079
    - Not yet recruiting
    - Local Institution - 0397
    - Contact:
      
      Site 0397
  - Limoges, France, 87042
    - Not yet recruiting
    - Local Institution - 0054
    - Contact:
      
      Site 0054
  - Marseille, France, 13915
    - Withdrawn
    - Local Institution - 0151
  - Paris, France, 75679
    - Not yet recruiting
    - Local Institution - 0206
    - Contact:
      
      Site 0206
  - Quimper, France, 29000
    - Not yet recruiting
    - Local Institution - 0390
    - Contact:
      
      Site 0390
  - Reims, France, 51726
    - Not yet recruiting
    - Local Institution - 0400
    - Contact:
      
      Site 0400
- Alpes-Maritimes
  - Nice, Alpes-Maritimes, France, 06189
    - Not yet recruiting
    - Local Institution - 0398
    - Contact:
      
      Site 0398
- Aquitaine
  - Pessac, Aquitaine, France, 33600
    - Not yet recruiting
    - Local Institution - 0130
    - Contact:
      
      Site 0130
- Hauts-de-France
  - Lille, Hauts-de-France, France, 59037
    - Withdrawn
    - Local Institution - 0162
- Hérault
  - Montpellier, Hérault, France, 34298
    - Withdrawn
    - Local Institution - 0239
- Isère
  - La Tronche, Isère, France, 38700
    - Not yet recruiting
    - Local Institution - 0144
    - Contact:
      
      Site 0144
- Loire-Atlantique
  - Saint-Herblain, Loire-Atlantique, France, 44805
    - Not yet recruiting
    - Local Institution - 0057
    - Contact:
      
      Site 0057
- Midi-Pyrénées
  - Toulouse, Midi-Pyrénées, France, 31400
    - Withdrawn
    - Local Institution - 0059
- Île-de-France Region
  - Paris, Île-de-France Region, France, 75014
    - Not yet recruiting
    - Local Institution - 0207
    - Contact:
      
      Site 0207
Germany
- - Berlin, Germany, 14165
    - Not yet recruiting
    - Local Institution - 0231
    - Contact:
      
      Site 0231
  - Braunschweig, Germany, 38114
    - Not yet recruiting
    - Local Institution - 0158
    - Contact:
      
      Site 0158
  - Erfurt, Germany, 99089
    - Not yet recruiting
    - Local Institution - 0157
    - Contact:
      
      Site 0157
  - Essen, Germany, 45136
    - Not yet recruiting
    - Local Institution - 0073
    - Contact:
      
      Site 0073
  - Gera, Germany, 07548
    - Not yet recruiting
    - Local Institution - 0103
    - Contact:
      
      Site 0103
  - Göttingen, Germany, 37075
    - Withdrawn
    - Local Institution - 0071
  - Kaiserslautern, Germany, 67655
    - Not yet recruiting
    - Local Institution - 0357
    - Contact:
      
      Site 0357
  - Münster, Germany, 48149
    - Not yet recruiting
    - Local Institution - 0264
    - Contact:
      
      Site 0264
  - Sindelfingen, Germany, 71065
    - Withdrawn
    - Local Institution - 0083
- Baden-Wurttemberg
  - Wangen, Baden-Wurttemberg, Germany, 88239
    - Not yet recruiting
    - Local Institution - 0072
    - Contact:
      
      Site 0072
- Bavaria
  - Landshut, Bavaria, Germany, 84036
    - Not yet recruiting
    - Local Institution - 0270
    - Contact:
      
      Site 0270
  - Rosenheim, Bavaria, Germany, 83022
    - Not yet recruiting
    - Local Institution - 0024
    - Contact:
      
      Site 0024
- North Rhine-Westphalia
  - Cologne, North Rhine-Westphalia, Germany, 51109
    - Not yet recruiting
    - Local Institution - 0432
    - Contact:
      
      Site 0432
  - Dortmund, North Rhine-Westphalia, Germany, 44263
    - Not yet recruiting
    - Local Institution - 0428
    - Contact:
      
      Site 0428
  - Solingen, North Rhine-Westphalia, Germany, 42699
    - Not yet recruiting
    - Local Institution - 0187
    - Contact:
      
      Site 0187
- Schleswig-Holstein
  - Kiel, Schleswig-Holstein, Germany, 24105
    - Not yet recruiting
    - Local Institution - 0172
    - Contact:
      
      Site 0172
Hungary
- - Budapest, Hungary, 1121
    - Not yet recruiting
    - Local Institution - 0240
    - Contact:
      
      Site 0240
  - Farkasgyepű, Hungary, 8582
    - Not yet recruiting
    - Local Institution - 0012
    - Contact:
      
      Site 0012
  - Mátraháza, Hungary, 3233
    - Not yet recruiting
    - Local Institution - 0244
    - Contact:
      
      Site 0244
  - Szolnok, Hungary, 5004
    - Not yet recruiting
    - Local Institution - 0241
    - Contact:
      
      Site 0241
India
- - Delhi, India, 110029
    - Not yet recruiting
    - Local Institution - 0078
    - Contact:
      
      Site 0078
  - Pune, India, 411001
    - Not yet recruiting
    - Local Institution - 0036
    - Contact:
      
      Site 0036
- Andhra Pradesh
  - Eluru, Andhra Pradesh, India, 534002
    - Not yet recruiting
    - Local Institution - 0303
    - Contact:
      
      Site 0303
  - Visakhapatnam, Andhra Pradesh, India, 530053
    - Not yet recruiting
    - Local Institution - 0319
    - Contact:
      
      Site 0319
- Gujarat
  - Goraj, Gujarat, India, 391760
    - Not yet recruiting
    - Local Institution - 0427
    - Contact:
      
      Site 0427
- Maharashtra
  - Mumbai, Maharashtra, India, 400012
    - Not yet recruiting
    - Local Institution - 0219
    - Contact:
      
      Site 0219
  - Mumbai, Maharashtra, India, 400036
    - Not yet recruiting
    - Local Institution - 0015
    - Contact:
      
      Site 0015
  - Nagpur, Maharashtra, India, 440001
    - Not yet recruiting
    - Local Institution - 0008
    - Contact:
      
      Site 0008
- National Capital Territory of Delhi
  - Dwarka, National Capital Territory of Delhi, India, 110075
    - Not yet recruiting
    - Local Institution - 0125
    - Contact:
      
      Site 0125
- Telangana
  - Hyderabad, Telangana, India, 500033
    - Not yet recruiting
    - Local Institution - 0020
    - Contact:
      
      Site 0020
Italy
- - Aviano (PN), Italy, 33081
    - Not yet recruiting
    - Local Institution - 0194
    - Contact:
      
      Site 0194
  - Candiolo, Italy, 10060
    - Not yet recruiting
    - Local Institution - 0032
    - Contact:
      
      Site 0032
  - Genova, Italy, 16132
    - Not yet recruiting
    - Local Institution - 0111
    - Contact:
      
      Site 0111
  - Milan, Italy, 20132
    - Not yet recruiting
    - Local Institution - 0033
    - Contact:
      
      Site 0033
  - Naples, Italy, 80131
    - Not yet recruiting
    - Local Institution - 0040
    - Contact:
      
      Site 0040
- Emilia-Romagna
  - Ferrara (Cona), Emilia-Romagna, Italy, 44124
    - Not yet recruiting
    - Local Institution - 0281
    - Contact:
      
      Site 0281
- Piedmont
  - Novara, Piedmont, Italy, 28100
    - Not yet recruiting
    - Local Institution - 0174
    - Contact:
      
      Site 0174
- Sicily
  - Catania, Sicily, Italy, 95123
    - Not yet recruiting
    - Local Institution - 0279
    - Contact:
      
      Site 0279
Japan
- - Hamamatsu, Japan, 431-3192
    - Not yet recruiting
    - Local Institution - 0253
    - Contact:
      
      Site 0253
  - Hirakata-shi, Japan, 573-1191
    - Not yet recruiting
    - Local Institution - 0252
    - Contact:
      
      Site 0252
  - Hiroshima, Japan, 734-8530
    - Not yet recruiting
    - Local Institution - 0341
    - Contact:
      
      Site 0341
  - Yokohama, Japan, 101-0047
    - Not yet recruiting
    - Local Institution - 0249
    - Contact:
      
      Site 0249
- Aichi-ken
  - Toyohashi, Aichi-ken, Japan, 441-8570
    - Recruiting
    - Toyohashi Municipal Hospital
    - Contact:
      
      Yasushi Makino, Site 0055
      
      Phone Number: +81-532-33-6111
- Aomori
  - Aomori, Aomori, Japan, 0308553
    - Not yet recruiting
    - Local Institution - 0363
    - Contact:
      
      Site 0363
- Chiba
  - Funabashi, Chiba, Japan, 273-0853
    - Recruiting
    - Funabashi Municipal Medical Center
    - Contact:
      
      Sukeyuki Nakamura, Site 0258
      
      Phone Number: +81-47-438-3321
- Ehime
  - Tōon, Ehime, Japan, 791-0295
    - Not yet recruiting
    - Local Institution - 0256
    - Contact:
      
      Site 0256
- Hokkaido
  - Sapporo, Hokkaido, Japan, 060-0063
    - Not yet recruiting
    - Local Institution - 0417
    - Contact:
      
      Site 0417
- Hyōgo
  - Nishinomiya, Hyōgo, Japan, 663-8501
    - Recruiting
    - Hyogo Medical University Hospital
    - Contact:
      
      Takashi Kijima, Site 0251
      
      Phone Number: 81798456111
- Ishikawa-ken
  - Kanazawa, Ishikawa-ken, Japan, 920-8530
    - Recruiting
    - Ishikawa Prefectural Central Hospital
    - Contact:
      
      Takashi Sone, Site 0056
      
      Phone Number: 81762378211
- Kanagawa
  - Kamakura, Kanagawa, Japan, 247-8533
    - Recruiting
    - Shonan Kamakura General Hospital
    - Contact:
      
      Tomoya Fukui, Site 0259
      
      Phone Number: 0467-46-1717
- Kumamoto
  - Kumamoto, Kumamoto, Japan, 861-4193
    - Not yet recruiting
    - Local Institution - 0248
    - Contact:
      
      Site 0248
- Miyagi
  - Sendai, Miyagi, Japan, 980-0873
    - Not yet recruiting
    - Local Institution - 0254
    - Contact:
      
      Site 0254
  - Sendai, Miyagi, Japan, 980-8574
    - Not yet recruiting
    - Local Institution - 0257
    - Contact:
      
      Site 0257
- Osaka
  - Sakai, Osaka, Japan, 590-0197
    - Recruiting
    - Kindai University Hospital
    - Contact:
      
      Hidetoshi Hayashi, Site 0250
      
      Phone Number: 81723681184
- Saitama
  - Koshigaya, Saitama, Japan, 343-0845
    - Not yet recruiting
    - Local Institution - 0247
    - Contact:
      
      Site 0247
- Saitama-Pref
  - Hidaka, Saitama-Pref, Japan, 350-1298
    - Not yet recruiting
    - Local Institution - 0166
    - Contact:
      
      Site 0166
Malaysia
- - Kuala Lumpur, Malaysia, 50603
    - Not yet recruiting
    - Local Institution - 0277
    - Contact:
      
      Site 0277
- Pulau Pinang
  - George Town, Pulau Pinang, Malaysia, 10990
    - Not yet recruiting
    - Local Institution - 0275
    - Contact:
      
      Site 0275
- Sarawak
  - Kuching, Sarawak, Malaysia, 93586
    - Not yet recruiting
    - Local Institution - 0271
    - Contact:
      
      Site 0271
Mexico
- - Mexico City, Mexico, 14210
    - Not yet recruiting
    - Local Institution - 0385
    - Contact:
      
      Site 0385
  - Oaxaca City, Mexico, 68020
    - Not yet recruiting
    - Local Institution - 0097
    - Contact:
      
      Site 0097
  - Querétaro, Mexico, 76000
    - Not yet recruiting
    - Local Institution - 0124
    - Contact:
      
      Site 0124
- Jalisco
  - Zapopan, Jalisco, Mexico, 45050
    - Not yet recruiting
    - Local Institution - 0070
    - Contact:
      
      Site 0070
- Mexico City
  - Mexico City, Mexico City, Mexico, 04700
    - Not yet recruiting
    - Local Institution - 0075
    - Contact:
      
      Site 0075
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64623
    - Not yet recruiting
    - Local Institution - 0386
    - Contact:
      
      Site 0386
Netherlands
- - 's-Hertogenbosch, Netherlands, 5211 NL
    - Not yet recruiting
    - Local Institution - 0100
    - Contact:
      
      Site 0100
  - Amersfoort, Netherlands, 3813 TZ
    - Not yet recruiting
    - Local Institution - 0161
    - Contact:
      
      Site 0161
  - Deventer, Netherlands, 7400 GC
    - Withdrawn
    - Local Institution - 0261
  - Tilburg, Netherlands, 5022 GC
    - Not yet recruiting
    - Local Institution - 0094
    - Contact:
      
      Site 0094
- Gelderland
  - Nijmegen, Gelderland, Netherlands, 6525 GA
    - Not yet recruiting
    - Local Institution - 0110
    - Contact:
      
      Site 0110
- North Brabant
  - Breda, North Brabant, Netherlands, 4818 CK
    - Withdrawn
    - Local Institution - 0286
Norway
- Akershus
  - Grålum, Akershus, Norway, 1714
    - Not yet recruiting
    - Local Institution - 0164
    - Contact:
      
      Site 0164
- Buskerud
  - Drammen, Buskerud, Norway, 3004
    - Not yet recruiting
    - Local Institution - 0050
    - Contact:
      
      Site 0050
Peru
- - Lima, Peru, 27
    - Not yet recruiting
    - Local Institution - 0155
    - Contact:
      
      Site 0155
  - Lima, Peru, Lima 41
    - Not yet recruiting
    - Local Institution - 0296
    - Contact:
      
      Site 0296
- Lima region
  - San Borja, Lima region, Peru, 15034
    - Not yet recruiting
    - Local Institution - 0121
    - Contact:
      
      Site 0121
Poland
- - Katowice, Poland, 40-514
    - Withdrawn
    - Local Institution - 0105
  - Katowice, Poland, 40-519
    - Withdrawn
    - Local Institution - 0329
  - Lodz, Poland, 93-338
    - Withdrawn
    - Local Institution - 0186
- Opole Voivodeship
  - Opole, Opole Voivodeship, Poland, 45-061
    - Withdrawn
    - Local Institution - 0041
- Podkarpackie Voivodeship
  - Przemyśl, Podkarpackie Voivodeship, Poland, 37-700
    - Withdrawn
    - Local Institution - 0227
Portugal
- - Braga, Portugal, 4710-243
    - Not yet recruiting
    - Local Institution - 0294
    - Contact:
      
      Site 0294
  - Lisbon, Portugal, 1769-001
    - Not yet recruiting
    - Local Institution - 0278
    - Contact:
      
      Site 0278
Romania
- - Baloteşti, Romania, 77015
    - Not yet recruiting
    - Local Institution - 0191
    - Contact:
      
      Site 0191
  - Bucharest, Romania, 020335
    - Not yet recruiting
    - Local Institution - 0044
    - Contact:
      
      Site 0044
  - Bucharest, Romania, 030171
    - Not yet recruiting
    - Local Institution - 0049
    - Contact:
      
      Site 0049
  - Bucharest, Romania, 050098
    - Not yet recruiting
    - Local Institution - 0136
    - Contact:
      
      Site 0136
  - Cluj-Napoca, Romania, 400015
    - Not yet recruiting
    - Local Institution - 0209
    - Contact:
      
      Site 0209
  - Craiova, Romania, 200347
    - Not yet recruiting
    - Local Institution - 0084
    - Contact:
      
      Site 0084
  - Floresti/ Cluj, Romania, 407280
    - Not yet recruiting
    - Local Institution - 0132
    - Contact:
      
      Site 0132
  - Iași, Romania, 700106
    - Not yet recruiting
    - Local Institution - 0127
    - Contact:
      
      Site 0127
  - Iași, Romania, 700483
    - Not yet recruiting
    - Local Institution - 0068
    - Contact:
      
      Site 0068
Singapore
- - Singapore, Singapore, 169610
    - Not yet recruiting
    - Local Institution - 0267
    - Contact:
      
      Site 0267
  - Singapore, Singapore, 308442
    - Not yet recruiting
    - Local Institution - 0269
    - Contact:
      
      Site 0269
South Korea
- Kyǒngsangnam-do
  - Busan, Kyǒngsangnam-do, South Korea, 50612
    - Recruiting
    - Pusan National University Yangsan Hospital
    - Contact:
      
      Seong Hoon Yoon, Site 0342
      
      Phone Number: 82-10-2870-9389
- Seoul-teukbyeolsi [Seoul]
  - Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05030
    - Recruiting
    - Konkuk University Medical Center
    - Contact:
      
      Kyeyoung Lee, Site 0343
      
      Phone Number: +821088963916
- Taegu-Kwangyǒkshi
  - Deagu, Taegu-Kwangyǒkshi, South Korea, 41404
    - Recruiting
    - Kyungpook National University Chilgok Hospital
    - Contact:
      
      Shin Yup Lee, Site 0336
      
      Phone Number: 82-10-6516-1694
- Taejǒn-Kwangyǒkshi
  - Junggu, Taejǒn-Kwangyǒkshi, South Korea, 35015
    - Recruiting
    - Chungnam national university hospital
    - Contact:
      
      Jeong Eun Lee, Site 0335
Spain
- - Barakaldo, Spain, 48903
    - Not yet recruiting
    - Local Institution - 0074
    - Contact:
      
      Site 0074
  - Barcelona, Spain, 08003
    - Not yet recruiting
    - Local Institution - 0009
    - Contact:
      
      Site 0009
  - Barcelona, Spain, 08041
    - Not yet recruiting
    - Local Institution - 0142
    - Contact:
      
      Site 0142
  - Jaén, Spain, 23007
    - Not yet recruiting
    - Local Institution - 0099
    - Contact:
      
      Site 0099
  - Madrid, Spain, 28006
    - Not yet recruiting
    - Local Institution - 0266
    - Contact:
      
      Site 0266
  - Madrid, Spain, 28040
    - Not yet recruiting
    - Local Institution - 0021
    - Contact:
      
      Site 0021
  - Madrid, Spain, 28041
    - Not yet recruiting
    - Local Institution - 0179
    - Contact:
      
      Site 0179
  - Murcia, Spain, 30008
    - Not yet recruiting
    - Local Institution - 0263
    - Contact:
      
      Site 0263
- Málaga
  - Málaga, Málaga, Spain, 29010
    - Not yet recruiting
    - Local Institution - 0181
    - Contact:
      
      Site 0181
Sweden
- - Gävle, Sweden, 801 87
    - Not yet recruiting
    - Local Institution - 0010
    - Contact:
      
      Site 0010
- Stockholm County
  - Stockholm, Stockholm County, Sweden, 17176
    - Not yet recruiting
    - Local Institution - 0039
    - Contact:
      
      Site 0039
Switzerland
- - Lausanne, Switzerland, 1011
    - Not yet recruiting
    - Local Institution - 0399
    - Contact:
      
      Site 0399
  - Sankt Gallen, Switzerland, 9007
    - Withdrawn
    - Local Institution - 0053
  - Thun, Switzerland, 3600
    - Not yet recruiting
    - Local Institution - 0019
    - Contact:
      
      Site 0019
  - Villars-sur-Glâne, Switzerland, 1752
    - Not yet recruiting
    - Local Institution - 0262
    - Contact:
      
      Site 0262
Taiwan
- - Chiayi City, Taiwan, 60090
    - Not yet recruiting
    - Local Institution - 0203
    - Contact:
      
      Site 0203
  - Kaohsiung City, Taiwan, 82445
    - Not yet recruiting
    - Local Institution - 0387
    - Contact:
      
      Site 0387
  - New Taipei City, Taiwan, 220
    - Not yet recruiting
    - Local Institution - 0035
    - Contact:
      
      Site 0035
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Chang Gung Medical Foundation-Linkou Branch
    - Contact:
      
      Cheng-Ta Yang, Site 0388
      
      Phone Number: 886332812008468
- Kaohsiung
  - Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
    - Recruiting
    - Chang Gung Memorial Hospital at Kaohsiung
    - Contact:
      
      Kuo-Tung Huang, Site 0389
      
      Phone Number: 886773171238199
Thailand
- - Bangkok, Thailand, 10700
    - Not yet recruiting
    - Local Institution - 0272
    - Contact:
      
      Site 0272
  - Chiang Mai, Thailand, 50200
    - Not yet recruiting
    - Local Institution - 0405
    - Contact:
      
      Site 0405
  - Khon Kaen, Thailand, 40002
    - Not yet recruiting
    - Local Institution - 0273
    - Contact:
      
      Site 0273
  - Songkhla, Thailand, 90110
    - Not yet recruiting
    - Local Institution - 0274
    - Contact:
      
      Site 0274
Turkey (Türkiye)
- - Adana, Turkey (Türkiye), 01123
    - Not yet recruiting
    - Local Institution - 0242
    - Contact:
      
      Site 0242
  - Adana, Turkey (Türkiye), 1370
    - Not yet recruiting
    - Local Institution - 0091
    - Contact:
      
      Site 0091
  - Ankara, Turkey (Türkiye), 06800
    - Not yet recruiting
    - Local Institution - 0415
    - Contact:
      
      Site 0415
  - Antalya, Turkey (Türkiye), 7050
    - Not yet recruiting
    - Local Institution - 0118
    - Contact:
      
      Site 0118
  - Cordaleo, Turkey (Türkiye), 35000
    - Not yet recruiting
    - Local Institution - 0235
    - Contact:
      
      Site 0235
  - Istanbul, Turkey (Türkiye), 34214
    - Not yet recruiting
    - Local Institution - 0107
    - Contact:
      
      Site 0107
  - Istanbul, Turkey (Türkiye), 34295
    - Not yet recruiting
    - Local Institution - 0017
    - Contact:
      
      Site 0017
  - Istanbul, Turkey (Türkiye), 34732
    - Not yet recruiting
    - Local Institution - 0133
    - Contact:
      
      Site 0133
  - Istanbul, Turkey (Türkiye), 34899
    - Not yet recruiting
    - Local Institution - 0367
    - Contact:
      
      Site 0367
  - Izmir, Turkey (Türkiye), 35110
    - Not yet recruiting
    - Local Institution - 0364
    - Contact:
      
      Site 0364
  - Çankaya, Turkey (Türkiye), 06680
    - Not yet recruiting
    - Local Institution - 0238
    - Contact:
      
      Site 0238
United Kingdom
- - Cambridge, United Kingdom, CB2 2QQ
    - Not yet recruiting
    - Local Institution - 0114
    - Contact:
      
      Site 0114
  - Cardiff, United Kingdom, CF14 2TL
    - Recruiting
    - Velindre Cancer Centre
    - Contact:
      
      paul shaw, Site 0182
      
      Phone Number: 02920615888
  - Guildford, United Kingdom, GU2 7XX
    - Not yet recruiting
    - Local Institution - 0007
    - Contact:
      
      Site 0007
  - London, United Kingdom, SW3 6JJ
    - Recruiting
    - Royal Marsden Hospital (Chelsea)
    - Contact:
      
      Sanjaykumar Popat, Site 0087
      
      Phone Number: 00442078082132
  - Wolverhampton, United Kingdom, WV10 0QP
    - Recruiting
    - Royal Wolverhampton Nhs Trust
    - Contact:
      
      Talha Hafeez, Site 0371
      
      Phone Number: +441902307999
- Aberdeenshire
  - Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN
    - Not yet recruiting
    - Local Institution - 0365
    - Contact:
      
      Site 0365
- Cleveland
  - Middlesbrough, Cleveland, United Kingdom, TS4 3BW
    - Withdrawn
    - Local Institution - 0112
- East
  - Norwich, East, United Kingdom, NR47UY
    - Not yet recruiting
    - Local Institution - 0426
    - Contact:
      
      Site 0426
- South East
  - Sutton, South East, United Kingdom, SM25PT
    - Recruiting
    - The Royal Marsden NHS Foundation Trust
    - Contact:
      
      Sanjaykumar Popat, Site 0410
      
      Phone Number: 00442078082132
United States
- Alabama
  - Daphne, Alabama, United States, 36526
    - Recruiting
    - Southern Cancer Center Pc
    - Contact:
      
      Michael Meshad, Site 0348
      
      Phone Number: 111-111-1111
- Arizona
  - Bullhead City, Arizona, United States, 86442
    - Not yet recruiting
    - Local Institution - 0424
    - Contact:
      
      Site 0424
  - Glendale, Arizona, United States, 85304
    - Not yet recruiting
    - Local Institution - 0391
    - Contact:
      
      Site 0391
- California
  - Anaheim, California, United States, 92801
    - Not yet recruiting
    - Local Institution - 0407
    - Contact:
      
      Site 0407
  - Beverly Hills, California, United States, 90211
    - Not yet recruiting
    - Local Institution - 0352
    - Contact:
      
      Site 0352
  - Fountain Valley, California, United States, 92708
    - Recruiting
    - Orange Coast Memorial Medical Center
    - Contact:
      
      Amol Rao, Site 0299
      
      Phone Number: 510673-1293
  - Los Alamitos, California, United States, 90720
    - Not yet recruiting
    - Local Institution - 0027
    - Contact:
      
      Site 0027
  - Los Angeles, California, United States, 90095
    - Not yet recruiting
    - Local Institution - 0422
    - Contact:
      
      Site 0422
  - Oakland, California, United States, 94611
    - Not yet recruiting
    - Local Institution - 0403
    - Contact:
      
      Site 0403
  - Pleasant Hill, California, United States, 94523
    - Not yet recruiting
    - Local Institution - 0208
    - Contact:
      
      Site 0208
  - Walnut Creek, California, United States, 94598
    - Not yet recruiting
    - Local Institution - 0416
    - Contact:
      
      Site 0416
- Colorado
  - Lakewood, Colorado, United States, 80401
    - Not yet recruiting
    - Local Institution - 0340
    - Contact:
      
      Site 0340
- Florida
  - Clermont, Florida, United States, 34711
    - Recruiting
    - Clermont Oncology Center
    - Contact:
      
      Gopal Kunta, Site 0192
      
      Phone Number: 352-242-1366
  - Coral Springs, Florida, United States, 33321
    - Recruiting
    - Advanced Research
    - Contact:
      
      Sumit Sawhney, Site 0406
      
      Phone Number: 954-302-3120
  - Hialeah, Florida, United States, 33013
    - Recruiting
    - BRP- Hialeah Hospital
    - Contact:
      
      Luis Rangel, Site 0395
      
      Phone Number: 833-489-4968
- Georgia
  - Athens, Georgia, United States, 30607
    - Recruiting
    - University Cancer & Blood Center, LLC
    - Contact:
      
      Frederick Flynt Jr, Site 0396
      
      Phone Number: 706-353-2990
  - Augusta, Georgia, United States, 30912
    - Not yet recruiting
    - Local Institution - 0412
    - Contact:
      
      Site 0412
  - Marietta, Georgia, United States, 30060
    - Recruiting
    - Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
    - Contact:
      
      Walid Shaib, Site 0284
      
      Phone Number: 770-281-5124
- Illinois
  - Urbana, Illinois, United States, 61801
    - Not yet recruiting
    - Local Institution - 0423
    - Contact:
      
      Site 0423
- Indiana
  - Dyer, Indiana, United States, 46311
    - Recruiting
    - Northwest Cancer Centers, P.C.
    - Contact:
      
      Shruti Singh, Site 0409
      
      Phone Number: 219-924-8178
- Missouri
  - Columbia, Missouri, United States, 65201
    - Recruiting
    - Missouri Cancer Associates
    - Contact:
      
      Caleb Smith, Site 0350
- New York
  - Laurelton, New York, United States, 11413
    - Not yet recruiting
    - Local Institution - 0224
    - Contact:
      
      Site 0224
  - New York, New York, United States, 10065
    - Not yet recruiting
    - Local Institution - 0026
    - Contact:
      
      Site 0026
  - Westbury, New York, United States, 11590
    - Not yet recruiting
    - Local Institution - 0214
    - Contact:
      
      Site 0214
- North Carolina
  - Winston-Salem, North Carolina, United States, 27103
    - Not yet recruiting
    - Local Institution - 0283
    - Contact:
      
      Site 0283
- Ohio
  - Cincinnati, Ohio, United States, 45220
    - Not yet recruiting
    - Local Institution - 0383
    - Contact:
      
      Site 0383
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73109
    - Not yet recruiting
    - Local Institution - 0418
    - Contact:
      
      Site 0418
- Pennsylvania
  - Lancaster, Pennsylvania, United States, 17601
    - Not yet recruiting
    - Local Institution - 0288
    - Contact:
      
      Site 0288
  - Pittsburgh, Pennsylvania, United States, 15212
    - Not yet recruiting
    - Local Institution - 0028
    - Contact:
      
      Site 0028
  - York, Pennsylvania, United States, 17403
    - Recruiting
    - WellSpan Oncology Research
    - Contact:
      
      Ikechukwu Akunyili, Site 0344
      
      Phone Number: 717-339-2560
- Texas
  - Galveston, Texas, United States, 77555
    - Not yet recruiting
    - Local Institution - 0376
    - Contact:
      
      Site 0376
  - Houston, Texas, United States, 77025
    - Recruiting
    - Kelsey-Seybold Clinic Main Campus
    - Contact:
      
      Sunil Patel, Site 0353
      
      Phone Number: 713-442-1700
  - San Antonio, Texas, United States, 78217
    - Recruiting
    - Texas Oncology - San Antonio
    - Contact:
      
      Krishna Alluri, Site 0351
      
      Phone Number: 210-656-7177
  - San Antonio, Texas, United States, 78260
    - Not yet recruiting
    - Local Institution - 0381
    - Contact:
      
      Site 0381
- Virginia
  - Richmond, Virginia, United States, 23298
    - Not yet recruiting
    - Local Institution - 0337
    - Contact:
      
      Site 0337
  - Winchester, Virginia, United States, 22601
    - Recruiting
    - Shenandoah Oncology, P.C.
    - Contact:
      
      Michael McCusker Jr., Site 0349
- Washington
  - Spokane, Washington, United States, 99218
    - Not yet recruiting
    - Local Institution - 0384
    - Contact:
      
      Site 0384
- West Virginia
  - Charleston, West Virginia, United States, 25304
    - Not yet recruiting
    - Local Institution - 0339
    - Contact:
      
      Site 0339
- Wisconsin
  - Green Bay, Wisconsin, United States, 54301
    - Not yet recruiting
    - Local Institution - 0380
    - Contact:
      
      Site 0380
  - Marshfield, Wisconsin, United States, 54449
    - Not yet recruiting
    - Local Institution - 0421
    - Contact:
      
      Site 0421

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria

Participants must have a histologically or cytologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) (squamous and nonsquamous) with Stage IIIB/IIIC or Stage IV disease.
Participants must have a programmed death ligand-1 (PD-L1) expression ≥ 50%.
Participants must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Participants must have no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

Exclusion Criteria

Participants must not have any documented actionable genomic alteration (AGA) for which first-line (1L) approved therapies are indicated.
Participants must not have any symptomatic untreated central nervous system (CNS) metastases, leptomeningeal metastases (carcinomatous meningitis) or spinal cord compression.
Participants must not have any significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, or major thrombotic or embolic events or major hemorrhagic events (within 6 months prior to randomization), or significant risk of pulmonary hemorrhage.
Participants must not an active autoimmune disease.
Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Pumitamig	Drug: Pumitamig Specified dose on specified days Other Names: BMS-986545
Active Comparator: Arm B: Pembrolizumab	Drug: Pembrolizumab Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS) Time Frame: Up to approximately 5 years	Up to approximately 5 years
Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Time Frame: Up to approximately 3 years	Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
PFS by investigator according to RECIST v1.1 Time Frame: Up to approximately 3 years	Up to approximately 3 years
Objective Response (OR) by BICR according to RECIST v1.1 Time Frame: Up to approximately 3 years	Up to approximately 3 years
Duration of response (DOR) by BICR according to RECIST v1.1 Time Frame: Up to approximately 3 years	Up to approximately 3 years
Disease control rate (DCR) by BICR according to RECIST v1.1 Time Frame: Up to approximately 3 years	Up to approximately 3 years
Time to Response (TTR) by BICR according to RECIST v1.1 Time Frame: Up to approximately 3 years	Up to approximately 3 years
Time to definitive deterioration (TTDD) based on the Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) defined as the time from randomization until a definitive clinically meaningful worsening in symptoms or in NSCLC-SAQ total score Time Frame: Up to approximately 3 years	Up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

BioNTech SE

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2026

Primary Completion (Estimated)

October 14, 2031

Study Completion (Estimated)

October 14, 2031

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CA266-0002
2025-523586-18 (Other Identifier: EU CT Number)
U1111-1326-9286 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-Small Cell Lung Cancer (NSCLC)

Revolution Medicines, Inc.

Recruiting

Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) (RASolve 301)

Non-Small Cell Lung Cancer | NSCLC | NSCLC (Non-small Cell Lung Cancer) | NSCLC (Advanced Non-small Cell Lung Cancer) | NSCLC (Non-small Cell Lung Carcinoma)

Japan, Netherlands, Hong Kong, United States, United Kingdom, Belgium, Australia, Spain, Germany, Switzerland, Italy, Taiwan, France, Singapore, Poland, South Korea, Puerto Rico, Ireland, New Zealand
H. Lee Moffitt Cancer Center and Research Institute
Nestle Health Science

Withdrawn

Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer

NSCLC | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | NSCLC Stage IIIB | Non-small Cell Lung Cancer Stage IIIB | NSCLC, Stage IIIA | Non-small Cell Lung Cancer Stage ⅢA

United States
Guangzhou University of Traditional Chinese Medicine
Guang'anmen Hospital of China Academy of Chinese Medical Sciences; Beijing... and other collaborators

Not yet recruiting

A Prospective Multicenter Study of the Association Between TCM Syndromes and EGFR-TKI Efficacy in Lung Cancer Patients

Non Small Cell Lung Cancer NSCLC

China
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Recruiting

The Role of DNA and RNA in NGS Analyses for Advaced Stage NSCLC Patients

Non Small Cell Lung Cancer NSCLC

Italy
Massachusetts General Hospital
Summit Therapeutics

Not yet recruiting

Ivonescimab Alone And With Carboplatin/Pemetrexed For NSCLC

Lung Cancer Non Small Cell | Genomic Alterations | Lung Cancer (Non-Small Cell) | Lung Cancer (NSCLC) | Lung Cancer Non-Small Cell Cancer (NSCLC) | Lung Cancer - Non Small Cell

United States
Mythic Therapeutics

Terminated

Clinical Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer | NSCLC | Advanced Non-Small Cell Lung Cancer | NSCLC Stage IV | NSCLC Stage IIIB | Advanced Non-Small Cell Squamous Lung Cancer | Advanced Non-Small Cell Non-Squamous Lung Cancer

United States, Spain, Taiwan, Australia, United Kingdom, France, South Korea
Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb

Recruiting

A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan (NEOREAL)

Non Small Cell Lung Cancer NSCLC

Taiwan
Multitude Therapeutics Inc.

Not yet recruiting

AMT-116 in Combination With Ivosidan in Patients With Lung Cancer

Advanced Non-small Cell Lung Cancer (NSCLC)

China
Pfizer

Not yet recruiting

Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC

Carcinoma | Lung Neoplasms | Non-Small Cell Lung Cancer | Lung Disease | Non-Small-Cell Lung | Carcinoma, Non-Small-Cell Lung (NSCLC) | Non-small Cell Lung Cancer, Squamous | Non-small Cell Lung Cancer, Non-squamous | Lung Cancer (NSCLC)
Technische Universität Dresden
Deutsche Krebshilfe e.V., Bonn (Germany); Universitätsklinikum Köln

Not yet recruiting

Immune-Marker Platform for Patients With Advanced Lung Cancer (IMPALUX)

NSCLC Stage IIIB~IV | NSCLC (Advanced Non-small Cell Lung Cancer) | NSCLC Non-small Cell Lung Cancer

Germany

Clinical Trials on Pembrolizumab

Universitair Ziekenhuis Brussel

Recruiting

A Phase II Clinical Trial on Neo-adjuvant Pembrolizumab in Patients With pT3b-T4a/b cN0M0 Melanoma. (NeoSenti)

Melanoma (Skin Cancer)

Belgium
iLeukon Therapeutics, Inc.

Not yet recruiting

ILKN421H Plus Pembrolizumab in Advanced Non-Small Cell Lung Cancer

Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Sinocelltech Ltd.

Recruiting

A Study to Evaluate the Safety and Tolerability of SCTB14 as First-Line Therapy in Non-Small Cell Lung Cancer.

Non-Small Cell Lung Carcinoma (NSCLC)

China
UNC Lineberger Comprehensive Cancer Center
Exelixis

Not yet recruiting

H&N NEO-COMBAT XL: Neoadjuvant XL-092 (Zanzalintinib) and Pembrolizumab (Keytruda) in Surgically Resectable, HPV Negative Oral Cavity Squamous Cell Carcinoma (OCSCC) (NEO COMBAT XL)

Head and Neck Cancer | Oral Cavity Squamous Cell Carcinoma

United States
Ismail Gögenur
Odense University Hospital; Zealand University Hospital; Aarhus University Hospital and other collaborators

Not yet recruiting

Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer (RESET C2)

Immunotherapy | Pembrolizumab | DMMR Colorectal Cancer | Colon Cancer Stage I | Colon Cancer Stage II/III

Denmark
Yonsei University

Not yet recruiting

A Phase IIb Randomized Clinical Trial of Immune Checkpoint Inhibitor-based Maintenance Therapy in Patients With Advanced Biliary Tract Cancer

Advanced Cancer | Biliary Tract Neoplasms | Immunotherapy

South Korea
Merck Sharp & Dohme LLC

Recruiting

A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participants With Merkel Cell Carcinoma (MK-3475-G21/KEYNOTE-G21)

Lymphoma | Carcinoma, Merkel Cell | Malignant Neoplasm

Japan
Chong Kun Dang Pharmaceutical

Recruiting

Phase Ia/Ib Study of CKD-512 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumors

Advanced Solid Tumors | Metastatic Solid Tumors

South Korea
Flare Therapeutics Inc.
Merck Sharp & Dohme LLC

Recruiting

A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma

Advanced Urothelial Carcinoma | Open Label | Oral Drug Administration

United States
Seda S. Tolu
Incyte Corporation

Recruiting

Amping up With PemJAK

Non-Hodgkin Lymphoma | Peripheral T-cell Lymphoma | Hodgkin Disease Recurrent | Gray Zone Lymphoma | Primary Mediastinal B Cell Lymphoma | Cutaneous T-Cell Lymphomas | Hodgkin Disease Lymphoma | Non-Hodgkin Lymphoma Refractory/ Relapsed

United States

A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)

ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥ 50%.

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Non-Small Cell Lung Cancer (NSCLC)

Clinical Trials on Pembrolizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations