An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC) (CheckMate 227)

October 21, 2025 updated by: Bristol-Myers Squibb

An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2747

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 Locations

  • Argentina
      • Córdoba, Argentina, 5016
        • Local Institution - 0272
      • Córdoba, Argentina, X50004FHP
        • Local Institution - 0297
      • Córdoba, Argentina, 5000
        • Local Institution - 0268
      • Viedma, Argentina, 8500
        • Local Institution - 0177
    • Buenos Aires
      • Berazategui, Buenos Aires, Argentina, 1880
        • Local Institution - 0170
      • Capital Federal, Buenos Aires, Argentina, 1426
        • Local Institution - 0171
      • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, 1181
        • Local Institution - 0172
      • Ciudad de Buenos Aires, Buenos Aires, Argentina, 1025
        • Local Institution - 0176
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Local Institution - 0296
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Local Institution - 0130
  • Australia
      • Murdoch, Australia, 6150
        • Local Institution - 0040
      • North Tamworth, Australia, 2340
        • Local Institution - 0183
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Local Institution - 0182
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Local Institution - 0301
      • Gosford, New South Wales, Australia, 2250
        • Local Institution - 0300
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Local Institution - 0045
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Local Institution - 0046
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Local Institution - 0043
      • Fitzroy, Victoria, Australia, 3065
        • Local Institution - 0042
    • Western Australia
      • Perth, Western Australia, Australia, 6150
        • Local Institution - 0180
  • Austria
      • Graz, Austria, 8036
        • Local Institution - 0241
      • Vienna, Austria, 1090
        • Local Institution - 0240
      • Wels, Austria, 4600
        • Local Institution - 0239
  • Belgium
      • Edegem, Belgium, 2650
        • Local Institution - 0030
      • Ghent, Belgium, 9000
        • Local Institution - 0031
      • Hasselt, Belgium, 3500
        • Local Institution - 0117
      • Sint-Niklaas, Belgium, 9100
        • Local Institution - 0033
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6060
        • Local Institution - 0034
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • Local Institution - 0121
  • Brazil
      • Rio de Janeiro, Brazil, 20231-050
        • Local Institution - 0129
      • São Paulo, Brazil, 01321-001
        • Local Institution - 0144
      • São Paulo, Brazil, 01509-010
        • Local Institution - 0126
      • São Paulo, Brazil, 05403-010
        • Local Institution - 0128
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40170-110
        • Local Institution - 0125
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • Local Institution - 0124
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Local Institution - 0123
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Local Institution - 0127
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0103
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Local Institution - 0290
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Local Institution - 0104
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Local Institution - 0122
      • Québec, Quebec, Canada, G1J 1Z4
        • Local Institution - 0106
      • Québec, Quebec, Canada, G1V 4G5
        • Local Institution - 0302
      • Rimouski, Quebec, Canada, G5L 5T1
        • Local Institution - 0107
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Local Institution - 0291
      • Trois-Rivières, Quebec, Canada, G8Z 3R9
        • Local Institution - 0292
  • Chile
    • Región de Valparaíso
      • Viña del Mar, Región de Valparaíso, Chile, 254 0364
        • Local Institution - 0174
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7500921
        • Local Institution - 0173
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Local Institution - 0131
  • China
      • Changsha, China
        • Local Institution - 0328
      • Hangzhou, China, 310016
        • Local Institution - 0341
      • Kunming, China
        • Local Institution - 0345
      • Shanghai, China, 200030
        • Local Institution - 0337
      • Shantou, China
        • Local Institution - 0374
    • Anhui
      • Hefei, Anhui, China, 230001
        • Local Institution - 0380
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100001
        • Local Institution - 0313
      • Beijing, Beijing Municipality, China, 100021
        • Local Institution - 0315
      • Beijing, Beijing Municipality, China, 100021
        • Local Institution - 0316
      • Beijing, Beijing Municipality, China, 100032
        • Local Institution - 0314
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400037
        • Local Institution - 0365
      • Chongqing, Chongqing Municipality, China, 400038
        • Local Institution - 0364
      • Chongqing, Chongqing Municipality, China, 400042
        • Local Institution - 0378
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Local Institution - 0322
      • Guangzhou, Guangdong, China, 510095
        • Local Institution - 0372
      • Guanzhou, Guangdong, China, 510080
        • Local Institution - 0319
    • Hainan
      • Haikou, Hainan, China, 570311
        • Local Institution - 0323
    • Heilongjiang
      • Haerbin, Heilongjiang, China, 150081
        • Local Institution - 0325
    • Henan
      • Zhengzhou, Henan, China
        • Local Institution - 0324
      • Zhengzhou, Henan, China, 450052
        • Local Institution - 0379
    • Hubei
      • Wuhan, Hubei, China, 430024
        • Local Institution - 0375
    • Hunan
      • Changsha, Hunan, China, 410013
        • Local Institution - 0362
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Local Institution - 0347
    • Jilin
      • Changchun, Jilin, China, 130012
        • Local Institution - 0329
      • Changchun, Jilin, China, 130021
        • Local Institution - 0361
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Local Institution - 0359
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Local Institution - 0371
    • Shan3xi
      • Xi'an, Shan3xi, China, 710038
        • Local Institution - 0333
    • Shandong
      • Qingdao, Shandong, China, 266061
        • Local Institution - 0360
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Local Institution - 0336
      • Shanghai, Shanghai Municipality, China, 200032
        • Local Institution - 0334
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Local Institution - 0376
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Local Institution - 0373
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830011
        • Local Institution - 0340
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Local Institution - 0343
      • Hangzhou, Zhejiang, China, 310009
        • Local Institution - 0370
      • Hangzhou, Zhejiang, China, 310022
        • Local Institution - 0342
  • Colombia
      • Bogotá, Colombia
        • Local Institution - 0237
      • Bogotá, Colombia
        • Local Institution - 0238
      • Medellín, Colombia, 050034
        • Local Institution - 0282
    • Risaralda Department
      • Pereira, Risaralda Department, Colombia
        • Local Institution - 0273
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Local Institution - 0112
      • Olomouc, Czechia, 779 00
        • Local Institution - 0113
      • Prague, Czechia, 140 59
        • Local Institution - 0111
      • Příbram, Czechia, 261 01
        • Local Institution - 0232
  • Finland
      • Oulu, Finland, 90029
        • Local Institution - 0270
      • Turku, Finland, 20520
        • Local Institution - 0271
  • France
      • Angers, France, 49055
        • Local Institution - 0216
      • Besançon, France
        • Local Institution - 0229
      • Caen, France, 14076
        • Local Institution - 0283
      • Créteil, France, 94010
        • Local Institution - 0218
      • Limoges, France, 87042
        • Local Institution - 0228
      • Marseille, France, 13915
        • Local Institution - 0215
      • Paris, France, 75018
        • Local Institution - 0230
      • Pessac, France, 33604
        • Local Institution - 0227
      • Rennes, France, 350330
        • Local Institution - 0223
      • Rouen, France, 76000
        • Local Institution - 0225
      • Saint-Herblain, France, 44805
        • Local Institution - 0217
      • Saint-Priest-en-Jarez, France, 42271
        • Local Institution - 0221
      • Strasbourg, France, 67000
        • Local Institution - 0224
      • Toulon, France, 83056
        • Local Institution - 0226
    • Rhône
      • Bron, Rhône, France, 69677
        • Local Institution - 0222
  • Germany
      • Bad Berka, Germany, 99437
        • Local Institution - 0213
      • Berlin, Germany, 13125
        • Local Institution - 0208
      • Essen, Germany, 45147
        • Local Institution - 0205
      • Frankfurt, Germany, 60590
        • Local Institution - 0210
      • Gera, Germany, 07548
        • Local Institution - 0211
      • Großhansdorf, Germany, 22927
        • Local Institution - 0203
      • Halle, Germany, 06120
        • Local Institution - 0209
      • Heidelberg, Germany, 69126
        • Local Institution - 0202
      • Hemer, Germany, 58675
        • Local Institution - 0214
      • Immenstadt im Allgäu, Germany, 87509
        • Local Institution - 0206
      • München, Germany, 81925
        • Local Institution - 0204
      • Stuttgart, Germany, 70376
        • Local Institution - 0201
      • Wiesbaden, Germany, 65199
        • Local Institution - 0212
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Germany, 39120
        • Local Institution - 0231
  • Greece
      • Heraklion, Greece, 711 10
        • Local Institution - 0095
      • Neo Faliro, Greece, 18547
        • Local Institution - 0190
      • Thessaloniki, Greece, 54007
        • Local Institution - 0101
    • Attikí
      • Athens, Attikí, Greece, 115 27
        • Local Institution - 0094
  • Hungary
      • Budapest, Hungary, 1083
        • Local Institution - 0025
      • Budapest, Hungary, 1121
        • Local Institution - 0024
      • Mátraháza, Hungary, 3233
        • Local Institution - 0026
  • Ireland
      • Beaumont, Ireland, Dublin 9
        • Local Institution - 0053
      • Galway, Ireland
        • Local Institution - 0055
      • Limerick, Ireland
        • Local Institution - 0100
    • Dublin
      • Dublin, Dublin, Ireland
        • Local Institution - 0054
  • Israel
      • Jerusalem, Israel, 91120
        • Local Institution - 0187
      • Kfar Saba, Israel, 44281
        • Local Institution - 0186
      • Petah Tikva, Israel, 49100
        • Local Institution - 0185
      • Tel Litwinsky, Israel, 52621
        • Local Institution - 0184
      • Ẕerifin, Israel, 70300
        • Local Institution - 0188
  • Italy
      • Avellino, Italy, 83024
        • Azienda Ospedaliera Moscati
      • Bergamo, Italy, 24127
        • Local Institution - 0179
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
      • Livorno, Italy, 57124
        • Local Institution - 0084
      • Messina, Italy, 98125
        • Policlinico G. Martino
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori Fondazione Pascale
      • Perugia, Italy, 06132
        • Local Institution - 0087
      • Ravenna, Italy, 48121
        • Ospedale Santa Maria delle Croci
      • Roma, Italy, 00161
        • Local Institution - 0089
      • Roma, Italy, 00144
        • Ifo-Istituto Regina Elena
      • Terni, Italy, 05100
        • Local Institution - 0085
    • Lombardy
      • Milan, Lombardy, Italy, 20141
        • Local Institution - 0083
  • Japan
      • Okayama, Japan, 700-8558
        • Local Institution - 0165
      • Tokyo, Japan, 113-8603
        • Local Institution - 0162
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 4600001
        • Local Institution - 0153
      • Nagoya, Aichi-ken, Japan, 4648681
        • Local Institution - 0152
    • Chiba
      • Chiba, Chiba, Japan, 260-8677
        • Local Institution - 0260
      • Kashiwa-shi, Chiba, Japan, 2778577
        • Local Institution - 0148
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • Local Institution - 0159
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 8120054
        • Local Institution - 0160
      • Kurume-shi, Fukuoka, Japan, 8300011
        • Local Institution - 0259
    • Gunma
      • Ota-shi, Gunma, Japan, 3730828
        • Local Institution - 0255
    • Hiroshima
      • Hiroshima, Hiroshima, Japan, 7308518
        • Local Institution - 0258
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0030804
        • Local Institution - 0163
      • Sapporo, Hokkaido, Japan, 0608648
        • Local Institution - 0253
    • Hyōgo
      • Akashi-shi, Hyōgo, Japan, 6738558
        • Local Institution - 0252
      • Kobe, Hyōgo, Japan, 6500047
        • Local Institution - 0156
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 9208641
        • Local Institution - 0146
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 2210855
        • Local Institution - 0161
      • Yokohama, Kanagawa, Japan, 2360051
        • Local Institution - 0150
    • Miyagi
      • Natori-shi, Miyagi, Japan, 9811293
        • Local Institution - 0275
      • Sendai, Miyagi, Japan, 9800873
        • Local Institution - 0254
      • Sendai, Miyagi, Japan, 9808574
        • Local Institution - 0145
    • Niigata
      • Niigata, Niigata, Japan, 9518566
        • Local Institution - 0164
    • Okayama-ken
      • Kurashiki-shi, Okayama-ken, Japan, 7100052
        • Local Institution - 0158
    • Osaka
      • Hirakata-shi, Osaka, Japan, 5731191
        • Local Institution - 0155
      • Osaka, Osaka, Japan, 5340021
        • Local Institution - 0154
      • Osakasayama-shi, Osaka, Japan, 5890014
        • Local Institution - 0251
      • Takatsuki-shi, Osaka, Japan, 5698686
        • Local Institution - 0257
    • Saitama
      • Hidaka-shi, Saitama, Japan, 3501298
        • Local Institution - 0353
      • Kitaadachi-gun, Saitama, Japan, 3620806
        • Local Institution - 0256
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 4118777
        • Local Institution - 0151
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 1040045
        • Local Institution - 0147
      • Koto-ku, Tokyo, Japan, 1358550
        • Local Institution - 0149
      • Shinjuku-ku, Tokyo, Japan, 1600023
        • Local Institution - 0278
    • Wakayama
      • Wakayama, Wakayama, Japan, 641-8510
        • Local Institution - 0157
    • Yamaguchi
      • Ube-shi, Yamaguchi, Japan, 7550241
        • Local Institution - 0354
  • Lebanon
      • Beirut, Lebanon, 00961
        • Local Institution - 0287
      • Beirut, Lebanon, 166830
        • Local Institution - 0286
  • Mexico
      • Chihuahua City, Mexico, 31217
        • Local Institution - 0192
      • San Luis Potosí City, Mexico, 78200
        • Local Institution - 0195
      • San Luis Potosí City, Mexico, 78213
        • Local Institution - 0236
      • Toluca, Mexico, 50180
        • Local Institution - 0194
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44270
        • Local Institution - 0197
      • Zapopan, Jalisco, Mexico, 44280
        • Local Institution - 0191
    • Mexico City
      • Df, Mexico City, Mexico, 06720
        • Local Institution - 0196
      • Mexico City, Mexico City, Mexico, 14080
        • Local Institution - 0193
    • Michoacán
      • Morelia, Michoacán, Mexico, 58000
        • Local Institution - 0267
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64060
        • Local Institution - 0277
    • State of Mexico
      • Cuautitlán, State of Mexico, Mexico, 54769
        • Local Institution - 0198
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Local Institution - 0303
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Local Institution - 0036
      • Amsterdam, Netherlands, 1081 HV
        • Local Institution - 0189
      • Breda, Netherlands, 4818 CK
        • Local Institution - 0169
      • Rotterdam, Netherlands, 3014 GD
        • Local Institution - 0037
      • Veldhoven, Netherlands, 5504 DB
        • Local Institution - 0039
  • Peru
      • Lima, Peru
        • Local Institution - 0262
      • Lima, Peru
        • Local Institution - 0263
      • Lima, Peru, 27
        • Local Institution - 0350
      • Lima, Peru, 34
        • Local Institution - 0261
      • Lima, Peru, Lima 41
        • Local Institution - 0351
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Local Institution - 0060
      • Gdansk, Poland, 80-19
        • Local Institution - 0058
      • Gdynia, Poland, 81-519
        • Local Institution - 0063
      • Gliwice, Poland, 44-101
        • Local Institution - 0072
      • Lodz, Poland, 93-513
        • Local Institution - 0057
      • Warsaw, Poland, 02-781
        • Local Institution - 0059
      • Wroclaw, Poland, 52-229
        • Local Institution - 0070
  • Romania
      • Craiova, Romania, 200542
        • Local Institution - 0167
      • Floreşti, Romania, 407280
        • Local Institution - 0250
      • Romania, Romania, 400015
        • Local Institution - 0166
      • Sector 2, Romania, 022328
        • Local Institution - 0284
  • Russia
      • Chelyabinsk, Russia, 454048
        • Local Institution - 0137
      • Kazan', Russia, 420029
        • Local Institution - 0142
      • Moscow, Russia, 115478
        • Local Institution - 0022
      • Saint Petersburg, Russia, 194291
        • Local Institution - 0028
      • Saint Petersburg, Russia, 197758
        • Local Institution - 0049
      • Saint Petersburg, Russia, 198255
        • Local Institution - 0027
      • Ufa, Russia, 450054
        • Local Institution - 0143
  • South Africa
      • Vereeniging, South Africa, 1936
        • Local Institution - 0305
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0002
        • Local Institution - 0264
      • Sandton, Gauteng, South Africa, 2196
        • Local Institution - 0234
      • Saxonwold, Johannesburg, Gauteng, South Africa, 2196
        • Local Institution - 0233
  • South Korea
      • Cheongju-si, South Korea, 28644
        • Local Institution - 0249
      • Gangnam-gu, South Korea, 06351
        • Local Institution - 0133
      • Seoul, South Korea, 05505
        • Local Institution - 0132
      • Seoul, South Korea, 06591
        • Local Institution - 0135
    • Kyǒnggi-do
      • Seongnam-si, Kyǒnggi-do, South Korea, 436-707
        • Local Institution - 0136
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0066
      • Barcelona, Spain, 08916
        • Local Institution - 0067
      • Madrid, Spain, 28041
        • Local Institution - 0065
      • Seville, Spain, 41013
        • Local Institution - 0069
      • Valencia, Spain, 46014
        • Local Institution - 0068
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Local Institution - 0064
  • Switzerland
      • Basel, Switzerland, 4031
        • Local Institution - 0243
      • Chur, Switzerland, 7000
        • Local Institution - 0246
      • Lausanne, Switzerland, 1011
        • Local Institution - 0244
      • Winterthur, Switzerland, 8401
        • Local Institution - 0245
  • Taiwan
      • Taichung, Taiwan, 407
        • Local Institution - 0139
      • Taipei, Taiwan, 100
        • Local Institution - 0138
      • Taipei, Taiwan, 112
        • Local Institution - 0140
      • Taipei, Taiwan, 235
        • Local Institution - 0310
      • Taoyuan, Taiwan, 333
        • Local Institution - 0141
  • United Kingdom
      • Birmingham, United Kingdom, B4 6DHH
        • Local Institution - 0265
      • Cambridgeshire, United Kingdom, CB2 2QQ
        • Local Institution - 0051
      • Edinburgh, United Kingdom, EH4 2XU
        • Local Institution - 0109
      • London, United Kingdom, N18 1QX
        • Local Institution - 0097
      • London, United Kingdom, SE1 9RT
        • Local Institution - 0050
      • Surrey, United Kingdom, SM2 5PT
        • Local Institution - 0119
    • Cleveland
      • Middlesbrough, Cleveland, United Kingdom, TS4 3BW
        • Local Institution - 0266
    • Greater London
      • London, Greater London, United Kingdom, SW3 6JJ
        • Local Institution - 0098
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 0YD
        • Local Institution - 0099
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
        • Local Institution - 0118
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Southern Cancer Center, Inc.
    • California
      • San Francisco, California, United States, 94115
        • Local Institution - 0017
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Local Institution - 0021
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 0001
      • Marietta, Georgia, United States, 30060
        • Local Institution - 0013
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Local Institution - 0004
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Local Institution - 0115
    • New York
      • Buffalo, New York, United States, 14263
        • Local Institution - 0005
      • New York, New York, United States, 10065
        • Local Institution - 0019
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Local Institution - 0014
      • Columbus, Ohio, United States, 43210
        • Local Institution - 0009
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Local Institution - 0007
      • Langhorne, Pennsylvania, United States, 19047
        • Local Institution - 0075
      • Philadelphia, Pennsylvania, United States, 19107
        • Local Institution - 0299
      • Philadelphia, Pennsylvania, United States, 19111-2412
        • Local Institution - 0012
      • Sayre, Pennsylvania, United States, 18840
        • Local Institution - 0015
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Local Institution - 0008
      • Greenville, South Carolina, United States, 29605
        • Local Institution - 0080
      • Greenville, South Carolina, United States, 29607
        • Local Institution - 0010
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Local Institution - 0020
    • Texas
      • Dallas, Texas, United States, 75390-8852
        • Local Institution - 0306
      • Dallas, Texas, United States, 75390
        • Local Institution - 0003
      • Houston, Texas, United States, 77030
        • Local Institution - 0102
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Local Institution - 0011
    • Washington
      • Kennewick, Washington, United States, 99336
        • Local Institution - 0074

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
  • Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
  • Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria

Exclusion Criteria:

  • Subjects with untreated Central nervous system (CNS) metastases are excluded
  • Subjects with an active, known or suspected autoimmune disease are excluded
  • Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) indicating acute or chronic infection

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Nivolumab
Nivolumab intravenously (IV) as specified
Drug: Nivolumab
Other Names:
  • Opdivo
Experimental: Arm B: Nivolumab + Ipilimumab
Nivolumab + Ipilimumab IV as specified
Drug: Ipilimumab
Other Names:
  • Yervoy
Drug: Nivolumab
Other Names:
  • Opdivo
Experimental: Arm C: Nivolumab + Platinum doublet chemotherapy
Nivolumab + Platinum doublet chemotherapy (IV) dose as specified
Drug: Gemcitabine
Drug: Cisplatin
Drug: Pemetrexed
Drug: Carboplatin
Drug: Nivolumab
Other Names:
  • Opdivo
Drug: Paclitaxel
Experimental: Arm D: Platinum doublet chemotherapy
Chemotherapy administered on specified days of IV chemotherapy
Drug: Gemcitabine
Drug: Cisplatin
Drug: Pemetrexed
Drug: Carboplatin
Drug: Paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival Per BICR
Time Frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)
Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)
Overall Survival
Time Frame: From randomization untill death or last follow up whichever occurs first (up to approximately 481 weeks)
OS for all randomized participants is the time between randomization date and the date of death from any cause.
From randomization untill death or last follow up whichever occurs first (up to approximately 481 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) Per BICR
Time Frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)

Objective response rate (ORR) is defined as the number of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)
Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale
Time Frame: Week 12
The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Disease-Related Symptom Deterioration by Week 12 defined as a 10 points or more increase from baseline in LCSS average score at any time (on or off-treatment) up to 95 days from randomization date.
Week 12

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

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.

General Publications

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)

August 5, 2015

Primary Completion (Actual)

October 25, 2024

Study Completion (Actual)

October 25, 2024

Study Registration Dates

First Submitted

June 18, 2015

First Submitted That Met QC Criteria

June 18, 2015

First Posted (Estimated)

June 23, 2015

Study Record Updates

Last Update Posted (Estimated)

October 30, 2025

Last Update Submitted That Met QC Criteria

October 21, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-227
  • 2014-003630-23 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

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