Clinical trial NCT02477826: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2015-06-23
Enrollment: 2748
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: approximately 48 months
measure: Progression-free Survival (PFS) as determined by blinded independent central review (BICR)
timeFrame: approximately 40 months
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 48 months
measure: Disease related symptom improvement as measured by the Lung Cancer Symptom Score (LCSS) in all subjects
timeFrame: Up to 48 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Southern Cancer Center, Inc.
state: Alabama
city: San Francisco
country: United States
facility: Local Institution - 0017
state: California
city: New Haven
country: United States
facility: Local Institution - 0021
state: Connecticut
city: Atlanta
country: United States
facility: Local Institution - 0001
state: Georgia
city: Marietta
country: United States
facility: Local Institution - 0013
state: Georgia
city: Lexington
country: United States
facility: Local Institution - 0004
state: Kentucky
city: Saint Louis
country: United States
facility: Local Institution - 0115
state: Missouri
city: Buffalo
country: United States
facility: Local Institution - 0005
state: New York
city: New York
country: United States
facility: Local Institution - 0019
state: New York
city: Cleveland
country: United States
facility: Local Institution - 0014
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 0009
state: Ohio
city: Allentown
country: United States
facility: Local Institution - 0007
state: Pennsylvania
city: Langhorne
country: United States
facility: Local Institution - 0075
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution - 0299
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution - 0012
state: Pennsylvania
city: Sayre
country: United States
facility: Local Institution - 0015
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution - 0008
state: South Carolina
city: Greenville
country: United States
facility: Local Institution - 0080
state: South Carolina
city: Greenville
country: United States
facility: Local Institution - 0010
state: South Carolina
city: Nashville
country: United States
facility: Local Institution - 0020
state: Tennessee
city: Dallas
country: United States
facility: Local Institution - 0306
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0003
state: Texas
city: Houston
country: United States
facility: Local Institution - 0102
state: Texas
city: Salt Lake City
country: United States
facility: Local Institution - 0011
state: Utah
city: Kennewick
country: United States
facility: Local Institution - 0074
state: Washington
city: Berazategui
country: Argentina
facility: Local Institution - 0170
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Local Institution - 0171
state: Buenos Aires
city: Ciudad Autonoma De Buenos Aire
country: Argentina
facility: Local Institution - 0172
state: Buenos Aires
city: Ciudad de Buenos Aires
country: Argentina
facility: Local Institution - 0176
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Local Institution - 0296
state: Buenos Aires
city: Viedma
country: Argentina
facility: Local Institution - 0177
state: RIO Negro
city: San Miguel de Tucuman
country: Argentina
facility: Local Institution - 0130
state: Tucuman
city: Cordoba
country: Argentina
facility: Local Institution - 0268
city: Córdoba
country: Argentina
facility: Local Institution - 0272
city: Córdoba
country: Argentina
facility: Local Institution - 0297
city: Garran
country: Australia
facility: Local Institution - 0182
state: Australian Capital Territory
city: Blacktown
country: Australia
facility: Local Institution - 0301
state: New South Wales
city: Gosford
country: Australia
facility: Local Institution - 0300
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution - 0045
state: Queensland
city: Elizabeth Vale
country: Australia
facility: Local Institution - 0046
state: South Australia
city: Clayton
country: Australia
facility: Local Institution - 0043
state: Victoria
city: Fitzroy
country: Australia
facility: Local Institution - 0042
state: Victoria
city: Perth
country: Australia
facility: Local Institution - 0180
state: Western Australia
city: Murdoch
country: Australia
facility: Local Institution - 0040
city: North Tamworth
country: Australia
facility: Local Institution - 0183
city: Graz
country: Austria
facility: Local Institution - 0241
city: Vienna
country: Austria
facility: Local Institution - 0240
city: Wels
country: Austria
facility: Local Institution - 0239
city: Roeselare
country: Belgium
facility: Local Institution - 0121
state: West-Vlaanderen
city: Edegem
country: Belgium
facility: Local Institution - 0030
city: Gent
country: Belgium
facility: Local Institution - 0031
city: Gilly
country: Belgium
facility: Local Institution - 0034
city: Hasselt
country: Belgium
facility: Local Institution - 0117
city: Sint Niklaas
country: Belgium
facility: Local Institution - 0033
city: Salvador
country: Brazil
facility: Local Institution - 0125
state: Bahia
city: Ijui
country: Brazil
facility: Local Institution - 0124
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution - 0123
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Local Institution - 0127
state: Sao Paulo
city: Rio De Janeiro
country: Brazil
facility: Local Institution - 0129
city: Sao Paulo
country: Brazil
facility: Local Institution - 0144
city: Sao Paulo
country: Brazil
facility: Local Institution - 0126
city: Sao Paulo
country: Brazil
facility: Local Institution - 0128
city: Edmonton
country: Canada
facility: Local Institution - 0103
state: Alberta
city: St. John's
country: Canada
facility: Local Institution - 0290
state: Newfoundland and Labrador
city: London
country: Canada
facility: Local Institution - 0104
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0122
state: Quebec
city: Quebec City
country: Canada
facility: Local Institution - 0106
state: Quebec
city: Rimouski
country: Canada
facility: Local Institution - 0107
state: Quebec
city: Sherbrooke
country: Canada
facility: Local Institution - 0291
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Local Institution - 0292
state: Quebec
city: Quebec
country: Canada
facility: Local Institution - 0302
city: Santiago
country: Chile
facility: Local Institution - 0173
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0131
state: Región Metropolitana De Santiago
city: Vina Del Mar
country: Chile
facility: Local Institution - 0174
state: Valparaiso
city: Hefei
country: China
facility: Local Institution - 0380
state: Anhui
city: Beijing
country: China
facility: Local Institution - 0313
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0315
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0316
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0314
state: Beijing
city: Chongqing
country: China
facility: Local Institution - 0365
state: Chongqing
city: Chongqing
country: China
facility: Local Institution - 0364
state: Chongqing
city: Chongqing
country: China
facility: Local Institution - 0378
state: Chongqing
city: Guangzhou
country: China
facility: Local Institution - 0322
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution - 0372
state: Guangdong
city: Guanzhou
country: China
facility: Local Institution - 0319
state: Guangdong
city: Haikou
country: China
facility: Local Institution - 0323
state: Hainan
city: Haerbin
country: China
facility: Local Institution - 0325
state: Heilongjiang
city: Zhengzhou
country: China
facility: Local Institution - 0324
state: Henan
city: Zhengzhou
country: China
facility: Local Institution - 0379
state: Henan
city: Wuhan
country: China
facility: Local Institution - 0375
state: Hubei
city: Changsha
country: China
facility: Local Institution - 0362
state: Hunan
city: Nanchang
country: China
facility: Local Institution - 0347
state: Jiangxi
city: Changchun
country: China
facility: Local Institution - 0329
state: Jilin
city: Changchun
country: China
facility: Local Institution - 0361
state: Jilin
city: Shenyang
country: China
facility: Local Institution - 0359
state: Liaoning
city: Xi'an
country: China
facility: Local Institution - 0371
state: Shaanxi
city: Xi'an
country: China
facility: Local Institution - 0333
state: Shan3xi
city: Qingdao
country: China
facility: Local Institution - 0360
state: Shandong
city: Shanghai
country: China
facility: Local Institution - 0334
state: Shanghai
city: Chengdu
country: China
facility: Local Institution - 0376
state: Sichuan
city: Tianjin
country: China
facility: Local Institution - 0373
state: Tianjin
city: Urumqi
country: China
facility: Local Institution - 0340
state: Xinjiang
city: Hangzhou
country: China
facility: Local Institution - 0343
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution - 0370
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution - 0342
state: Zhejiang
city: Changsha
country: China
facility: Local Institution - 0328
city: Hangzhou
country: China
facility: Local Institution - 0341
city: Kunming
country: China
facility: Local Institution - 0345
city: Shanghai
country: China
facility: Local Institution - 0336
city: Shanghai
country: China
facility: Local Institution - 0337
city: Shantou
country: China
facility: Local Institution - 0374
city: Pereira
country: Colombia
facility: Local Institution - 0273
state: Risaralda
city: Bogota
country: Colombia
facility: Local Institution - 0237
city: Bogota
country: Colombia
facility: Local Institution - 0238
city: Medellin
country: Colombia
facility: Local Institution - 0282
city: Hradec Kralove
country: Czechia
facility: Local Institution - 0112
city: Olomouc
country: Czechia
facility: Local Institution - 0113
city: Praha 4
country: Czechia
facility: Local Institution - 0111
city: Pribram
country: Czechia
facility: Local Institution - 0232
city: Oulu
country: Finland
facility: Local Institution - 0270
city: Turku
country: Finland
facility: Local Institution - 0271
city: Bron
country: France
facility: Local Institution - 0222
state: Rhône
city: ANGERS Cedex 2
country: France
facility: Local Institution - 0216
city: Besançon Cedex
country: France
facility: Local Institution - 0229
city: Caen
country: France
facility: Local Institution - 0283
city: Creteil
country: France
facility: Local Institution - 0218
city: Limoges
country: France
facility: Local Institution - 0228
city: Marseille Cedex 20
country: France
facility: Local Institution - 0215
city: Paris
country: France
facility: Local Institution - 0230
city: Pessac
country: France
facility: Local Institution - 0227
city: Rennes
country: France
facility: Local Institution - 0223
city: Rouen
country: France
facility: Local Institution - 0225
city: Saint Priest En Jarez
country: France
facility: Local Institution - 0221
city: Saint-herblain Cedex
country: France
facility: Local Institution - 0217
city: Strasbourg
country: France
facility: Local Institution - 0224
city: Toulon
country: France
facility: Local Institution - 0226
city: Magdeburg
country: Germany
facility: Local Institution - 0231
state: Sachsen-Anhalt
city: Bad Berka
country: Germany
facility: Local Institution - 0213
city: Berlin
country: Germany
facility: Local Institution - 0208
city: Essen
country: Germany
facility: Local Institution - 0205
city: Frankfurt
country: Germany
facility: Local Institution - 0210
city: Gera
country: Germany
facility: Local Institution - 0211
city: Grosshansdorf
country: Germany
facility: Local Institution - 0203
city: Halle
country: Germany
facility: Local Institution - 0209
city: Heidelberg
country: Germany
facility: Local Institution - 0202
city: Hemer
country: Germany
facility: Local Institution - 0214
city: Immenstadt
country: Germany
facility: Local Institution - 0206
city: Muenchen
country: Germany
facility: Local Institution - 0204
city: Stuttgart
country: Germany
facility: Local Institution - 0201
city: Wiesbaden
country: Germany
facility: Local Institution - 0212
city: Athens
country: Greece
facility: Local Institution - 0094
state: Attikí
city: Heraklion
country: Greece
facility: Local Institution - 0095
city: Neo Faliro
country: Greece
facility: Local Institution - 0190
city: Thessaloniki
country: Greece
facility: Local Institution - 0101
city: Budapest
country: Hungary
facility: Local Institution - 0025
city: Budapest
country: Hungary
facility: Local Institution - 0024
city: Matrahaza
country: Hungary
facility: Local Institution - 0026
city: Dublin 8
country: Ireland
facility: Local Institution - 0054
state: Dublin
city: Beaumont
country: Ireland
facility: Local Institution - 0053
city: Galway
country: Ireland
facility: Local Institution - 0055
city: Limerick
country: Ireland
facility: Local Institution - 0100
city: Jerusalem
country: Israel
facility: Local Institution - 0187
city: Kfar-saba
country: Israel
facility: Local Institution - 0186
city: Petach Tikva
country: Israel
facility: Local Institution - 0185
city: Tel-hashomer
country: Israel
facility: Local Institution - 0184
city: Zerifin
country: Israel
facility: Local Institution - 0188
city: Milan
country: Italy
facility: Local Institution - 0083
state: Lombardia
city: Avellino
country: Italy
facility: Azienda Ospedaliera Moscati
city: Bergamo
country: Italy
facility: Local Institution - 0179
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
city: Livorno
country: Italy
facility: Local Institution - 0084
city: Messina
country: Italy
facility: Policlinico G. Martino
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione Pascale
city: Perugia
country: Italy
facility: Local Institution - 0087
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci
city: Roma
country: Italy
facility: Ifo-Istituto Regina Elena
city: Roma
country: Italy
facility: Local Institution - 0089
city: Terni
country: Italy
facility: Local Institution - 0085
city: Nagoya-shi
country: Japan
facility: Local Institution - 0153
state: Aichi
city: Nagoya
country: Japan
facility: Local Institution - 0152
state: Aichi
city: Kashiwa-shi
country: Japan
facility: Local Institution - 0148
state: Chiba
city: Matsuyama
country: Japan
facility: Local Institution - 0159
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Local Institution - 0160
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Local Institution - 0259
state: Fukuoka
city: Ota-shi
country: Japan
facility: Local Institution - 0255
state: Gunma
city: Hiroshima-shi
country: Japan
facility: Local Institution - 0258
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Local Institution - 0163
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Local Institution - 0253
state: Hokkaido
city: Akashi-shi
country: Japan
facility: Local Institution - 0252
state: Hyogo
city: Kobe-shi
country: Japan
facility: Local Institution - 0156
state: Hyogo
city: Kanazawa-shi
country: Japan
facility: Local Institution - 0146
state: Ishikawa
city: Yokohama-shi
country: Japan
facility: Local Institution - 0161
state: Kanagawa
city: Yokohama-Shi
country: Japan
facility: Local Institution - 0150
state: Kanagawa
city: Natori-shi
country: Japan
facility: Local Institution - 0275
state: Miyagi
city: Sendai-shi
country: Japan
facility: Local Institution - 0254
state: Miyagi
city: Sendai-shi
country: Japan
facility: Local Institution - 0145
state: Miyagi
city: Niigata-shi
country: Japan
facility: Local Institution - 0164
state: Niigata
city: Kurashiki-shi
country: Japan
facility: Local Institution - 0158
state: Okayama
city: Hirakata-shi
country: Japan
facility: Local Institution - 0155
state: Osaka
city: Osaka-shi
country: Japan
facility: Local Institution - 0154
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Local Institution - 0251
state: Osaka
city: Takatsuki-shi
country: Japan
facility: Local Institution - 0257
state: Osaka
city: Hidaka-shi
country: Japan
facility: Local Institution - 0353
state: Saitama
city: Kitaadachi-gun
country: Japan
facility: Local Institution - 0256
state: Saitama
city: Sunto-gun
country: Japan
facility: Local Institution - 0151
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Local Institution - 0147
state: Tokyo
city: Koto-ku
country: Japan
facility: Local Institution - 0149
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Local Institution - 0278
state: Tokyo
city: Wakayama-shi
country: Japan
facility: Local Institution - 0157
state: Wakayama
city: Ube-shi
country: Japan
facility: Local Institution - 0354
state: Yamaguchi
city: Chiba
country: Japan
facility: Local Institution - 0260
city: Okayama
country: Japan
facility: Local Institution - 0165
city: Tokyo
country: Japan
facility: Local Institution - 0162
city: Seongnam-si
country: Korea, Republic of
facility: Local Institution - 0136
state: Kyǒnggi-do
city: Cheongju-si
country: Korea, Republic of
facility: Local Institution - 0249
city: Gangnam-gu
country: Korea, Republic of
facility: Local Institution - 0133
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0132
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0135
city: Beirut
country: Lebanon
facility: Local Institution - 0287
city: Beirut
country: Lebanon
facility: Local Institution - 0286
city: Df
country: Mexico
facility: Local Institution - 0196
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution - 0193
state: Distrito Federal
city: Cuautitlan
country: Mexico
facility: Local Institution - 0198
state: Estado DE Mexico
city: Guadalajara
country: Mexico
facility: Local Institution - 0197
state: Jalisco
city: Zapopan
country: Mexico
facility: Local Institution - 0191
state: Jalisco
city: Morelia
country: Mexico
facility: Local Institution - 0267
state: Michoacan
city: Monterrey
country: Mexico
facility: Local Institution - 0277
state: Nuevo Leon
city: Merida
country: Mexico
facility: Local Institution - 0303
state: Yucatán
city: Chihuahua
country: Mexico
facility: Local Institution - 0192
city: San Luis Potosi
country: Mexico
facility: Local Institution - 0195
city: San Luis Potosi
country: Mexico
facility: Local Institution - 0236
city: Toluca
country: Mexico
facility: Local Institution - 0194
city: Amsterdam
country: Netherlands
facility: Local Institution - 0036
city: Amsterdam
country: Netherlands
facility: Local Institution - 0189
city: Breda
country: Netherlands
facility: Local Institution - 0169
city: Rotterdam
country: Netherlands
facility: Local Institution - 0037
city: Veldhoven
country: Netherlands
facility: Local Institution - 0039
city: Lima
country: Peru
facility: Local Institution - 0262
city: Lima
country: Peru
facility: Local Institution - 0263
city: Lima
country: Peru
facility: Local Institution - 0350
city: Lima
country: Peru
facility: Local Institution - 0261
city: Lima
country: Peru
facility: Local Institution - 0351
city: Bydgoszcz
country: Poland
facility: Local Institution - 0060
city: Gdansk
country: Poland
facility: Local Institution - 0058
city: Gdynia
country: Poland
facility: Local Institution - 0063
city: Gliwice
country: Poland
facility: Local Institution - 0072
city: Lodz
country: Poland
facility: Local Institution - 0057
city: Warszawa
country: Poland
facility: Local Institution - 0059
city: Wroclaw
country: Poland
facility: Local Institution - 0070
city: Craiova
country: Romania
facility: Local Institution - 0167
city: Floresti
country: Romania
facility: Local Institution - 0250
city: Romania
country: Romania
facility: Local Institution - 0166
city: Sector 2
country: Romania
facility: Local Institution - 0284
city: Chelyabinsk
country: Russian Federation
facility: Local Institution - 0137
city: Kazan
country: Russian Federation
facility: Local Institution - 0142
city: Moscow
country: Russian Federation
facility: Local Institution - 0022
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution - 0049
city: St. Petersburg
country: Russian Federation
facility: Local Institution - 0028
city: St. Petersburg
country: Russian Federation
facility: Local Institution - 0027
city: Ufa
country: Russian Federation
facility: Local Institution - 0143
city: Pretoria
country: South Africa
facility: Local Institution - 0264
state: Gauteng
city: Sandton
country: South Africa
facility: Local Institution - 0234
state: Gauteng
city: Saxonwold, Johannesburg
country: South Africa
facility: Local Institution - 0233
state: Gauteng
city: Vereeniging
country: South Africa
facility: Local Institution - 0305
city: Majadahonda
country: Spain
facility: Local Institution - 0064
state: Madrid
city: Barcelona
country: Spain
facility: Local Institution - 0066
city: Barcelona
country: Spain
facility: Local Institution - 0067
city: Madrid
country: Spain
facility: Local Institution - 0065
city: Sevilla
country: Spain
facility: Local Institution - 0069
city: Valencia
country: Spain
facility: Local Institution - 0068
city: Basel
country: Switzerland
facility: Local Institution - 0243
city: Chur
country: Switzerland
facility: Local Institution - 0246
city: Lausanne
country: Switzerland
facility: Local Institution - 0244
city: Winterthur
country: Switzerland
facility: Local Institution - 0245
city: Taichung
country: Taiwan
facility: Local Institution - 0139
city: Taipei
country: Taiwan
facility: Local Institution - 0138
city: Taipei
country: Taiwan
facility: Local Institution - 0140
city: Taipei
country: Taiwan
facility: Local Institution - 0310
city: Taoyuan city
country: Taiwan
facility: Local Institution - 0141
city: Middlesborough
country: United Kingdom
facility: Local Institution - 0266
state: Cleveland
city: London
country: United Kingdom
facility: Local Institution - 0098
state: Greater London
city: Southampton
country: United Kingdom
facility: Local Institution - 0099
state: Hampshire
city: Leicester
country: United Kingdom
facility: Local Institution - 0118
state: Leicestershire
city: Birmingham
country: United Kingdom
facility: Local Institution - 0265
city: Cambridgeshire
country: United Kingdom
facility: Local Institution - 0051
city: Edinburgh
country: United Kingdom
facility: Local Institution - 0109
city: London
country: United Kingdom
facility: Local Institution - 0097
city: London
country: United Kingdom
facility: Local Institution - 0050
city: Surrey
country: United Kingdom
facility: Local Institution - 0119
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Reck M, Ciuleanu TE, Lee JS, Schenker M, Audigier-Valette C, Zurawski B, Linardou H, Otterson GA, Salman P, Nishio M, de la Mora Jimenez E, Lesniewski-Kmak K, Albert I, Ahmed S, Syrigos K, Penrod JR, Yuan Y, Blum SI, Nathan FE, Sun X, Moreno-Koehler A, Taylor F, O'Byrne KJ. First-Line Nivolumab Plus Ipilimumab Versus Chemotherapy in Advanced NSCLC With 1% or Greater Tumor PD-L1 Expression: Patient-Reported Outcomes From CheckMate 227 Part 1. J Thorac Oncol. 2021 Apr;16(4):665-676. doi: 10.1016/j.jtho.2020.12.019. Epub 2021 Jan 21.
citation: Hellmann MD, Paz-Ares L, Bernabe Caro R, Zurawski B, Kim SW, Carcereny Costa E, Park K, Alexandru A, Lupinacci L, de la Mora Jimenez E, Sakai H, Albert I, Vergnenegre A, Peters S, Syrigos K, Barlesi F, Reck M, Borghaei H, Brahmer JR, O'Byrne KJ, Geese WJ, Bhagavatheeswaran P, Rabindran SK, Kasinathan RS, Nathan FE, Ramalingam SS. Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2019 Nov 21;381(21):2020-2031. doi: 10.1056/NEJMoa1910231. Epub 2019 Sep 28.
citation: Reck M, Schenker M, Lee KH, Provencio M, Nishio M, Lesniewski-Kmak K, Sangha R, Ahmed S, Raimbourg J, Feeney K, Corre R, Franke FA, Richardet E, Penrod JR, Yuan Y, Nathan FE, Bhagavatheeswaran P, DeRosa M, Taylor F, Lawrance R, Brahmer J. Nivolumab plus ipilimumab versus chemotherapy as first-line treatment in advanced non-small-cell lung cancer with high tumour mutational burden: patient-reported outcomes results from the randomised, open-label, phase III CheckMate 227 trial. Eur J Cancer. 2019 Jul;116:137-147. doi: 10.1016/j.ejca.2019.05.008. Epub 2019 Jun 11.
citation: Hellmann MD, Ciuleanu TE, Pluzanski A, Lee JS, Otterson GA, Audigier-Valette C, Minenza E, Linardou H, Burgers S, Salman P, Borghaei H, Ramalingam SS, Brahmer J, Reck M, O'Byrne KJ, Geese WJ, Green G, Chang H, Szustakowski J, Bhagavatheeswaran P, Healey D, Fu Y, Nathan F, Paz-Ares L. Nivolumab plus Ipilimumab in Lung Cancer with a High Tumor Mutational Burden. N Engl J Med. 2018 May 31;378(22):2093-2104. doi: 10.1056/NEJMoa1801946. Epub 2018 Apr 16.