Lung Cancer Clinical Trial
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)
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
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There are 267 Locations for this study
Mobile Alabama, 36608, United States
San Francisco California, 94115, United States
New Haven Connecticut, 06520, United States
Atlanta Georgia, 30322, United States
Marietta Georgia, 30060, United States
Lexington Kentucky, 40503, United States
Saint Louis Missouri, 63110, United States
Buffalo New York, 14263, United States
New York New York, 10065, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43210, United States
Allentown Pennsylvania, 18103, United States
Langhorne Pennsylvania, 19047, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Sayre Pennsylvania, 18840, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29607, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75390, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84108, United States
Kennewick Washington, 99336, United States
Berazategui Buenos Aires, 1880, Argentina
Capital Federal Buenos Aires, 1426, Argentina
Ciudad Autonoma De Buenos Aire Buenos Aires, 1181, Argentina
Ciudad de Buenos Aires Buenos Aires, 1025, Argentina
Mar Del Plata Buenos Aires, 7600, Argentina
Viedma RIO Negro, 8500, Argentina
San Miguel de Tucuman Tucuman, 4000, Argentina
Cordoba , 5000, Argentina
Cordoba , X5004, Argentina
Córdoba , 5016, Argentina
Garran Australian Capital Territory, 2605, Australia
Blacktown New South Wales, 2148, Australia
Gosford New South Wales, 2250, Australia
Tamworth New South Wales, 2340, Australia
Brisbane Queensland, 4102, Australia
Elizabeth Vale South Australia, 5112, Australia
Clayton Victoria, 3168, Australia
Fitzroy Victoria, 3065, Australia
Perth Western Australia, 6150, Australia
Murdoch , 6150, Australia
Graz , 8036, Austria
Vienna , 1090, Austria
Wels , 4600, Austria
Edegem , 2650, Belgium
Gent , 9000, Belgium
Gilly , 6060, Belgium
Hasselt , 3500, Belgium
Roeselare , 8800, Belgium
Sint Niklaas , 9100, Belgium
Salvador Bahia, 40170, Brazil
Ijui RIO Grande DO SUL, 98700, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Barretos Sao Paulo, 14784, Brazil
Rio De Janeiro , 20231, Brazil
Sao Paulo , 01321, Brazil
Sao Paulo , 01509, Brazil
Sao Paulo , 05403, Brazil
Edmonton Alberta, T6G 1, Canada
St. John's Newfoundland and Labrador, A1B 3, Canada
London Ontario, N6A 4, Canada
Montreal Quebec, H3T 1, Canada
Quebec City Quebec, G1J 1, Canada
Rimouski Quebec, G5L 5, Canada
Sherbrooke Quebec, J1H 5, Canada
Trois-Rivieres Quebec, G8Z 3, Canada
Quebec , G1V 4, Canada
Santiago Metropolitana, 75009, Chile
Santiago Metropolitana, 84203, Chile
Vina Del Mar Valparaiso, 254 0, Chile
Hefei Anhui, 23000, China
Beijing Beijing, 10000, China
Beijing Beijing, 10002, China
Beijing Beijing, 10002, China
Beijing Beijing, 10003, China
Chongqing Chongqing, 40003, China
Chongqing Chongqing, 40004, China
Guangzhou Guangdong, 51006, China
Guangzhou Guangdong, 51009, China
Guanzhou Guangdong, 51008, China
Haerbin Heilongjiang, 15008, China
Zhengzhou Henan, 0, China
Zhengzhou Henan, 45005, China
Wuhan Hubei, 43002, China
Changsha Hunan, 41001, China
Nanchang Jiangxi, 0, China
Changchun Jilin, 13001, China
Changchun Jilin, 13002, China
Shenyang Liaoning, 11000, China
Xi'an Shaanxi, 71006, China
Xi'an Shan3xi, 71003, China
Qingdao Shandong, 26606, China
Shanghai Shanghai, 20003, China
Chengdu Sichuan, 61004, China
Tianjin Tianjin, 30006, China
Urumqi Xinjiang, 83001, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31002, China
Changsha , 0, China
Chongqing , 40003, China
Haikou , 57031, China
Hangzhou , 31001, China
Kunming , 0, China
Shanghai , 20003, China
Shanghai , 20003, China
Shantou , 0, China
Pereira Risaralda, 0, Colombia
Bogota , 0, Colombia
Bogota , 0, Colombia
Medellin , 05003, Colombia
Hradec Kralove , 500 0, Czechia
Olomouc , 779 0, Czechia
Praha 4 , 140 5, Czechia
Pribram , 261 0, Czechia
Oulu , 90029, Finland
Turku , 20520, Finland
Bron Rhône, 69677, France
ANGERS Cedex 2 , 49055, France
Besançon Cedex , 0, France
Caen , 14076, France
Creteil , 94010, France
Limoges , 87042, France
Marseille Cedex 20 , 13915, France
Paris , 75018, France
Pessac , 33604, France
Rennes , 35033, France
Rouen Cedex , 76038, France
Saint Priest En Jarez , 42271, France
Saint-herblain Cedex , 44805, France
Strasbourg , 67000, France
Toulon , 83056, France
Magdeburg Sachsen-Anhalt, 39120, Germany
Bad Berka , 99437, Germany
Berlin , 13125, Germany
Essen , 45147, Germany
Frankfurt , 60590, Germany
Gera , 07548, Germany
Grosshansdorf , 22927, Germany
Halle , 06120, Germany
Heidelberg , 69126, Germany
Hemer , 58675, Germany
Immenstadt , 87509, Germany
Muenchen , 81925, Germany
Stuttgart , 70376, Germany
Wiesbaden , 65199, Germany
Athens AttikÃ, 115 2, Greece
Heraklion , 711 1, Greece
Neo Faliro , 18547, Greece
Thessaloniki , 54007, Greece
Budapest , 1083, Hungary
Budapest , 1121, Hungary
Matrahaza , 3233, Hungary
Dublin 8 Dublin, , Ireland
Dublin , 9, Ireland
Galway , 0, Ireland
Limerick , 0, Ireland
Jerusalem , 91120, Israel
Kfar-saba , 44281, Israel
Petach Tikva , 49100, Israel
Tel-hashomer , 52621, Israel
Zerifin , 70300, Israel
Milan Lombardia, 20141, Italy
Avellino , 83024, Italy
Bergamo , 24127, Italy
Bologna , 40138, Italy
Livorno , 57124, Italy
Messina , 98125, Italy
Milan , 20133, Italy
Napoli , 80131, Italy
Perugia , 06132, Italy
Ravenna , 48121, Italy
Roma , 00144, Italy
Roma , 00161, Italy
Terni , 05100, Italy
Nagoya-shi Aichi, 46000, Japan
Nagoya Aichi, 46486, Japan
Chiba-shi Chiba, 26008, Japan
Kashiwa-shi Chiba, 27785, Japan
Matsuyama Ehime, 791-0, Japan
Fukuoka-shi Fukuoka, 81200, Japan
Kurume-shi Fukuoka, 83000, Japan
Ota Gunma, 373-8, Japan
Hiroshima-shi Hiroshima, 73085, Japan
Sapporo-shi Hokkaido, 00308, Japan
Sapporo-shi Hokkaido, 06086, Japan
Akashi-shi Hyogo, 67385, Japan
Kobe-shi Hyogo, 65000, Japan
Kanazawa-shi Ishikawa, 92086, Japan
Yokohama-shi Kanagawa, 22108, Japan
Yokohama-Shi Kanagawa, 23600, Japan
Natori-shi Miyagi, 98112, Japan
Sendai-shi Miyagi, 98008, Japan
Sendai-shi Miyagi, 98085, Japan
Niigata-shi Niigata, 95185, Japan
Kurashiki-shi Okayama, 71000, Japan
Okayama-shi Okayama, 70009, Japan
Hirakata-shi Osaka, 57311, Japan
Osaka-shi Osaka, 53400, Japan
Osakasayama-shi Osaka, 58900, Japan
Takatsuki-shi Osaka, 56986, Japan
Hidaka-shi Saitama, 35012, Japan
Kitaadachi-gun Saitama, 36208, Japan
Sunto-gun Shizuoka, 41187, Japan
Chuo-ku Tokyo, 10400, Japan
Koto-ku Tokyo, 13585, Japan
Shinjuku-ku Tokyo, 16000, Japan
Wakayama-shi Wakayama, 641-8, Japan
Ube-shi Yamaguchi, 75502, Japan
Tokyo , 113-8, Japan
Seongnam-si KyÇ’nggi-do, 436-7, Korea, Republic of
Cheongju-si , 28644, Korea, Republic of
Gangnam-gu , 06351, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06591, Korea, Republic of
Beirut , 00961, Lebanon
Beirut , 16683, Lebanon
Df Distrito Federal, 06720, Mexico
Mexico Distrito Federal, 14080, Mexico
Cuautitlan Estado DE Mexico, 54769, Mexico
Zapopan Jalisco, 44280, Mexico
Morelia Michoacan, 58000, Mexico
Monterrey Nuevo Leon, 64060, Mexico
Merida Yucatan, 97070, Mexico
Chihuahua , 31217, Mexico
San Luis Potosi , 78200, Mexico
San Luis Potosi , 78213, Mexico
Toluca , 50180, Mexico
Amsterdam , 1066 , Netherlands
Amsterdam , 1081 , Netherlands
Breda , 4818 , Netherlands
Rotterdam , 3014 , Netherlands
Veldhoven , 5504 , Netherlands
Lima , 0, Peru
Lima , 0, Peru
Lima , 27, Peru
Lima , 34, Peru
Lima , Lima , Peru
Bydgoszcz , 85-79, Poland
Gdansk , 80-19, Poland
Gdynia , 81-51, Poland
Gliwice , 44-10, Poland
Lodz , 93-51, Poland
Warszawa , 02-78, Poland
Wroclaw , 52-22, Poland
Craiova , 20054, Romania
Floresti , 40728, Romania
Romania , 40001, Romania
Sector 2 , 02232, Romania
Chelyabinsk , 45404, Russian Federation
Kazan , 42002, Russian Federation
Moscow , 11547, Russian Federation
Saint-Petersburg , 19775, Russian Federation
St. Petersburg , 19429, Russian Federation
St. Petersburg , 19825, Russian Federation
Ufa , 45005, Russian Federation
Pretoria Gauteng, 0002, South Africa
Sandton Gauteng, 2196, South Africa
Saxonwold, Johannesburg Gauteng, 2196, South Africa
Vereeniging , 1936, South Africa
Majadahonda Madrid, 28222, Spain
Barcelona , 08035, Spain
Barcelona , 08916, Spain
Madrid , 28041, Spain
Sevilla , 41013, Spain
Valencia , 46014, Spain
Basel , 4031, Switzerland
Chur , 7000, Switzerland
Lausanne , 1011, Switzerland
Winterthur , 8401, Switzerland
Taichung , 407, Taiwan
Taipei , 100, Taiwan
Taipei , 112, Taiwan
Taipei , 235, Taiwan
Taoyuan city , 333, Taiwan
Middlesborough Cleveland, TS4 3, United Kingdom
London Greater London, SW3 6, United Kingdom
Southampton Hampshire, SO16 , United Kingdom
Leicester Leicestershire, LE1 5, United Kingdom
Birmingham , B4 6D, United Kingdom
Cambridgeshire , CB2 2, United Kingdom
Edinburgh , EH4 2, United Kingdom
London , N18 1, United Kingdom
London , SE1 9, United Kingdom
Surrey , SM2 5, United Kingdom
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