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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02477826
Recruitment Status : Recruiting
First Posted : June 23, 2015
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Nivolumab Drug: Ipilimumab Drug: Carboplatin Drug: Cisplatin Drug: Gemcitabine Drug: Pemetrexed Drug: Paclitaxel Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 5, 2015
Estimated Primary Completion Date : November 8, 2020
Estimated Study Completion Date : August 23, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Arm A: Nivolumab
Nivolumab intravenously (IV) as specified
Drug: Nivolumab
Other Name: Opdivo

Experimental: Arm B: Nivolumab + Ipilimumab
Nivolumab + Ipilimumab IV as specified
Drug: Nivolumab
Other Name: Opdivo

Drug: Ipilimumab
Other Name: Yervoy

Experimental: Arm C: Nivolumab + Platinum doublet chemotherapy
Nivolumab + Platinum doublet chemotherapy (IV) dose as specified
Drug: Nivolumab
Other Name: Opdivo

Drug: Carboplatin
Drug: Cisplatin
Drug: Gemcitabine
Drug: Pemetrexed
Drug: Paclitaxel
Experimental: Arm D: Platinum doublet chemotherapy
Chemotherapy administered on specified days of IV chemotherapy
Drug: Carboplatin
Drug: Cisplatin
Drug: Gemcitabine
Drug: Pemetrexed
Drug: Paclitaxel



Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: approximately 48 months ]
  2. Progression-free Survival (PFS) as determined by blinded independent central review (BICR) [ Time Frame: approximately 40 months ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Up to 48 months ]
    ORR of nivolumab monotherapy and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy in subjects with advanced lung cancer

  2. Disease related symptom improvement as measured by the Lung Cancer Symptom Score (LCSS) in all subjects [ Time Frame: Up to 48 months ]
    Disease related symptom improvement assessed at each dosing for 6 months, then every 6 weeks while on treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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 could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477826


Contacts
Layout table for location contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

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Locations
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United States, Alabama
Southern Cancer Center, Inc. Completed
Mobile, Alabama, United States, 36608
United States, California
Local Institution Withdrawn
La Jolla, California, United States, 92093
California Pacific Medical Center Active, not recruiting
San Francisco, California, United States, 94115
United States, Connecticut
Yale University Active, not recruiting
New Haven, Connecticut, United States, 06520
United States, Georgia
Emory University Hospital Active, not recruiting
Atlanta, Georgia, United States, 30322
Northwest Georgia Oncology Centers, P.C. Active, not recruiting
Marietta, Georgia, United States, 30060
United States, Kentucky
Baptist Health Lexington Active, not recruiting
Lexington, Kentucky, United States, 40503
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins Withdrawn
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Local Institution Withdrawn
Boston, Massachusetts, United States, 02114
Local Institution Withdrawn
Boston, Massachusetts, United States, 02215
United States, Michigan
Local Institution Withdrawn
Southfield, Michigan, United States, 48075
United States, Minnesota
Local Institution Withdrawn
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School Of Medicine Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Roswell Park Cancer Institute Active, not recruiting
Buffalo, New York, United States, 14263
Memorial Sloan Kettering Cancer Center Active, not recruiting
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center Withdrawn
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospitals Active, not recruiting
Cleveland, Ohio, United States, 44106
The Ohio State University Active, not recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Lehigh Valley Health Network Active, not recruiting
Allentown, Pennsylvania, United States, 18103
St. Mary Medical Center Active, not recruiting
Langhorne, Pennsylvania, United States, 19047
Thomas Jefferson University Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center Active, not recruiting
Philadelphia, Pennsylvania, United States, 19111-2412
Guthrie Medical Group, Pc Active, not recruiting
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Hollings Cancer Center Active, not recruiting
Charleston, South Carolina, United States, 29425
Greenville Health System Active, not recruiting
Greenville, South Carolina, United States, 29605
St Francis Hospital Active, not recruiting
Greenville, South Carolina, United States, 29607
United States, Tennessee
Vanderbilt University Medical Center Active, not recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
The University Of Texas Active, not recruiting
Dallas, Texas, United States, 75390-8852
University Of Texas Southwestern Medical Center Active, not recruiting
Dallas, Texas, United States, 75390
University Of Texas Md Anderson Cancer Ctr Active, not recruiting
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute At The Univ. Of Utah Active, not recruiting
Salt Lake City, Utah, United States, 84112
United States, Washington
Kadlec Clinical Hematology and Oncology Active, not recruiting
Kennewick, Washington, United States, 99336
Argentina
COIBA Completed
Berazategui, Buenos Aires, Argentina, 1880
Instituto Alexander Fleming Active, not recruiting
Capital Federal, Buenos Aires, Argentina, 1426
Hospital Italiano De Buenos Aires Active, not recruiting
Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, 1181
Fundacion Investigar Completed
Ciudad de Buenos Aires, Buenos Aires, Argentina, 1025
Hospital Privado De Comunidad Completed
Mar Del Plata, Buenos Aires, Argentina, 7600
Hospital Privado Centro Medico De Cordoba Active, not recruiting
Córdoba, Cordoba, Argentina, 5016
Clinica Viedma S.A. Active, not recruiting
Viedma, RIO Negro, Argentina, 8500
Centro Medico San Roque Active, not recruiting
San Miguel de Tucuman, Tucuman, Argentina, 4000
Local Institution Not yet recruiting
Caba, Argentina, 1118
Contact: Site 0352         
Instituto Oncologico De Cordoba Active, not recruiting
Cordoba, Argentina, 5000
Clinica Privada Universitaria Reina Fabiola Active, not recruiting
Cordoba, Argentina, X5004FHP
Australia, Australian Capital Territory
Local Institution Active, not recruiting
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Blacktown Hospital Active, not recruiting
Blacktown, New South Wales, Australia, 2148
Local Institution Active, not recruiting
Gosford, New South Wales, Australia, 2250
Tamworth Hospital Active, not recruiting
Tamworth, New South Wales, Australia, 2340
Australia, Queensland
Princess Alexandra Hospital Active, not recruiting
Brisbane, Queensland, Australia, 4102
Australia, South Australia
Local Institution Active, not recruiting
Elizabeth Vale, South Australia, Australia, 5112
Australia, Victoria
Local Institution Active, not recruiting
Clayton, Victoria, Australia, 3168
St Vincent's Hospital Active, not recruiting
Fitzroy, Victoria, Australia, 3065
Australia, Western Australia
Local Institution Active, not recruiting
Perth, Western Australia, Australia, 6150
Australia
Local Institution Active, not recruiting
Murdoch, Australia, 6150
Austria
Medizinische Universitatsklinik Active, not recruiting
Graz, Austria, 8036
Akh Wien Active, not recruiting
Vienna, Austria, 1090
Klinikum Wels-Grieskirchen Gmbh Active, not recruiting
Wels, Austria, 4600
Belgium
Local Institution Active, not recruiting
Charleroi, Belgium, 6000
Local Institution Completed
Edegem, Belgium, 2650
Local Institution Active, not recruiting
Gent, Belgium, 9000
Local Institution Active, not recruiting
Hasselt, Belgium, 3500
Local Institution Active, not recruiting
Roeselare, Belgium, 8800
Local Institution Active, not recruiting
Sint Niklaas, Belgium, 9100
Brazil
Local Institution Completed
Salvador, Bahia, Brazil, 40170-110
Local Institution Active, not recruiting
Ijui, RIO Grande DO SUL, Brazil, 98700-000
Local Institution Active, not recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
Local Institution Active, not recruiting
Barretos, SAO Paulo, Brazil, 14784-400
Local Institution Active, not recruiting
Rio De Janeiro, Brazil, 20231-050
Local Institution Active, not recruiting
Sao Paulo, Brazil, 01321-001
Local Institution Active, not recruiting
Sao Paulo, Brazil, 01508-010
Local Institution Active, not recruiting
Sao Paulo, Brazil, 05403-010
Canada, Alberta
Cross Cancer Institute Active, not recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Newfoundland and Labrador
Dr. H.Bliss Murphy Cancer Centre Active, not recruiting
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
London Regional Cancer Program Active, not recruiting
London, Ontario, Canada, N6A 4L6
Canada, Quebec
Jewish General Hospital Active, not recruiting
Montreal, Quebec, Canada, H3T 1E2
CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski Active, not recruiting
Rimouski, Quebec, Canada, G5L 5T1
Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS Active, not recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec Active, not recruiting
Trois-Rivieres, Quebec, Canada, G8Z 3R9
Canada
CHU de Quebec - Universite Laval Active, not recruiting
Quebec, Canada, G1R 2J6
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Universite Laval Active, not recruiting
Quebec, Canada, G1V 4G5
Chile
Fundacion Arturo Lopez Perez Active, not recruiting
Santiago, Metropolitana, Chile
Centro Internacional de Estudios Clinicos Active, not recruiting
Recoleta, Santiago DE Chile, Chile
Instituto Oncologico Active, not recruiting
Vina Del Mar, Valparaiso, Chile, 254 0364
China, Beijing
Local Institution Recruiting
Beijing, Beijing, China, 100001
Contact: Site 0313         
Local Institution Withdrawn
Beijing, Beijing, China, 100021
Local Institution Recruiting
Beijing, Beijing, China, 100032
Contact: Site 0314         
China, Chongqing
Local Institution Withdrawn
Chongqing, Chongqing, China, 400038
China, Guangdong
Local Institution Completed
Guangzhou, Guangdong, China, 510060
Local Institution Recruiting
Guangzhou, Guangdong, China, 510095
Contact: Site 0372         
Local Institution Recruiting
Guanzhou, Guangdong, China, 510080
Contact: Site 0319         
China, Hainan
Local Institution Recruiting
Haikou, Hainan, China, 570311
Contact: Site 0323         
China, Heilongjiang
Local Institution Recruiting
Haerbin, Heilongjiang, China, 150081
Contact: Site 0325         
China, Henan
Local Institution Recruiting
Zhengzhou, Henan, China
Contact: Site 0324         
China, Hunan
Local Institution Recruiting
Changsha, Hunan, China, 410013
Contact: Site 0362         
China, Jiangsu
Local Institution Withdrawn
Nanjing, Jiangsu, China, 210000
China, Jiangxi
Local Institution Recruiting
Nanchang, Jiangxi, China
Contact: Site 0347         
China, Jilin
Local Institution Recruiting
Changchun, Jilin, China, 130012
Contact: Site 0329         
Local Institution Withdrawn
Changchun, Jilin, China, 130021
China, Liaoning
Local Institution Recruiting
Shenyang, Liaoning, China
Contact: Site 0359         
China, Shaanxi
Local Institution Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Site 0371         
China, Shan3xi
Local Institution Recruiting
Xi'an, Shan3xi, China, 710038
Contact: Site 0333         
China, Shandong
Local Institution Withdrawn
Qingdao, Shandong, China, 266061
China, Shanghai
Local Institution Withdrawn
Shanghai, Shanghai, China, 200025
Local Institution Recruiting
Shanghai, Shanghai, China, 200030
Contact: Site 0336         
Local Institution Recruiting
Shanghai, Shanghai, China, 200032
Contact: Site 0334         
China, Xinjiang
Local Institution Recruiting
Urumqi, Xinjiang, China, 830011
Contact: Site 0340         
China, Zhejiang
Local Institution Withdrawn
Hanghzou, Zhejiang, China
Local Institution Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Site 0343         
Local Institution Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Site 0342         
China
Local Institution Withdrawn
Beijing, China, 100021
Local Institution Withdrawn
Beijing, China, 101149
Local Institution Recruiting
Changsha, China
Contact: Site 0328         
Local Institution Recruiting
Chongqing, China, 400038
Contact: Site 0364         
Local Institution Not yet recruiting
Chongqing, China, 400042
Contact: Site 0346         
Local Institution Recruiting
Hangzhou, China, 310009
Contact: Site 0370         
Local Institution Recruiting
Hangzhou, China, 310016
Contact: Site 0341         
Local Institution Active, not recruiting
Kunming, China
Local Institution Recruiting
Shanghai, China, 200030
Contact: Site 0337         
Colombia
Oncologos Del Occidente Sa Active, not recruiting
Pereira, Risaralda, Colombia
Administradora Del Country S.A. - Clinica Del Country Active, not recruiting
Bogota, Colombia
Hospital Universitario San Ignacio Active, not recruiting
Bogota, Colombia
Hospital Pablo Tobon Uribe Active, not recruiting
Medellin, Colombia, MEDELLIN
Czechia
Plicni klinika Active, not recruiting
Hradec Kralove, Czechia, 500 05
Klinika plicnich nemoci a tuberkulozy Active, not recruiting
Olomouc, Czechia, 779 00
Pneumologicka klinika 1. LF a TN Active, not recruiting
Praha 4, Czechia, 140 59
Oddeleni Onkologie Active, not recruiting
Pribram, Czechia, 261 01
Finland
Local Institution Active, not recruiting
Oulu, Finland, 90029
Local Institution Active, not recruiting
Turku, Finland, 20520
France
Local Institution Completed
ANGERS Cedex 2, France, 49055
Local Institution Active, not recruiting
Besançon Cedex, France
Local Institution Active, not recruiting
Bron Cedex, France, 69677
Local Institution Active, not recruiting
Caen, France, 14076
Local Institution Active, not recruiting
Creteil, France, 94010
Local Institution Active, not recruiting
Limoges cedex, France, 87042
Local Institution Active, not recruiting
Marseille Cedex 20, France, 13915
Local Institution Active, not recruiting
Paris, France, 75018
Local Institution Active, not recruiting
Pessac, France, 33604
Local Institution Active, not recruiting
Rennes Cedex 9, France, 35033
Local Institution Active, not recruiting
Rouen, France, 76000
Local Institution Active, not recruiting
Saint Herblain, France, 44805
Local Institution Active, not recruiting
Saint Priest En Jarez, France, 42271
Local Institution Active, not recruiting
Strasbourg, France, 67000
Local Institution Active, not recruiting
Toulon, France, 83056
Germany
Zentralklinik Bad Berka Gmbh Active, not recruiting
Bad Berka, Thuringen, Germany, 99437
Local Institution Active, not recruiting
Berlin, Germany, 13125
Universitaetsklinikum Essen Completed
Essen, Germany, 45147
Universitatsklinikum Frankfurt Completed
Frankfurt, Germany, 60596
SRH WALD KLINIKUM GERA gGmbH Active, not recruiting
Gera, Germany, 07548
Klinik Schillerhoehe Active, not recruiting
Gerlingen, Germany, 70839
Krankenhaus Grosshansdorf Active, not recruiting
Grosshansdorf, Germany, 22927
Stadtisches Krankenhaus Martha Maria Halle-Dolau Completed
Halle, Germany, 06120
Thoraxklinik-Heidelberg Ggmbh Completed
Heidelberg, Germany, 69126
Lungenklinik Hemer Active, not recruiting
Hemer, Germany, 58675
Klinikverbund Kempten-Oberallgau Active, not recruiting
Immenstadt, Germany, 87509
Universitaetsklinikum Magdeburg A. o. R. Active, not recruiting
Magdeburg, Germany, 39120
Klinikum Bogenhausen Active, not recruiting
Muenchen, Germany, 81925
Hsk Dr.-Horst-Schmidt-Kliniken Wiesbaden Active, not recruiting
Wiesbaden, Germany, 65199
Greece
Local Institution Active, not recruiting
Athens, Greece, 11527
Local Institution Active, not recruiting
Heraklio, Greece, 71110
Local Institution Active, not recruiting
Neo Faliro, Greece, 18547
Local Institution Completed
Thessaloniki, Greece, 54007
Hungary
Local Institution Completed
Budapest, Hungary, 1121
Local Institution Active, not recruiting
Budapest, Hungary, 1125
Local Institution Active, not recruiting
Matrahaza, Hungary, 3233
Ireland
Local Institution Active, not recruiting
Dublin 8, Dublin, Ireland
Local Institution Active, not recruiting
Dublin, Ireland, 9
Local Institution Active, not recruiting
Galway, Ireland
Local Institution Active, not recruiting
Limerick, Ireland
Israel
Local Institution Completed
Jerusalem, Israel, 91120
Local Institution Active, not recruiting
Kfar-saba, Israel, 44281
Local Institution Active, not recruiting
Petach Tikva, Israel, 49100
Local Institution Active, not recruiting
Tel-hashomer, Israel, 52621
Local Institution Active, not recruiting
Zerifin, Israel, 70300
Italy
Local Institution Active, not recruiting
Avellino, Italy, 83100
Local Institution Active, not recruiting
Bergamo, Italy, 24127
Local Institution Active, not recruiting
Bologna, Italy, 40138
Local Institution Active, not recruiting
Livorno, Italy, 57124
Local Institution Active, not recruiting
Messina, Italy, 98125
Local Institution Completed
Milano, Italy, 20133
Local Institution Completed
Milan, Italy, 20141
Local Institution Active, not recruiting
Napoli, Italy, 80131
Local Institution Active, not recruiting
Ravenna, Italy, 48100
Local Institution Active, not recruiting
Roma, Italy, 00144
Local Institution Active, not recruiting
Roma, Italy, 00161
Local Institution Active, not recruiting
S.Andrea Fratte PG, Italy, 06132
Local Institution Active, not recruiting
Terni, Italy, 05100
Japan
Local Institution Active, not recruiting
Nagoya-shi, Aichi, Japan, 4600001
Local Institution Active, not recruiting
Nagoya-shi, Aichi, Japan, 4640021
Local Institution Active, not recruiting
Chiba-shi, Chiba, Japan, 2600856
Local Institution Active, not recruiting
Kashiwa-shi, Chiba, Japan, 2778577
Local Institution Active, not recruiting
Matsuyama-shi, Ehime, Japan, 7910280
Local Institution Active, not recruiting
Fukuoka-shi, Fukuoka, Japan, 8120054
Local Institution Active, not recruiting
Kurume-shi, Fukuoka, Japan, 8300011
Local Institution Active, not recruiting
Ota-shi, Gunma, Japan, 3730828
Local Institution Active, not recruiting
Hiroshima-shi, Hiroshima, Japan, 7308518
Local Institution Active, not recruiting
Sapporo-shi, Hokkaido, Japan, 0030804
Local Institution Active, not recruiting
Sapporo-shi, Hokkaido, Japan, 0608648
Local Institution Active, not recruiting
Akashi-shi, Hyogo, Japan, 6738558
Local Institution Active, not recruiting
Kobe-shi, Hyogo, Japan, 6500047
Local Institution Active, not recruiting
Kanazawa-shi, Ishikawa, Japan, 9200934
Local Institution Active, not recruiting
Yokohama-Shi, Kanagawa, Japan, 2360051
Local Institution Active, not recruiting
Yokohama-shi, Kanagawa, Japan, 2408555
Local Institution Active, not recruiting
Natori-shi, Miyagi, Japan, 9811293
Local Institution Active, not recruiting
Sendai-shi, Miyagi, Japan, 9800873
Local Institution Active, not recruiting
Sendai-shi, Miyagi, Japan, 9808574
Local Institution Active, not recruiting
Niigata-shi, Niigata, Japan, 9518133
Local Institution Active, not recruiting
Kurashiki-shi, Okayama, Japan, 7100052
Local Institution Active, not recruiting
Okayama-shi, Okayama, Japan, 7000914
Local Institution Active, not recruiting
Hirakata-shi, Osaka, Japan, 5731191
Local Institution Active, not recruiting
Osaka-shi, Osaka, Japan, 5340021
Local Institution Active, not recruiting
Osakasayama-shi, Osaka, Japan, 5890014
Local Institution Active, not recruiting
Takatsuki-shi, Osaka, Japan, 5698686
Local Institution Active, not recruiting
Hidaka-shi, Saitama, Japan, 3501298
Local Institution Active, not recruiting
Kitaadachi-gun, Saitama, Japan, 3620806
Local Institution Active, not recruiting
Sunto-gun, Shizuoka, Japan, 4118777
Local Institution Active, not recruiting
Bunkyo-ku, Tokyo, Japan, 1130022
Local Institution Active, not recruiting
Chuo-ku, Tokyo, Japan, 1040045
Local Institution Active, not recruiting
Koto-ku, Tokyo, Japan, 1358550
Local Institution Active, not recruiting
Shinjuku-ku, Tokyo, Japan, 1600023
Local Institution Active, not recruiting
Wakayama-shi, Wakayama, Japan, 6418510
Local Institution Active, not recruiting
Ube-shi, Yamaguchi, Japan, 7550241
Korea, Republic of
Local Institution Active, not recruiting
Cheongju-si, Chungcheonbuk-do, Korea, Republic of, 28644
Local Institution Active, not recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Local Institution Active, not recruiting
Seoul, Korea, Republic of, 05505
Local Institution Active, not recruiting
Seoul, Korea, Republic of, 06351
Local Institution Active, not recruiting
Seoul, Korea, Republic of, 06591
Lebanon
Local Institution Completed
Beirut, Lebanon, 166830
Local Institution Completed
Beirut, Lebanon
Mexico
Local Institution Active, not recruiting
Df, Distrito Federal, Mexico, 06720
Local Institution Active, not recruiting
Mexico, Distrito Federal, Mexico, 14080
Phylasis Clinicas Research S de R. L. de C. V. Active, not recruiting
Cuautitlan, Estado DE Mexico, Mexico, 54769
Local Institution Active, not recruiting
Toluca, Estado DE Mexico, Mexico, 50180
Instituto Jalisciense De Cancerologia Active, not recruiting
Guadalajara, Jalisco, Mexico, 44280
Local Institution Completed
Morelia, Michoacan, Mexico, 58000
Axis Heilsa S de Rl de Cv Active, not recruiting
Monterrey, Nuevo LEON, Mexico, 64060
Medical Care & Research Active, not recruiting
Merida, Yucatan, Mexico, 97070
Local Institution Completed
Chihuahua, Mexico, 31217
Local Institution Active, not recruiting
San Luis Potosi, Mexico, 78200
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C. Active, not recruiting
San Luis Potosi, Mexico, 78213
Netherlands
Local Institution Active, not recruiting
Amsterdam, Netherlands, 1066 CX
Local Institution Completed
Amsterdam, Netherlands, 1081 BT
Local Institution Active, not recruiting
Breda, Netherlands, 4818 CK
Local Institution Active, not recruiting
Rotterdam, Netherlands, 3015 CE
Local Institution Active, not recruiting
Veldhoven, Netherlands, 5504 DB
Peru
Clinica Ricardo Palma Active, not recruiting
Lima, Peru, 27
Instituto Nacional De Enfermedades Neoplasicas Active, not recruiting
Lima, Peru, 34
Clinica San Felipe- Unidad de Oncologia Medica Completed
Lima, Peru
Instituto Oncologico Miraflores Active, not recruiting
Lima, Peru
Oncocenter Peru SAC - Oncosalud Active, not recruiting
Lima, Peru
Poland
Ambulatorium Chemioterapii Active, not recruiting
Bydgoszcz, Poland, 85-796
Wojewodzkie Centrum Onkologii Active, not recruiting
Gdansk, Poland, 80-19
Oddzial Onkologii I Radioterapii Szpital Morski Im. Pck Active, not recruiting
Gdynia, Poland, 81-519
Centrum Onkologii-Inst.Im.M.Sklodowskiej-Curie O.W Gliwicach Active, not recruiting
Gliwice, Poland, 44-101
Regionalny Osrodek Onkologiczny Active, not recruiting
Lodz, Poland, 93-513
Klinika Nowotworow Pluca i Klatki Piersiowej Active, not recruiting
Warszawa, Poland, 02-781
ORTHOS Szpital Wielospecjalistyczny Sp. z o.o. Active, not recruiting
Wroclaw, Poland, 52-229
Romania
Institute Of Oncology "Prof.Dr.Alexandru Trestioreanu" Bucha Active, not recruiting
Bucharest, Romania, 022328
Sf. Nectarie Oncology Center Active, not recruiting
Craiova, Romania, 200347
S.C. Radiotherapy Center Cluj S.R.L. Active, not recruiting
Floresti, Romania, 407280
Prof. Dr. Ion Chiricuta Institute Of Oncology Day Care Dep Active, not recruiting
Romania, Romania, 400015
Russian Federation
Local Institution Completed
Chelyabinsk, Russian Federation, 454048
Local Institution Active, not recruiting
Kazan, Russian Federation, 420029
Local Institution Active, not recruiting
Moscow, Russian Federation, 115478
Local Institution Active, not recruiting
Saint-Petersburg, Russian Federation, 197758
Local Institution Completed
St. Petersburg, Russian Federation, 194291
Local Institution Active, not recruiting
St. Petersburg, Russian Federation, 198255
Local Institution Active, not recruiting
Ufa, Russian Federation, 450054
Saudi Arabia
Local Institution Withdrawn
Riyadh 11426, Saudi Arabia, 11426
Local Institution Withdrawn
Riyadh-11211, Saudi Arabia, 11211
South Africa
Local Institution Completed
Johannesburg, Gauteng, South Africa, 2196
Local Institution Completed
Pretoria, Gauteng, South Africa, 0002
Local Institution Active, not recruiting
Saxonwold, Johannesburg, Gauteng, South Africa, 2196
Local Institution Completed
Vereeniging, South Africa, 1936
Spain
Local Institution Active, not recruiting
Majadahonda, Madrid, Spain, 28222
Local Institution Active, not recruiting
Badalona (Barcelona), Spain, 08916
Local Institution Active, not recruiting
Barcelona, Spain, 08035
Local Institution Active, not recruiting
Madrid, Spain, 28041
Local Institution Active, not recruiting
Sevilla, Spain, 41013
Local Institution Active, not recruiting
Valencia, Spain, 46014
Switzerland
Klinik Fur Onkologie Active, not recruiting
Basel, Switzerland, 4031
Kantonsspital Graubuenden Active, not recruiting
Chur, Switzerland, 7000
Centre hospitalier universitaire Vaudois (CHUV) Active, not recruiting
Lausanne, Switzerland, 1011
Local Institution Active, not recruiting
Winterthur, Switzerland, 8401
Taiwan
Local Institution Active, not recruiting
Taichung, Taiwan, 40705
Local Institution Active, not recruiting
Taipei, Taiwan, 10002
Local Institution Active, not recruiting
Taipei, Taiwan, 112
Local Institution Active, not recruiting
Taipei, Taiwan, 235
Local Institution Active, not recruiting
Tao-Yuan County, Taiwan, 333
Turkey
Local Institution Withdrawn
Ankara, Turkey, 06100
Local Institution Withdrawn
Antalya, Turkey, 07070
Local Institution Withdrawn
Kayseri, Turkey, 38039
United Arab Emirates
Local Institution Withdrawn
Al Ain, United Arab Emirates, 15258
United Kingdom
Local Institution Active, not recruiting
Middlesborough, Cleveland, United Kingdom, TS4 3BW
Local Institution Active, not recruiting
London, Greater London, United Kingdom, N18 1QX
Local Institution Active, not recruiting
London, Greater London, United Kingdom, SE1 9RT
Local Institution Active, not recruiting
London, Greater London, United Kingdom, SW3 6JJ
Local Institution Active, not recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Local Institution Active, not recruiting
Leicester, Leicestershire, United Kingdom, LE1 5WW
Local Institution Active, not recruiting
Birmingham, WEST Midlands, United Kingdom, B15 2TH
Local Institution Active, not recruiting
Cambridgeshire, United Kingdom, CB2 2QQ
Local Institution Active, not recruiting
Edinburgh, United Kingdom, EH4 2XU
Local Institution Completed
Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02477826     History of Changes
Other Study ID Numbers: CA209-227
2014-003630-23 ( EudraCT Number )
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Carboplatin
Nivolumab
Pemetrexed
Ipilimumab
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors