Lung Cancer Clinical Trial

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An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy

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Summary

In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subjects with histologically or cytologically confirmed extensive stage disease SCLC
Ongoing response of stable disease or better following 4 cycles of platinum-based first line chemotherapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

Subjects with symptomatic Central Nervous System (CNS) metastases
Subjects receiving consolidative chest radiation
Subjects with active, known, or suspected autoimmune disease are excluded
All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline

Other protocol-defined inclusion/exclusion criteria apply

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

907

Study ID:

NCT02538666

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 188 Locations for this study

See Locations Near You

Local Institution - 0003
Sacramento California, 95816, United States
Local Institution - 0202
New Haven Connecticut, 06520, United States
Local Institution - 0127
Fort Myers Florida, 33901, United States
Local Institution - 0007
Jacksonville Florida, 32256, United States
Local Institution - 0128
Saint Petersburg Florida, 33705, United States
Local Institution - 0010
Atlanta Georgia, 30322, United States
Local Institution - 0013
Indianapolis Indiana, 46237, United States
Local Institution - 0061
Fairway Kansas, 66205, United States
Local Institution - 0012
Wichita Kansas, 67214, United States
Local Institution - 0032
Lexington Kentucky, 40503, United States
Local Institution - 0051
Baltimore Maryland, 21287, United States
Local Institution - 0107
Boston Massachusetts, 02215, United States
Local Institution - 0207
Boston Massachusetts, 02215, United States
Local Institution - 0015
Saint Louis Missouri, 63110, United States
Local Institution - 0008
New York New York, 10065, United States
Local Institution - 0014
Durham North Carolina, 27710, United States
Local Institution - 0016
Winston-Salem North Carolina, 27103, United States
Local Institution - 0215
Fargo North Dakota, 58102, United States
Local Institution - 0129
Cincinnati Ohio, 45242, United States
Local Institution - 0009
Columbus Ohio, 43210, United States
Local Institution - 0001
Portland Oregon, 97213, United States
Local Institution - 0034
Portland Oregon, 97239, United States
Local Institution - 0004
Allentown Pennsylvania, 18103, United States
Local Institution - 0002
Sayre Pennsylvania, 18840, United States
Local Institution - 0005
Charleston South Carolina, 29425, United States
Local Institution - 0213
Sioux Falls South Dakota, 57104, United States
Local Institution - 0011
Salt Lake City Utah, 84112, United States
Local Institution - 0006
Richmond Virginia, 23226, United States
Local Institution - 0110
Berazategui Buenos Aires, 1880, Argentina
Local Institution - 0088
Capital Federal Buenos Aires, 1426, Argentina
Local Institution - 0109
Ciudad Autonoma De Buenos Aire Buenos Aires, 1181, Argentina
Local Institution - 0188
Cordoba , 5004, Argentina
Local Institution - 0029
Tucuman , 4000, Argentina
Local Institution
Kogarah New South Wales, , Australia
Local Institution
Wollongong New South Wales, 2500, Australia
Local Institution
Birtinya Queensland, 4575, Australia
Princess Alexandra Hospital
Brisbane Queensland, 4102, Australia
Local Institution - 0137
Adelaide South Australia, 5000, Australia
Local Institution - 0035
East Melbourne Victoria, 3165, Australia
Local Institution - 0174
Innsbruck , 6020, Austria
Local Institution - 0173
Salzburg , 5020, Austria
Local Institution - 0172
Wien , 1130, Austria
Local Institution - 0057
Brussels , 1090, Belgium
Local Institution - 0059
Charleroi , 6000, Belgium
Local Institution - 0060
Roeselare , 8800, Belgium
Local Institution - 0067
Fortaleza Ceara, 60430, Brazil
Local Institution - 0068
Belo Horizonte Minas Gerais, 30110, Brazil
Local Institution - 0063
Ijui RIO Grande DO SUL, 98700, Brazil
Local Institution - 0064
Porto Alegre RIO Grande DO SUL, 90610, Brazil
Local Institution - 0017
Itajai Santa Catarina, 88301, Brazil
Local Institution - 0081
Barretos Sao Paulo, 14784, Brazil
Local Institution
Rio de Janeiro , 22793, Brazil
Local Institution
Salvador , 40170, Brazil
Local Institution - 0094
Edmonton Alberta, T6G 1, Canada
Local Institution - 0136
Moncton New Brunswick, E1C 6, Canada
Local Institution - 0123
Oshawa Ontario, L1G 2, Canada
Local Institution - 0102
Sudbury Ontario, P3E 5, Canada
Local Institution - 0111
Windsor Ontario, N8W 1, Canada
Local Institution - 0238
Hefei Anhui, 23000, China
Local Institution - 0243
Hefei Anhui, 23002, China
Local Institution
Beijing Beijing, 10000, China
Local Institution
Beijing Beijing, 10014, China
Local Institution - 0221
Harbin Heilongjiang, 15504, China
Local Institution - 0244
Wuhang Hubei, 43003, China
Local Institution - 0248
Nantong Jiangsu, 22636, China
Local Institution - 0230
Nanchang Jiangxi, 33000, China
Local Institution
Changchun Jilin, 13002, China
Local Institution - 0237
Shenyang Liaoning, 11004, China
Local Institution - 0220
Shanghai Shanghai, 20003, China
Local Institution - 0228
Shanghai Shanghai, 20003, China
Local Institution - 0233
Shanghai Shanghai, 20003, China
Local Institution - 0245
Shanghai Shanghai, 20043, China
Local Institution - 0232
Kunming Yunnan, 65011, China
Local Institution - 0239
Hangzhou Zhejiang, 31000, China
Local Institution - 0227
Hangzhou Zhejiang, 31001, China
Local Institution - 0246
Wenzhou Zhejiang, 32500, China
Local Institution - 0247
Changsha , 0, China
Local Institution - 0240
Guangzhou , 51051, China
Local Institution
Monteria Cordoba, , Colombia
Local Institution - 0078
Bogota , 0, Colombia
Local Institution
Medellin , MEDEL, Colombia
Local Institution - 0044
Oulu , 90029, Finland
Local Institution - 0043
Tampere , 33521, Finland
Local Institution - 0045
Turku , FIN-2, Finland
Local Institution - 0046
Vaasa , 65130, Finland
Local Institution - 0149
Strasbourg Alsace, 67091, France
Local Institution - 0208
Avignon Cedes 9 , 84918, France
Local Institution - 0099
Lyon Cedex 08 , 69373, France
Local Institution - 0098
Marseille Cedex 20 , 13915, France
Local Institution - 0097
Paris Cedex 20 , 75970, France
Local Institution - 0095
Pierre Benite , 69495, France
Local Institution - 0100
Rennes Cedex 9 , 35033, France
Local Institution - 0150
Saint Herblain , 44805, France
Local Institution - 0096
Toulouse , 31059, France
Local Institution - 0171
Augsburg , 86156, Germany
Local Institution - 0170
Bad Berka , 99437, Germany
Local Institution - 0168
Berlin , 14165, Germany
Local Institution - 0164
Bochum , 44791, Germany
Local Institution - 0166
Gauting , 82131, Germany
Local Institution - 0165
Grosshansdorf , 22927, Germany
Local Institution - 0169
Immenhausen , 34376, Germany
Local Institution - 0167
Tübingen , 72076, Germany
Local Institution - 0080
N.Kifissia , 14564, Greece
Interbalkan European Medical Center
Thessaloniki , 57001, Greece
Local Institution - 0052
Hong Kong , 0, Hong Kong
Local Institution - 0161
Wilton Cork, 0, Ireland
Local Institution - 0175
Dublin , 24, Ireland
Local Institution
Dublin , 4, Ireland
Local Institution - 0162
Galway , ST4 6, Ireland
Local Institution - 0214
Limerick , 0, Ireland
Local Institution
Haifa , 31096, Israel
Local Institution - 0093
Jerusalem , 91031, Israel
Local Institution
Petach Tikva , 49100, Israel
Local Institution - 0090
Tel Aviv , 64239, Israel
Local Institution - 0089
Zerifin , 70300, Israel
Local Institution - 0027
Milan Lombardia, 20141, Italy
Local Institution - 0026
Avellino , 83100, Italy
Local Institution - 0025
Bologna , 40138, Italy
Local Institution - 0112
Messina , 98158, Italy
Local Institution - 0082
Perugia , 06132, Italy
Local Institution - 0139
Kashiwa-shi Chiba, 27785, Japan
Local Institution - 0142
Matsuyama-shi Ehime, 79102, Japan
Local Institution - 0146
Fukuoka-shi Fukuoka, 81285, Japan
Local Institution - 0200
Kurume-shi Fukuoka, 83000, Japan
Local Institution - 0198
Gifu-shi Gifu, 50085, Japan
Local Institution - 0143
Sapporo-shi Hokkaido, 06086, Japan
Local Institution - 0076
Kobe-shi Hyogo, 65000, Japan
Local Institution - 0138
Kanazawa-shi Ishikawa, 92086, Japan
Local Institution - 0072
Yokohama-shi Kanagawa, 24085, Japan
Local Institution - 0070
Sendai-shi Miyagi, 98008, Japan
Local Institution - 0069
Sendai-shi Miyagi, 98085, Japan
Local Institution - 0077
Kurashiki-shi Okayama, 71086, Japan
Local Institution
Hirakata-shi Osaka, 57311, Japan
Local Institution - 0075
Osaka-sayama-shi Osaka, 58985, Japan
Local Institution - 0145
Osaka-shi Osaka, 53400, Japan
Local Institution - 0083
Takatsuki-shi Osaka, 56986, Japan
Local Institution - 0193
Hidaka Saitama, 350-1, Japan
Local Institution - 0141
Bunkyo-ku Tokyo, 113-8, Japan
Local Institution - 0071
Chuo-ku Tokyo, 10400, Japan
Local Institution - 0140
Koto-ku Tokyo, 13585, Japan
Local Institution - 0144
Shinjuku-ku Tokyo, 16000, Japan
Local Institution - 0216
Wakayama , 641-8, Japan
Local Institution - 0047
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Local Institution - 0024
Suwon KyÇ’nggi-do, 16499, Korea, Republic of
Local Institution - 0021
Gangnam-gu , 06351, Korea, Republic of
Local Institution - 0022
Seoul , 03722, Korea, Republic of
Local Institution - 0154
Seoul , 05505, Korea, Republic of
Local Institution - 0019
Mexico Distrito Federal, 14050, Mexico
Local Institution - 0020
Leon de los Aldama Guanajuato, 37000, Mexico
Local Institution - 0028
Monterrey Nuevo Leon, 64000, Mexico
Local Institution - 0135
Queretaro , 76090, Mexico
Local Institution - 0158
's-Hertogenbosch , 5223 , Netherlands
Local Institution
Eindhoven , 5623 , Netherlands
Local Institution - 0159
Rotterdam , 3000 , Netherlands
Local Institution
Miraflores Lima, 18, Peru
Local Institution
Lima , 27, Peru
Local Institution
Lima , 34, Peru
Local Institution - 0041
Gdansk , 80-19, Poland
Local Institution - 0054
Gdynia , 81-51, Poland
Local Institution - 0053
Olsztyn , 10-35, Poland
Local Institution - 0187
Warszawa , 02-78, Poland
Local Institution - 0199
Bucharest , 01099, Romania
Local Institution - 0186
Bucharest , 02012, Romania
Local Institution - 0182
Craiova , 20034, Romania
Local Institution - 0178
Lasi , 70010, Romania
Local Institution - 0212
Romania , 40001, Romania
Local Institution - 0181
Timisoara, Timis , 30023, Romania
Local Institution - 0148
Moscow , 10522, Russian Federation
Local Institution - 0217
Moscow , 11547, Russian Federation
Local Institution - 0209
Moscow , 12130, Russian Federation
Local Institution - 0157
St Petersburg , 19775, Russian Federation
Local Institution - 0115
St Petersburg , 19825, Russian Federation
Local Institution - 0116
St. Petersburg , 19429, Russian Federation
Local Institution - 0050
Singapore , 16961, Singapore
Local Institution - 0087
Sandton Gauteng, 2199, South Africa
Local Institution - 0084
Cape Town Western Cape, 7570, South Africa
Local Institution - 0085
Cape Town Western CAPE, 7700, South Africa
Local Institution - 0086
George Western CAPE, 6530, South Africa
Local Institution - 0132
Barcelona , 08035, Spain
Local Institution
Barcelona , 08036, Spain
Local Institution
Madrid , 28040, Spain
Local Institution
Malaga , 29011, Spain
Local Institution
Sevilla , 41013, Spain
Local Institution - 0124
Lund , 221 8, Sweden
Local Institution - 0185
Uppsala , 751 8, Sweden
Local Institution - 0179
Aarau , 5001, Switzerland
Local Institution - 0180
Geneve , 1205, Switzerland
Local Institution - 0191
St. Gallen , 9007, Switzerland
Local Institution - 0049
Tainan TNN, 704, Taiwan
Local Institution - 0048
Taoyuan , 333, Taiwan
Local Institution - 0153
Truro Cornwall, TR1 3, United Kingdom
Local Institution - 0118
London Greater London, NW1 2, United Kingdom
Local Institution - 0201
London Greater London, SW3 6, United Kingdom
Local Institution - 0121
Wirral Lancashire, CH63 , United Kingdom
Local Institution - 0152
Oxford Oxfordshire, OX3 7, United Kingdom
Local Institution - 0151
Sutton Surrey, SM2 5, United Kingdom
Local Institution - 0192
Sheffield , S10 2, United Kingdom
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How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

907

Study ID:

NCT02538666

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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