Lung Cancer Clinical Trial

A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery

Summary

The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) pathologically-confirmed NSCLC, according to 8th TNM classification. Participants who are not planned for potential curative surgical resection are eligible.
Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease

Exclusion Criteria:

Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation
Active infection requiring systemic therapy within 14 days prior to randomization
History of organ or tissue transplant that requires systemic use of immune suppressive agents
Prior thoracic radiotherapy

Other protocol-defined inclusion/exclusion criteria apply

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

888

Study ID:

NCT04026412

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 179 Locations for this study

See Locations Near You

Local Institution - 0119
La Jolla California, 92093, United States
Local Institution - 0207
San Francisco California, 94115, United States
Local Institution - 0166
San Francisco California, 94143, United States
Local Institution - 0129
Lone Tree Colorado, 80124, United States
Local Institution - 0233
Jacksonville Florida, 32207, United States
Local Institution - 0219
Orlando Florida, 32804, United States
Local Institution - 0039
Pensacola Florida, 32504, United States
Local Institution - 0125
Atlanta Georgia, 30322, United States
Local Institution - 0165
Augusta Georgia, 30912, United States
Local Institution - 0218
Edgewood Kentucky, 41017, United States
Local Institution - 0108
Bethesda Maryland, 20817, United States
Local Institution - 0116
Traverse City Michigan, 49684, United States
Local Institution - 0053
Cincinnati Ohio, 45220, United States
Local Institution - 0131
Cincinnati Ohio, 45236, United States
Local Institution - 0188
Cincinnati Ohio, 45267, United States
Local Institution - 0112
Cleveland Ohio, 44106, United States
Local Institution - 0124
Cleveland Ohio, 44106, United States
Local Institution - 0047
Cleveland Ohio, 44109, United States
Local Institution - 0123
Youngstown Ohio, 44501, United States
Local Institution - 0077
Charleston South Carolina, 29414, United States
Local Institution - 0191
Austin Texas, 78731, United States
CHI St. Joseph Cancer Center
Bryan Texas, 77802, United States
Local Institution - 0130
Dallas Texas, 75203, United States
Local Institution - 0071
Burlington Vermont, 05405, United States
Local Institution - 0044
Caba Buenos Aires, C1426, Argentina
Local Institution - 0045
Río Cuarto Cordoba, 5800, Argentina
Local Institution - 0043
Buenos Aires Distrito Federal, C1199, Argentina
Local Institution - 0042
Caba Distrito Federal, 1430, Argentina
Local Institution - 0031
Darlinghurst New South Wales, 2010, Australia
Local Institution - 0134
Gosford New South Wales, 2250, Australia
Local Institution - 0033
Kingswood New South Wales, 2747, Australia
Local Institution
Greenslopes Queensland, 4120, Australia
Local Institution - 0028
Adelaide South Australia, 5000, Australia
Local Institution - 0224
Ballarat Central Victoria, 3350, Australia
Local Institution - 0052
Melbourne Victoria, 3004, Australia
Local Institution
Melbourne Victoria, 3199, Australia
Local Institution - 0030
Murdoch Western Australia, 6150, Australia
Local Institution - 0003
Bruxelles , 1200, Belgium
Local Institution - 0001
Gent , 9000, Belgium
Local Institution - 0004
Liege , 4000, Belgium
Local Institution - 0002
Yvoir , B-553, Belgium
Local Institution - 0038
Ipatinga Minas Gerais, 35160, Brazil
Local Institution - 0234
Ijui RIO Grande DO SUL, 98700, Brazil
Local Institution - 0034
Porto Alegre RIO Grande DO SUL, 91350, Brazil
Local Institution - 0037
Blumenau Santa Catarina, 89010, Brazil
Local Institution - 0036
Barretos SAO Paulo, 14784, Brazil
Local Institution - 0035
Rio de Janeiro , 20230, Brazil
Local Institution - 0127
Kingston Ontario, K7L 2, Canada
Local Institution - 0078
Oshawa Ontario, L1G 2, Canada
Local Institution - 0237
Chicoutimi Quebec, G7H 5, Canada
Local Institution - 0070
Rimouski Quebec, G5L 5, Canada
Local Institution - 0092
Trois-Rivieres Quebec, G8Z 3, Canada
Local Institution - 0126
Quebec , G1V 4, Canada
Local Institution - 0041
Santiago Metropolitana, 84203, Chile
Local Institution - 0040
Vina del Mar Valparaiso, 25205, Chile
Local Institution - 0146
Beijing BEI, 10014, China
Local Institution - 0149
Chongqing Chongqing, 40003, China
Local Institution - 0179
Fuzhou Fujian, 35000, China
Local Institution - 0164
Xiamen Fujian, 36100, China
Local Institution - 0192
Guiyang Guizhou, 55000, China
Local Institution - 0147
Hankou Hubei, 43002, China
Local Institution - 0148
Wuhan Hubei, 21000, China
Local Institution - 0150
Wuhan Hubei, 43006, China
Local Institution - 0154
Changsha Hunan, 41001, China
Local Institution - 0139
Nanjing Jiangsu, 21000, China
Local Institution - 0178
Nanchang Jiangxi, 33000, China
Local Institution - 0170
Changchun Jilin, 13001, China
Local Institution - 0183
Changchun Jilin, 13002, China
Local Institution - 0180
Gongzhuling Jilin, 13200, China
Local Institution - 0138
Jinan Shandong, 25011, China
Local Institution - 0145
Shanghai Shanghai, 20044, China
Local Institution - 0186
Chengdu Sichuan, 61004, China
Local Institution - 0140
Hangzhou Zhejiang, 31000, China
Local Institution - 0184
Linhai Zhejiang, 31700, China
Local Institution - 0189
Chengdu , 0, China
Local Institution - 0086
Bordeaux , 33076, France
Local Institution - 0087
Dijon , 21000, France
Local Institution - 0081
Lyon , 69008, France
Local Institution - 0082
Montpellier , 34070, France
Local Institution - 0084
Nantes , 44000, France
Local Institution - 0090
Paris Cedex 14 , 75679, France
Local Institution - 0083
Paris Cedex 5 , 75248, France
Local Institution - 0227
Paris , 75018, France
Local Institution - 0091
Paris , 75020, France
Local Institution - 0089
Tours Cedex 09 , 37044, France
Local Institution - 0060
Berlin , 14165, Germany
Local Institution - 0063
Essen , 45136, Germany
Local Institution - 0076
Grosshansdorf , 22927, Germany
Local Institution - 0101
Hamm , 59063, Germany
Local Institution - 0073
Heidelberg , 69126, Germany
Local Institution - 0061
Immenhausen , 34376, Germany
Local Institution - 0062
Kempten , 87439, Germany
Local Institution - 0075
Loewenstein , 74245, Germany
Local Institution - 0109
Mainz , 55131, Germany
Local Institution - 0072
Stuttgart , 70376, Germany
Local Institution - 0161
Athens , 115 2, Greece
Local Institution - 0135
Athens , 11527, Greece
Local Institution - 0136
Larissa , 41110, Greece
Local Institution - 0162
N.Kifissia , 14564, Greece
Local Institution - 0024
Dublin 8 Dublin, , Ireland
Local Institution - 0023
Dublin , 00004, Ireland
Local Institution - 0068
Brescia , 25123, Italy
Local Institution - 0049
Catania , 95100, Italy
Local Institution - 0051
Catanzaro , 88100, Italy
Local Institution - 0050
Lucca , 55100, Italy
Local Institution - 0115
Milano , 20141, Italy
Local Institution - 0114
Monza , 20900, Italy
Local Institution - 0048
Perugia , 06132, Italy
Local Institution - 0204
Nagoya Aichi, 46486, Japan
Local Institution - 0212
Fukuoka-shi Fukuoka, 81285, Japan
Local Institution - 0211
Kurume-shi Fukuoka, 83000, Japan
Local Institution - 0197
Ota-shi Gunma, 37385, Japan
Local Institution - 0195
Sapporo-shi Hokkaido, 00308, Japan
Local Institution - 0206
Kobe Hyogo, 65000, Japan
Local Institution - 0203
Kanazawa-shi Ishikawa, 92086, Japan
Local Institution - 0216
Yokohama-shi Kanagawa, 22108, Japan
Local Institution - 0201
Yokohama-Shi Kanagawa, 23600, Japan
Local Institution - 0217
Yokohama Kanagawa, 24185, Japan
Local Institution - 0196
Sendai-shi Miyagi, 98008, Japan
Local Institution - 0202
Niigata-shi Niigata, 95185, Japan
Local Institution - 0205
Osaka-shi Osaka, 54585, Japan
Local Institution - 0210
Osakasayama Osaka, 589-8, Japan
Local Institution - 0198
Hidaka-shi Saitama, 35012, Japan
Local Institution - 0174
Kitaadachi-gun Saitama, 36208, Japan
Local Institution - 0199
Bunkyo-ku Tokyo, 11386, Japan
Local Institution - 0200
Chuo-ku Tokyo, 10400, Japan
Local Institution - 0175
Wakayama-shi Wakayama, 641-8, Japan
Local Institution - 0232
Ube Yamaguchi, 755-0, Japan
Local Institution - 0167
Cheongju-si, Chungcheonbuk-do, , 361-7, Korea, Republic of
Local Institution - 0152
Seoul , 03722, Korea, Republic of
Local Institution - 0168
Seoul , 06351, Korea, Republic of
Local Institution - 0027
La Paz BAJA Californa SUR, 23040, Mexico
Local Institution - 0067
Df Distrito Federal, 06720, Mexico
Local Institution - 0080
Guadalajara Jalisco, 44340, Mexico
Local Institution - 0014
Monterrey Nuevo LEON, 64060, Mexico
Local Institution - 0015
Culiacan Sinaloa, 80230, Mexico
Local Institution - 0006
Amsterdam , 1081H, Netherlands
Local Institution - 0025
Arnhem , 6815 , Netherlands
Local Institution
Leiden , 2333Z, Netherlands
Local Institution - 0005
Maastrict , 6229 , Netherlands
Local Institution - 0026
Veldhoven , 5504 , Netherlands
Local Institution - 0107
Bydgoszcz , 85796, Poland
Local Institution - 0102
Gdansk , 80-21, Poland
Local Institution - 0104
Krakow , 31-82, Poland
Local Institution - 0235
Tomaszow Mazowiecki , 97-20, Poland
Local Institution - 0120
Hato Rey , 00917, Puerto Rico
GCM Medical Group
San Juan , 917, Puerto Rico
Local Institution - 0018
Bucharest , 02232, Romania
Local Institution - 0222
Bucuresti , 02254, Romania
Local Institution - 0019
Cluj-Napoca , 40001, Romania
Local Institution - 0020
Constanta , 90059, Romania
Local Institution - 0017
Craiova , 20034, Romania
Local Institution - 0021
Floresti/ Cluj , 40728, Romania
Local Institution
Moscow , 10522, Russian Federation
Local Institution
Moscow , 11547, Russian Federation
Local Institution
Moscow , 12536, Russian Federation
Local Institution
St. Petersburg , 19775, Russian Federation
Local Institution - 0171
Singapore , 16961, Singapore
Local Institution - 0106
Barcelona , 8025, Spain
Local Institution - 0099
Hospitalet de Llobregat , 08907, Spain
Local Institution - 0096
Madrid , 28007, Spain
Local Institution - 0095
Madrid , 28046, Spain
Local Institution - 0098
Pamplona , 31008, Spain
Local Institution - 0105
Santiago de Compostela , 15706, Spain
Local Institution - 0097
Sevilla , 41013, Spain
Local Institution - 0100
Zaragoza , 50009, Spain
Local Institution - 0065
Goteborg Vastra Gotalands Lan, 41345, Sweden
Local Institution - 0064
Stockholm , 171 7, Sweden
Local Institution - 0057
Basel , 4031, Switzerland
Local Institution - 0058
Lausanne , 1011, Switzerland
Local Institution - 0059
St.Gallen , 9007, Switzerland
Local Institution - 0056
Zuerich , 8091, Switzerland
Local Institution - 0208
KaohsiungCity , 83301, Taiwan
Local Institution - 0214
New Taipei City , 235, Taiwan
Local Institution - 0209
Tainan , 704, Taiwan
Local Institution - 0133
Taipei City , 100, Taiwan
Local Institution - 0213
Taipei , 10099, Taiwan
Local Institution - 0143
Taipei , 112, Taiwan
Local Institution - 0010
Poole Dorset, BH15 , United Kingdom
Local Institution - 0012
Swansea Glamorgan, SA2 8, United Kingdom
Local Institution - 0054
Aberdeen , AB25 , United Kingdom
Local Institution - 0007
Bebington , CH63 , United Kingdom
Local Institution - 0009
Hull , HU16 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

888

Study ID:

NCT04026412

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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