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
NCT ID: NCT04026412
Last Updated: 2025-07-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
925 participants
INTERVENTIONAL
2019-10-08
2024-11-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: nivolumab + CCRT + ipilimumab
Concurrent chemoradiotherapy (CCRT)
nivolumab
Specified dose on specified days
ipilimumab
Specified dose on specified days
Arm B: nivolumab + CCRT
Concurrent chemoradiotherapy (CCRT)
nivolumab
Specified dose on specified days
Arm C: CCRT + durvalumab
Concurrent chemoradiotherapy (CCRT)
durvalumab
Specified dose on specified days
Interventions
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nivolumab
Specified dose on specified days
ipilimumab
Specified dose on specified days
durvalumab
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0119
La Jolla, California, United States
Local Institution - 0207
San Francisco, California, United States
Local Institution - 0166
San Francisco, California, United States
Local Institution - 0129
Lone Tree, Colorado, United States
Local Institution - 0233
Jacksonville, Florida, United States
Local Institution - 0219
Orlando, Florida, United States
Local Institution - 0039
Pensacola, Florida, United States
Local Institution - 0125
Atlanta, Georgia, United States
Local Institution - 0165
Augusta, Georgia, United States
Local Institution - 0218
Edgewood, Kentucky, United States
Local Institution - 0108
Bethesda, Maryland, United States
Local Institution - 0116
Traverse City, Michigan, United States
Local Institution - 0053
Cincinnati, Ohio, United States
Local Institution - 0131
Cincinnati, Ohio, United States
Local Institution - 0188
Cincinnati, Ohio, United States
Local Institution - 0112
Cleveland, Ohio, United States
Local Institution - 0124
Cleveland, Ohio, United States
Local Institution - 0047
Cleveland, Ohio, United States
Local Institution - 0123
Youngstown, Ohio, United States
Local Institution - 0077
Charleston, South Carolina, United States
Local Institution - 0191
Austin, Texas, United States
Local Institution - 0079
Bryan, Texas, United States
Local Institution - 0130
Dallas, Texas, United States
Local Institution - 0071
Burlington, Vermont, United States
Local Institution - 0044
CABA, Buenos Aires, Argentina
Local Institution - 0045
Río Cuarto, Córdoba Province, Argentina
Local Institution - 0043
Buenos Aires, Distrito Federal, Argentina
Local Institution - 0042
Caba, Distrito Federal, Argentina
Local Institution - 0031
Darlinghurst, New South Wales, Australia
Local Institution - 0134
Gosford, New South Wales, Australia
Local Institution - 0033
Kingswood, New South Wales, Australia
Local Institution - 0029
Greenslopes, Queensland, Australia
Local Institution - 0028
Adelaide, South Australia, Australia
Local Institution - 0224
Ballarat Central, Victoria, Australia
Local Institution - 0052
Melbourne, Victoria, Australia
Local Institution
Melbourne, Victoria, Australia
Local Institution - 0030
Murdoch, Western Australia, Australia
Local Institution - 0003
Brussels, , Belgium
Local Institution - 0001
Ghent, , Belgium
Local Institution - 0004
Liège, , Belgium
Local Institution - 0002
Yvoir, , Belgium
Local Institution - 0038
Ipatinga, Minas Gerais, Brazil
Local Institution - 0234
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0034
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0037
Blumenau, Santa Catarina, Brazil
Local Institution - 0036
Barretos, São Paulo, Brazil
Local Institution - 0035
Rio de Janeiro, , Brazil
Local Institution - 0127
Kingston, Ontario, Canada
Local Institution - 0078
Oshawa, Ontario, Canada
Local Institution - 0237
Chicoutimi, Quebec, Canada
Local Institution - 0126
Québec, Quebec, Canada
Local Institution - 0070
Rimouski, Quebec, Canada
Local Institution - 0092
Trois-Rivières, Quebec, Canada
Local Institution - 0040
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0041
Santiago, Santiago Metropolitan, Chile
Local Institution - 0146
Beijing, BEI, China
Local Institution - 0149
Chongqing, Chongqing Municipality, China
Local Institution - 0179
Fuzhou, Fujian, China
Local Institution - 0164
Xiamen, Fujian, China
Local Institution - 0192
Guiyang, Guizhou, China
Local Institution - 0147
Hankou, Hubei, China
Local Institution - 0148
Wuhan, Hubei, China
Local Institution - 0150
Wuhan, Hubei, China
Local Institution - 0154
Changsha, Hunan, China
Local Institution - 0139
Nanjing, Jiangsu, China
Local Institution - 0178
Nanchang, Jiangxi, China
Local Institution - 0170
Changchun, Jilin, China
Local Institution - 0183
Changchun, Jilin, China
Local Institution - 0180
Gongzhuling, Jilin, China
Local Institution - 0138
Jinan, Shandong, China
Local Institution - 0145
Shanghai, Shanghai Municipality, China
Local Institution - 0186
Chengdu, Sichuan, China
Local Institution - 0189
Chengdu, Sichuan, China
Local Institution - 0140
Hangzhou, Zhejiang, China
Local Institution - 0184
Linhai, Zhejiang, China
Local Institution - 0086
Bordeaux, , France
Local Institution - 0087
Dijon, , France
Local Institution - 0081
Lyon, , France
Local Institution - 0082
Montpellier, , France
Local Institution - 0084
Nantes, , France
Local Institution - 0227
Paris, , France
Local Institution - 0091
Paris, , France
Local Institution - 0083
Paris, , France
Local Institution - 0090
Paris, , France
Local Institution - 0089
Tours, , France
Local Institution - 0060
Berlin, , Germany
Local Institution - 0063
Essen, , Germany
Local Institution - 0076
Großhansdorf, , Germany
Local Institution - 0101
Hamm, , Germany
Local Institution - 0073
Heidelberg, , Germany
Local Institution - 0061
Immenhausen, , Germany
Local Institution - 0062
Kempten, , Germany
Local Institution - 0075
Löwenstein, , Germany
Local Institution - 0109
Mainz, , Germany
Local Institution - 0072
Stuttgart, , Germany
Local Institution - 0161
Athens, , Greece
Local Institution - 0135
Athens, , Greece
Local Institution - 0136
Larissa, , Greece
Local Institution - 0162
N.Kifissia, , Greece
Local Institution - 0024
Dublin, Dublin, Ireland
Local Institution - 0023
Dublin, , Ireland
Local Institution - 0114
Monza (MB), Monza (MB), Italy
Local Institution - 0068
Brescia, , Italy
Aou Policlinico V. Emanuele Di Catania
Catania, , Italy
Azienda Ospedaliero-Universitaria Mater Domini
Catanzaro, , Italy
Local Institution - 0050
Lucca, , Italy
Local Institution - 0115
Milan, , Italy
Local Institution - 0048
Perugia, , Italy
Local Institution - 0204
Nagoya, Aichi-ken, Japan
Local Institution - 0212
Fukuoka, Fukuoka, Japan
Local Institution - 0211
Kurume-shi, Fukuoka, Japan
Local Institution - 0197
Ōta, Gunma, Japan
Local Institution - 0195
Sapporo, Hokkaido, Japan
Local Institution - 0206
Kobe, Hyōgo, Japan
Local Institution - 0203
Kanazawa, Ishikawa-ken, Japan
Local Institution - 0216
Yokohama, Kanagawa, Japan
Local Institution - 0201
Yokohama, Kanagawa, Japan
Local Institution - 0217
Yokohama, Kanagawa, Japan
Local Institution - 0196
Sendai, Miyagi, Japan
Local Institution - 0202
Niigata, Niigata, Japan
Local Institution - 0205
Osaka, Osaka, Japan
Local Institution - 0210
Sayama, Osaka, Japan
Local Institution - 0198
Hidaka-shi, Saitama, Japan
Local Institution - 0174
Kitaadachi-gun, Saitama, Japan
Local Institution - 0199
Bunkyo-ku, Tokyo, Japan
Local Institution - 0200
Chuo-ku, Tokyo, Japan
Local Institution - 0232
Ube, Yamaguchi, Japan
Local Institution - 0175
Wakayama, , Japan
Local Institution - 0027
La Paz, BAJA Californa SUR, Mexico
Local Institution - 0080
Guadalajara, Jalisco, Mexico
Local Institution - 0067
Df, Mexico City, Mexico
Local Institution - 0014
Monterrey, Nuevo León, Mexico
Local Institution - 0015
Culiacán, Sinaloa, Mexico
Local Institution - 0006
Amsterdam, , Netherlands
Local Institution - 0025
Arnhem, , Netherlands
Local Institution - 0240
Leiden, , Netherlands
Local Institution - 0005
Maastrict, , Netherlands
Local Institution - 0026
Veldhoven, , Netherlands
Local Institution - 0107
Bydgoszcz, , Poland
Local Institution - 0102
Gdansk, , Poland
Local Institution - 0104
Krakow, , Poland
Local Institution - 0235
Tomaszów Mazowiecki, , Poland
Local Institution - 0120
Hato Rey, , Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, , Puerto Rico
Local Institution - 0018
Bucharest, , Romania
Local Institution - 0222
Bucharest, , Romania
Local Institution - 0019
Cluj-Napoca, , Romania
Local Institution - 0020
Constanța, , Romania
Local Institution - 0017
Craiova, , Romania
Local Institution - 0021
Floresti/ Cluj, , Romania
Local Institution
Moscow, , Russia
Local Institution
Moscow, , Russia
Local Institution
Moscow, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution - 0171
Singapore, , Singapore
Local Institution - 0167
Cheongju-si, Chungcheonbuk-do,, , South Korea
Local Institution - 0152
Seoul, , South Korea
Local Institution - 0168
Seoul, , South Korea
Local Institution - 0106
Barcelona, , Spain
Local Institution - 0099
L'Hospitalet de Llobregat, , Spain
Local Institution - 0096
Madrid, , Spain
Local Institution - 0095
Madrid, , Spain
Local Institution - 0098
Pamplona, , Spain
Local Institution - 0105
Santiago de Compostela, , Spain
Local Institution - 0097
Seville, , Spain
Local Institution - 0100
Zaragoza, , Spain
Local Institution - 0065
Gothenburg, Västra Götaland County, Sweden
Local Institution - 0064
Stockholm, , Sweden
Local Institution - 0057
Basel, , Switzerland
Local Institution - 0058
Lausanne, , Switzerland
Local Institution - 0059
Sankt Gallen, , Switzerland
Local Institution - 0056
Zurich, , Switzerland
Local Institution - 0208
KaohsiungCity, , Taiwan
Local Institution - 0214
New Taipei City, , Taiwan
Local Institution - 0209
Tainan City, , Taiwan
Local Institution - 0213
Taipei, , Taiwan
Local Institution - 0133
Taipei, , Taiwan
Local Institution - 0143
Taipei, , Taiwan
Local Institution - 0010
Poole, Dorset, United Kingdom
Local Institution - 0012
Swansea, Glamorgan, United Kingdom
Local Institution - 0054
Aberdeen, , United Kingdom
Local Institution - 0007
Bebington, , United Kingdom
Local Institution - 0009
Hull, , United Kingdom
Countries
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References
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De Ruysscher D, Ramalingam S, Urbanic J, Gerber DE, Tan DSW, Cai J, Li A, Peters S. CheckMate 73L: A Phase 3 Study Comparing Nivolumab Plus Concurrent Chemoradiotherapy Followed by Nivolumab With or Without Ipilimumab Versus Concurrent Chemoradiotherapy Followed by Durvalumab for Previously Untreated, Locally Advanced Stage III Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2022 May;23(3):e264-e268. doi: 10.1016/j.cllc.2021.07.005. Epub 2021 Jul 19.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2019-001222-98
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-73L
Identifier Type: -
Identifier Source: org_study_id
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