A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT02998528
Last Updated: 2026-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
505 participants
INTERVENTIONAL
2017-03-04
2024-12-06
Brief Summary
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This study has multiple primary endpoints.
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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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Platinum doublet chemotherapy
Specified dose on specified days
Cisplatin
Specified dose on specified days
Vinorelbine
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Docetaxel
Specified dose on specified days
Pemetrexed
Specified dose on specified days
Carboplatin
Specified dose on specified days
Paclitaxel
Specified dose on specified days
Nivolumab plus platinum doublet chemotherapy
Specified dose on specified days
Nivolumab
Specified dose on specified days
Cisplatin
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Pemetrexed
Specified dose on specified days
Carboplatin
Specified dose on specified days
Paclitaxel
Specified dose on specified days
Nivolumab plus Ipilimumab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Ipilimumab
This arm is closed and no longer enrolling patients.
Interventions
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Nivolumab
Specified dose on specified days
Cisplatin
Specified dose on specified days
Vinorelbine
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Docetaxel
Specified dose on specified days
Pemetrexed
Specified dose on specified days
Carboplatin
Specified dose on specified days
Paclitaxel
Specified dose on specified days
Ipilimumab
This arm is closed and no longer enrolling patients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Lung function capacity capable of tolerating the proposed lung surgery
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Available tissue of primary lung tumor
Exclusion Criteria
* Participants with active, known or suspected autoimmune disease
* Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
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 - 0121
Glendale, Arizona, United States
Local Institution - 0081
Los Angeles, California, United States
Local Institution - 0025
Denver, Colorado, United States
Local Institution - 0007
Plainville, Connecticut, United States
Local Institution - 0173
Hollywood, Florida, United States
Local Institution - 0136
Miami, Florida, United States
Local Institution - 0054
Orlando, Florida, United States
Orlando Health, Inc.
Orlando, Florida, United States
Indian River Medical Center
Vero Beach, Florida, United States
Northwest Georgia Oncology Center, P.C.
Marietta, Georgia, United States
Local Institution - 0015
Chicago, Illinois, United States
Local Institution - 0002
Chicago, Illinois, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Local Institution - 0171
Fort Wayne, Indiana, United States
Local Institution - 0170
Lexington, Kentucky, United States
Local Institution - 0186
Louisville, Kentucky, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Local Institution - 0151
Baltimore, Maryland, United States
Local Institution - 0001
Baltimore, Maryland, United States
Local Institution - 0008
Boston, Massachusetts, United States
Southcoast Center For Cancer
Fairhaven, Massachusetts, United States
Local Institution - 0006
Newton, Massachusetts, United States
Local Institution - 0012
Detroit, Michigan, United States
Local Institution - 0090
Hattiesburg, Mississippi, United States
St Vincent Frontier Cancer Center
Billings, Montana, United States
Local Institution - 0032
Las Vegas, Nevada, United States
Local Institution - 0009
Hackensack, New Jersey, United States
Valley Hospital Luckow Pavili
Westwood, New Jersey, United States
Local Institution - 0027
Albany, New York, United States
Local Institution - 0011
New York, New York, United States
Local Institution - 0140
High Point, North Carolina, United States
Christ Hospital
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Local Institution - 0149
Zanesville, Ohio, United States
Kaiser Permanente
Portland, Oregon, United States
Local Institution - 0139
Portland, Oregon, United States
Local Institution - 0010
Philadelphia, Pennsylvania, United States
Local Institution - 0018
Pittsburgh, Pennsylvania, United States
Local Institution - 0013
Charleston, South Carolina, United States
Local Institution - 0021
Charleston, South Carolina, United States
Local Institution - 0146
Greenville, South Carolina, United States
Local Institution - 0092
Nashville, Tennessee, United States
Local Institution - 0005
Nashville, Tennessee, United States
Local Institution - 0035
Austin, Texas, United States
Texas Oncology
Bedford, Texas, United States
Local Institution - 0153
Fort Bliss, Texas, United States
Local Institution - 0106
Houston, Texas, United States
Southwest Cancer Center
Lubbock, Texas, United States
Texas Cancer Center - Sherman
Sherman, Texas, United States
Local Institution - 0143
Tyler, Texas, United States
Local Institution - 0026
Waco, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Local Institution - 0003
Salt Lake City, Utah, United States
Southwest Regional Cancer Clinic
St. George, Utah, United States
Local Institution - 0135
Burlington, Vermont, United States
Local Institution - 0125
Fairfax, Virginia, United States
Local Institution - 0198
Fredericksburg, Virginia, United States
Local Institution - 0022
Capital Federal, Buenos Aires, Argentina
Local Institution - 0023
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Local Institution - 0079
Brasília, Federal District, Brazil
Local Institution - 0077
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0076
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0073
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Pio Xii Hosp Cancer De Barretos
Barretos, São Paulo, Brazil
Local Institution - 0075
Rio de Janeiro, , Brazil
Local Institution - 0095
Gatineau, Quebec, Canada
Local Institution - 0138
Montreal, Quebec, Canada
Local Institution - 0017
Montreal, Quebec, Canada
Local Institution - 0052
Trois-Rivières, Quebec, Canada
Local Institution - 0016
Saskatoon, Saskatchewan, Canada
Local Institution - 0161
Beijing, Beijing Municipality, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution - 0156
Beijing, Beijing Municipality, China
Local Institution - 0190
Guangzhou, Guangdong, China
Local Institution - 0192
Changsha, Hunan, China
Local Institution - 0175
Changsha, Hunan, China
Local Institution - 0193
Changsha, Hunan, China
Local Institution - 0179
Nanchang, Jiangxi, China
Local Institution - 0166
Nanchang, Jiangxi, China
Local Institution
Changchun, Jilin, China
Local Institution - 0159
Xi'an, Shan1xi, China
Local Institution - 0180
Xi'an, Shan3xi, China
Local Institution - 0160
Shanghai, Shanghai Municipality, China
Local Institution - 0178
Chengdu, Sichuan, China
Local Institution - 0163
Tianjin, Tianjin Municipality, China
Local Institution - 0189
Hangzhou, Zhejiang, China
Local Institution - 0183
Hangzhou, Zhejiang, China
Local Institution - 0182
Hangzhou, Zhejiang, China
Local Institution - 0165
Shanghai, , China
Local Institution - 0059
Marseille, , France
Local Institution - 0060
Paris, , France
Local Institution - 0112
Paris, , France
Local Institution - 0064
Pierre Benite Cedax, , France
Local Institution - 0061
Rennes, , France
Local Institution - 0113
Strasbourg, , France
Local Institution - 0058
Toulouse, , France
Local Institution - 0062
Tours, , France
Local Institution - 0019
Athens, , Greece
Local Institution - 0122
Thessaloniki, , Greece
Local Institution
Budapest, , Hungary
Local Institution
Székesfehérvár, , Hungary
Local Institution - 0068
Bari, , Italy
Local Institution - 0080
Genova, , Italy
Local Institution - 0070
Perugia, , Italy
Local Institution - 0066
Ravenna, , Italy
Local Institution - 0067
Roma, , Italy
Local Institution - 0131
Nagoya, Aichi-ken, Japan
Local Institution - 0118
Kashiwa-shi, Chiba, Japan
Local Institution - 0111
Kitakyushu-shi, Fukuoka, Japan
Local Institution - 0110
Fukushima, Fukushima, Japan
Local Institution - 0109
Hiroshima, Hiroshima, Japan
Local Institution - 0147
Sapporo, Hokkaido, Japan
Local Institution - 0133
Kobe, Hyōgo, Japan
Local Institution - 0123
Yokohama, Kanagawa, Japan
Local Institution - 0148
Sendai, Miyagi, Japan
Local Institution - 0127
Osaka, Osaka, Japan
Local Institution - 0119
Sakai-shi, Osaka, Japan
Local Institution - 0132
Sunto-gun, Shizuoka, Japan
Local Institution - 0126
Bunkyo-ku, Tokyo, Japan
Local Institution - 0120
Shinjuku-ku, Tokyo, Japan
Local Institution - 0108
Osaka, , Japan
Local Institution - 0124
Tokyo, , Japan
Local Institution - 0050
Craiova, , Romania
Local Institution - 0051
Romania, , Romania
Local Institution - 0069
Sector 2, , Romania
Local Institution - 0097
Busan, , South Korea
Local Institution - 0098
Hwasun, , South Korea
Local Institution - 0105
Seoul, , South Korea
Local Institution - 0028
Barcelona, , Spain
Local Institution - 0029
Madrid, , Spain
Local Institution - 0031
Majadahonda - Madrid, , Spain
Local Institution - 0102
New Taipei City, , Taiwan
Local Institution - 0107
Taichung, , Taiwan
Local Institution - 0099
Taipei, , Taiwan
Local Institution - 0100
Taipei, , Taiwan
Local Institution - 0093
Adana, , Turkey (Türkiye)
Local Institution - 0084
Ankara, , Turkey (Türkiye)
Local Institution - 0115
Istanbul, , Turkey (Türkiye)
Countries
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References
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Forde PM, Spicer JD, Provencio M, Mitsudomi T, Awad MM, Wang C, Lu S, Felip E, Swanson SJ, Brahmer JR, Kerr K, Taube JM, Ciuleanu TE, Tanaka F, Saylors GB, Chen KN, Ito H, Liberman M, Martin C, Broderick S, Wang L, Cai J, Duong Q, Meadows-Shropshire S, Fiore J, Bhatia S, Girard N; CheckMate 816 Investigators. Overall Survival with Neoadjuvant Nivolumab plus Chemotherapy in Lung Cancer. N Engl J Med. 2025 Aug 21;393(8):741-752. doi: 10.1056/NEJMoa2502931. Epub 2025 Jun 2.
Awad MM, Forde PM, Girard N, Spicer J, Wang C, Lu S, Mitsudomi T, Felip E, Broderick SR, Swanson SJ, Brahmer J, Kerr K, Saylors GB, Chen KN, Gharpure V, Neely J, Balli D, Hu N, Provencio Pulla M. Neoadjuvant Nivolumab Plus Ipilimumab Versus Chemotherapy in Resectable Lung Cancer. J Clin Oncol. 2025 Apr 20;43(12):1453-1462. doi: 10.1200/JCO-24-02239. Epub 2025 Jan 8.
Deutsch JS, Cimino-Mathews A, Thompson E, Provencio M, Forde PM, Spicer J, Girard N, Wang D, Anders RA, Gabrielson E, Illei P, Jedrych J, Danilova L, Sunshine J, Kerr KM, Tran M, Bushong J, Cai J, Devas V, Neely J, Balli D, Cottrell TR, Baras AS, Taube JM. Association between pathologic response and survival after neoadjuvant therapy in lung cancer. Nat Med. 2024 Jan;30(1):218-228. doi: 10.1038/s41591-023-02660-6. Epub 2023 Oct 30.
Akinboro O, Drezner N, Amatya A, Runyan J, Fourie-Zirkelbach J, Zhao M, Bi Y, Korsah K, Mixter B, Tang S, Larkins E, Pazdur R, Beaver JA, Singh H. US Food and Drug Administration Approval Summary: Nivolumab Plus Platinum-Doublet Chemotherapy for the Neoadjuvant Treatment of Patients With Resectable Non-Small-Cell Lung Cancer. J Clin Oncol. 2023 Jun 10;41(17):3249-3259. doi: 10.1200/JCO.22.02509. Epub 2023 May 4.
Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N. Plain language summary of the CheckMate 816 study results: nivolumab plus chemotherapy given before surgery for non-small-cell lung cancer. Future Oncol. 2023 Mar;19(8):549-557. doi: 10.2217/fon-2023-0007. Epub 2023 Feb 23.
Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2016-003536-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-816
Identifier Type: -
Identifier Source: org_study_id
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