A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer
NCT ID: NCT04025879
Last Updated: 2025-10-16
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
461 participants
INTERVENTIONAL
2019-11-05
2027-07-30
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
DOUBLE
Study Groups
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Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
Nivolumab
Specified dose on specified days
Carboplatin
Specified dose on specified days
Cisplatin
Specified dose on specified days
Paclitaxel
Specified dose on specified days
Pemetrexed
Specified dose on specified days
Docetaxel
Specified dose on specified days
Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.
Carboplatin
Specified dose on specified days
Cisplatin
Specified dose on specified days
Paclitaxel
Specified dose on specified days
Pemetrexed
Specified dose on specified days
Placebo
Specified dose on specified days
Docetaxel
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Carboplatin
Specified dose on specified days
Cisplatin
Specified dose on specified days
Paclitaxel
Specified dose on specified days
Pemetrexed
Specified dose on specified days
Placebo
Specified dose on specified days
Docetaxel
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No brain metastasis
* Treatment-naive for NSCLC (no prior systemic anti-cancer treatment)
* Ability to provide surgical or biopsy tumor tissue for biomarkers
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
Exclusion Criteria
* Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV)
* Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy for NSCLC
* Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
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 - 0104
Tampa, Florida, United States
Local Institution - 0040
Atlanta, Georgia, United States
Local Institution - 0120
Augusta, Georgia, United States
Local Institution - 0145
Chicago, Illinois, United States
Local Institution - 0078
Chicago, Illinois, United States
Local Institution - 0121
Orland Park, Illinois, United States
Rcca Md Llc
Bethesda, Maryland, United States
Local Institution - 0076
Boston, Massachusetts, United States
Local Institution - 0074
Newton, Massachusetts, United States
Local Institution - 0086
Traverse City, Michigan, United States
Local Institution - 0100
Lebanon, New Hampshire, United States
Local Institution - 0055
Cincinnati, Ohio, United States
Local Institution - 0102
Cleveland, Ohio, United States
Local Institution - 0054
Houston, Texas, United States
Local Institution - 0103
Fredericksburg, Virginia, United States
Local Institution - 0032
Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina
Local Institution - 0031
ABB, Buenos Aires F.D., Argentina
Local Institution - 0043
Buenos Aires, , Argentina
Local Institution - 0030
CABA, , Argentina
Local Institution - 0020
Sydney, New South Wales, Australia
Local Institution - 0033
Heidelberg, Victoria, Australia
Local Institution - 0122
Melbourne, Victoria, Australia
Local Institution - 0023
North Ballarat, Victoria, Australia
Local Institution - 0002
Edegem, , Belgium
Local Institution - 0005
Liège, , Belgium
Local Institution - 0001
Roeselare, , Belgium
Local Institution - 0035
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0029
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0036
São Paulo, São Paulo, Brazil
Local Institution - 0034
São Paulo, São Paulo, Brazil
Local Institution - 0106
São Paulo, , Brazil
Local Institution - 0062
Oshawa, Ontario, Canada
Local Institution - 0115
Beijing, Beijing Municipality, China
Local Institution - 0096
Beijing, BEI, China
Local Institution - 0137
Fuzhou, Fujian, China
Local Institution - 0136
Fuzhou, Fujian, China
Local Institution - 0151
Hubei Sheng, Hubei, China
Local Institution - 0092
Changsha, Hunan, China
Local Institution - 0093
Changsha, Hunan, China
Local Institution - 0091
Changsha, Hunan, China
Local Institution - 0098
Shanghai, Shanghai Municipality, China
Local Institution - 0165
Shanghai, Shanghai Municipality, China
Local Institution - 0113
Shanghai, Shanghai Municipality, China
Local Institution - 0088
Chengdu, Sichuan, China
Local Institution - 0099
Hangzhou, Zhejiang, China
Local Institution - 0095
Shanghai, , China
Local Institution - 0041
Prague, , Czechia
Local Institution - 0042
Prague, , Czechia
Local Institution - 0073
Besançon, , France
Local Institution - 0037
La Tronche, , France
Local Institution - 0050
Montpellier, , France
Local Institution - 0038
Paris, , France
Local Institution - 0051
Paris, , France
Local Institution - 0083
Rennes, , France
Local Institution - 0146
Rouen, , France
Local Institution - 0109
Immenstadt im Allgäu, Bavaria, Germany
Local Institution - 0110
Cologne, North Rhine-Westphalia, Germany
Local Institution - 0085
Berlin, , Germany
Local Institution - 0065
Frankfurt, , Germany
Local Institution - 0072
Georgsmarienhütte, , Germany
Local Institution - 0071
Hamm, , Germany
Local Institution - 0108
Heidelberg, , Germany
Local Institution - 0064
Löwenstein, , Germany
Local Institution - 0147
Ludwigsburg, , Germany
Local Institution - 0063
Lübeck, , Germany
Local Institution - 0070
Moers, , Germany
Local Institution - 0066
München, , Germany
Local Institution - 0016
Dublin, , Ireland
Local Institution - 0024
Forlì, , Italy
Local Institution - 0026
Milan, , Italy
Local Institution - 0025
Parma, , Italy
Local Institution - 0135
Nagoya, Aichi-ken, Japan
Local Institution - 0124
Kashiwa-shi, Chiba, Japan
Local Institution - 0129
Kitakyushu-shi, Fukuoka, Japan
Local Institution - 0127
Kobe, Hyōgo, Japan
Local Institution - 0144
Kanazawa, Ishikawa-ken, Japan
Local Institution - 0125
Yokohama, Kanagawa, Japan
Local Institution - 0131
Sendai, Miyagi, Japan
Local Institution - 0126
Sakai-shi, Osaka, Japan
Local Institution - 0130
Kitaadachigun, Saitama, Japan
Local Institution - 0142
Bunkyo-ku, Tokyo, Japan
Local Institution - 0133
Bunkyo-ku, Tokyo, Japan
Local Institution - 0143
Chuo-ku, Tokyo, Japan
Local Institution - 0134
Chuo-ku, Tokyo, Japan
Local Institution - 0132
Fukushima, , Japan
Local Institution - 0128
Hiroshima, , Japan
Local Institution - 0077
Guadalajara, Jalisco, Mexico
Local Institution - 0027
Monterrey, Nuevo León, Mexico
Local Institution - 0028
Chihuahua City, , Mexico
Local Institution - 0004
Groningen, , Netherlands
Local Institution - 0003
Rotterdam, , Netherlands
Local Institution - 0049
Krakow, Lesser Poland Voivodeship, Poland
Local Institution - 0117
Hato Rey, , Puerto Rico
Local Institution - 0013
Cluj-Napoca, Cluj, Romania
Local Institution - 0011
Bucharest, , Romania
Local Institution - 0012
Floreşti, , Romania
Local Institution
Moscow, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution - 0046
Madrid, , Spain
Local Institution - 0044
Majadahonda - Madrid, , Spain
Local Institution - 0045
Valencia, , Spain
Local Institution - 0149
Kaohsiung City, , Taiwan
Local Institution - 0119
Kaohsiung City, , Taiwan
Local Institution - 0116
New Taipei City, , Taiwan
Local Institution - 0112
Taipei, , Taiwan
Local Institution - 0007
Taunton, , United Kingdom
Countries
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References
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Cascone T, Awad MM, Spicer JD, He J, Lu S, Sepesi B, Tanaka F, Taube JM, Cornelissen R, Havel L, Karaseva N, Kuzdzal J, Petruzelka LB, Wu L, Pujol JL, Ito H, Ciuleanu TE, de Oliveira Muniz Koch L, Janssens A, Alexandru A, Bohnet S, Moiseyenko FV, Gao Y, Watanabe Y, Coronado Erdmann C, Sathyanarayana P, Meadows-Shropshire S, Blum SI, Provencio Pulla M; CheckMate 77T Investigators. Perioperative Nivolumab in Resectable Lung Cancer. N Engl J Med. 2024 May 16;390(19):1756-1769. doi: 10.1056/NEJMoa2311926.
Leal TA, Ramalingam SS. Neoadjuvant therapy gains FDA approval in non-small cell lung cancer. Cell Rep Med. 2022 Jul 19;3(7):100691. doi: 10.1016/j.xcrm.2022.100691.
Hong WX, Sagiv-Barfi I, Czerwinski DK, Sallets A, Levy R. Neoadjuvant Intratumoral Immunotherapy with TLR9 Activation and Anti-OX40 Antibody Eradicates Metastatic Cancer. Cancer Res. 2022 Apr 1;82(7):1396-1408. doi: 10.1158/0008-5472.CAN-21-1382.
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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2019-000262-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-77T
Identifier Type: -
Identifier Source: org_study_id
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