Lung Cancer Clinical Trial

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

Summary

The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants with suspected or histologically confirmed Stage IIA (> 4 cm) to IIIB (T3N2) non-small cell lung carcinoma (NSCLC) with disease that is considered resectable
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:

Participants with an active, known or suspected autoimmune disease
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

Other protocol-defined inclusion/exclusion criteria apply

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

452

Study ID:

NCT04025879

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 123 Locations for this study

See Locations Near You

Local Institution
Fresno California, 93703, United States
Local Institution - 0104
Tampa Florida, 33612, United States
Local Institution - 0040
Atlanta Georgia, 30342, United States
Local Institution - 0120
Augusta Georgia, 30912, United States
Local Institution - 0145
Chicago Illinois, 60611, United States
Local Institution - 0078
Chicago Illinois, 60612, United States
Local Institution - 0121
Orland Park Illinois, 60462, United States
Local Institution
Westwood Kansas, 66205, United States
Rcca Md Llc
Bethesda Maryland, 20817, United States
Local Institution - 0074
Boston Massachusetts, 02215, United States
Local Institution - 0076
Boston Massachusetts, 02215, United States
Munson Medical Center
Traverse City Michigan, 49684, United States
Local Institution - 0100
Lebanon New Hampshire, 03756, United States
Local Institution - 0055
Cincinnati Ohio, 45220, United States
Local Institution
Cincinnati Ohio, 45267, United States
Local Institution - 0102
Cleveland Ohio, 44106, United States
Thomas Jefferson University - Clinical Trials Office-Medical Oncology
Philadelphia Pennsylvania, 19107, United States
Local Institution - 0054
Houston Texas, 77030, United States
Local Institution - 0103
Fredericksburg Virginia, 22408, United States
Local Institution - 0032
Ciudad Autonoma Beunos Aires Buenos Aires, 1431, Argentina
Local Institution - 0043
Buenos Aires , CP128, Argentina
Local Institution - 0031
Caba , 1199, Argentina
Local Institution - 0030
Caba , 1426, Argentina
Local Institution - 0020
Sydney New South Wales, 2050, Australia
Local Institution
Greenslopes Queensland, 4120, Australia
Local Institution - 0033
Heidelberg Victoria, 3084, Australia
St Vincent's Hospital
Melbourne Victoria, 3065, Australia
Local Institution - 0023
North Ballarat Victoria, 33500, Australia
Local Institution - 0002
Edegem , 2650, Belgium
Local Institution - 0005
Liege , 4000, Belgium
Local Institution - 0001
Roeselare , 8800, Belgium
Local Institution
Fortaleza Ceara, 60430, Brazil
Local Institution - 0035
Belo Horizonte Minas Gerais, 30130, Brazil
Local Institution - 0029
Ijui RIO Grande DO SUL, 98700, Brazil
Local Institution - 0106
São Paulo SAO Paulo, 01321, Brazil
Local Institution - 0034
São Paulo SAO Paulo, 05652, Brazil
Local Institution - 0036
Sao Paulo , 01509, Brazil
Local Institution - 0062
Oshawa Ontario, L1G 2, Canada
Local Institution
Windsor Ontario, N8W 2, Canada
Local Institution
Greenfield Park Quebec, J4V 2, Canada
Local Institution
Montreal Quebec, H2L 4, Canada
Local Institution
Montreal Quebec, H2X 0, Canada
Local Institution
Montreal Quebec, H3T 1, Canada More Info
Site 0123
Contact
Local Institution - 0115
Beijing Beijing, 10002, China More Info
Site 0115
Contact
Local Institution
Beijing BEI, 10014, China More Info
Site 0096
Contact
Local Institution - 0137
Fuzhou Fujian, 35000, China More Info
Site 0137
Contact
Local Institution - 0136
Fuzhou Fujian, 35001, China More Info
Site 0136
Contact
Local Institution - 0151
Hubei Sheng Hubei, 43007, China More Info
Site 0151
Contact
Local Institution - 0092
Changsha Hunan, 41000, China More Info
Site 0092
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Local Institution - 0093
Changsha Hunan, 41000, China More Info
Site 0093
Contact
Local Institution - 0091
Changsha Hunan, 41000, China More Info
Site 0091
Contact
Local Institution - 0152
Changchun Jilin, 13002, China More Info
Site 0152
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Local Institution - 0098
Shanghai Shanghai, 20001, China More Info
Site 0098
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Local Institution - 0165
Shanghai Shanghai, 20003, China More Info
Site 0165
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Local Institution - 0113
Shanghai Shanghai, 20043, China More Info
Site 0113
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Local Institution - 0088
Chengdu Sichuan, 61004, China More Info
Site 0088
Contact
Local Institution - 0099
Hangzhou Zhejiang, 31001, China More Info
Site 0099
Contact
Local Institution - 0095
Shanghai , 20003, China More Info
Site 0095
Contact
Local Institution - 0041
Praha 2 , 128 0, Czechia
Local Institution - 0042
Praha 4 , 140 5, Czechia
Chu Jean Minjoz
Besancon , 25030, France
Local Institution - 0037
La Tronche , 38700, France
Local Institution - 0050
Montpellier , 34295, France
Local Institution
Paris Cedex 18 , 75018, France
Local Institution - 0051
Paris Cedex 20 , 75970, France
Local Institution - 0083
Rennes Cedex 9 , 35033, France
Local Institution - 0146
Rouen , 76000, France
Local Institution - 0085
Berlin , 13353, Germany
Local Institution - 0110
Cologne , 51109, Germany
Local Institution - 0065
Frankfurt , 60488, Germany
Local Institution - 0072
Georgsmarienhuette , 49124, Germany
Local Institution - 0071
Hamm , 59063, Germany
Local Institution - 0108
Heidelberg , 69126, Germany
Local Institution - 0109
Immenstadt , 87509, Germany
Local Institution - 0064
Loewenstein , 74245, Germany
Local Institution - 0147
Ludwigsburg , 71640, Germany
Local Institution - 0063
Luebeck , 23538, Germany
Local Institution - 0070
Moers , 47441, Germany
Local Institution - 0066
Muenchen , 81675, Germany
Local Institution
Dublin 7 Dublin, , Ireland
Local Institution - 0016
Dublin , D24 D, Ireland
IRST Meldola
Forlì , 47014, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milano , 20122, Italy
Azienda Ospedaliera Di Parma
Parma , 43126, Italy
Local Institution - 0135
Nagoya-shi Aichi, 46400, Japan
Local Institution - 0124
Kashiwa-shi Chiba, 27785, Japan
Local Institution - 0129
Kitakyushu-shi Fukuoka, 80785, Japan
Local Institution - 0127
Kobe-shi Hyogo, 65000, Japan
Local Institution - 0144
Kanazawa-shi Ishikawa, 92086, Japan
Local Institution - 0125
Yokohama Kanagawa, 241-8, Japan
Local Institution - 0131
Sendai-shi Miyagi, 98008, Japan
Local Institution - 0126
Sakai-shi Osaka, 59185, Japan
Local Institution - 0130
Kitaadachigun Saitama, 36208, Japan
Local Institution - 0142
Bunkyo-ku Tokyo, 11384, Japan
Local Institution - 0133
Bunkyo-ku Tokyo, 11386, Japan
Local Institution - 0143
Chuo-ku Tokyo, 10400, Japan
Local Institution - 0134
Chuo-ku Tokyo, 54185, Japan
Local Institution - 0132
Fukushima-shi , 960-1, Japan
Local Institution - 0128
Hiroshima , 734-8, Japan
Local Institution - 0077
Guadalajara Jalisco, 44280, Mexico
Local Institution - 0027
Monterrey Nuevo Leon, 64460, Mexico
Local Institution - 0028
Chihuahua , 31000, Mexico
Local Institution - 0004
Groningen , 9700R, Netherlands
Local Institution - 0003
Rotterdam , 3015 , Netherlands
Local Institution - 0049
Kraków Małopolskie, 31-20, Poland
Local Institution - 0117
Hato Rey , 00917, Puerto Rico
Local Institution
San Juan , 917, Puerto Rico
Local Institution - 0013
Cluj-Napoca Cluj, 40001, Romania
Local Institution - 0011
Bucuresti , 02232, Romania
Local Institution - 0012
Floresti , 40728, Romania
Local Institution
Krasnodar , 35008, Russian Federation
Local Institution
Moscow , 11547, Russian Federation
Local Institution
Saint-Petersburg , 19775, Russian Federation
Local Institution
St. Petersburg , 19429, Russian Federation
Local Institution
St. Petersburg , 19825, Russian Federation
Local Institution
Barcelona , 08035, Spain More Info
Site 0159
Contact
Local Institution
L'Hospitalet , 08907, Spain More Info
Site 0158
Contact
Local Institution - 0046
Madrid , 28006, Spain
Local Institution - 0044
Majadahonda - Madrid , 28222, Spain
Local Institution - 0045
Valencia , 46026, Spain
Local Institution
Kaohsiung City , 807, Taiwan More Info
Site 0149
Contact
Local Institution - 0119
Kaohsiung , 833, Taiwan More Info
Site 0119
Contact
Local Institution - 0116
New Taipei City , 235, Taiwan More Info
Site 0116
Contact
Local Institution - 0112
Taipei City , 10022, Taiwan More Info
Site 0112
Contact
Local Institution
Ipswich Suffolk, IP4 5, United Kingdom
Local Institution
Exeter , EX2 5, United Kingdom
Local Institution
Guildford , GU2 7, United Kingdom
Local Institution - 0007
Taunton , TA1 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

452

Study ID:

NCT04025879

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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