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.
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
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There are 123 Locations for this study
Fresno California, 93703, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30342, United States
Augusta Georgia, 30912, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Orland Park Illinois, 60462, United States
Westwood Kansas, 66205, United States
Bethesda Maryland, 20817, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Traverse City Michigan, 49684, United States
Lebanon New Hampshire, 03756, United States
Cincinnati Ohio, 45220, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44106, United States
Philadelphia Pennsylvania, 19107, United States
Houston Texas, 77030, United States
Fredericksburg Virginia, 22408, United States
Ciudad Autonoma Beunos Aires Buenos Aires, 1431, Argentina
Buenos Aires , CP128, Argentina
Caba , 1199, Argentina
Caba , 1426, Argentina
Sydney New South Wales, 2050, Australia
Greenslopes Queensland, 4120, Australia
Heidelberg Victoria, 3084, Australia
Melbourne Victoria, 3065, Australia
North Ballarat Victoria, 33500, Australia
Edegem , 2650, Belgium
Liege , 4000, Belgium
Roeselare , 8800, Belgium
Fortaleza Ceara, 60430, Brazil
Belo Horizonte Minas Gerais, 30130, Brazil
Ijui RIO Grande DO SUL, 98700, Brazil
São Paulo SAO Paulo, 01321, Brazil
São Paulo SAO Paulo, 05652, Brazil
Sao Paulo , 01509, Brazil
Oshawa Ontario, L1G 2, Canada
Windsor Ontario, N8W 2, Canada
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H2L 4, Canada
Montreal Quebec, H2X 0, Canada
Praha 2 , 128 0, Czechia
Praha 4 , 140 5, Czechia
Besancon , 25030, France
La Tronche , 38700, France
Montpellier , 34295, France
Paris Cedex 18 , 75018, France
Paris Cedex 20 , 75970, France
Rennes Cedex 9 , 35033, France
Rouen , 76000, France
Berlin , 13353, Germany
Cologne , 51109, Germany
Frankfurt , 60488, Germany
Georgsmarienhuette , 49124, Germany
Hamm , 59063, Germany
Heidelberg , 69126, Germany
Immenstadt , 87509, Germany
Loewenstein , 74245, Germany
Ludwigsburg , 71640, Germany
Luebeck , 23538, Germany
Moers , 47441, Germany
Muenchen , 81675, Germany
Dublin 7 Dublin, , Ireland
Dublin , D24 D, Ireland
Forlì , 47014, Italy
Milano , 20122, Italy
Parma , 43126, Italy
Nagoya-shi Aichi, 46400, Japan
Kashiwa-shi Chiba, 27785, Japan
Kitakyushu-shi Fukuoka, 80785, Japan
Kobe-shi Hyogo, 65000, Japan
Kanazawa-shi Ishikawa, 92086, Japan
Yokohama Kanagawa, 241-8, Japan
Sendai-shi Miyagi, 98008, Japan
Sakai-shi Osaka, 59185, Japan
Kitaadachigun Saitama, 36208, Japan
Bunkyo-ku Tokyo, 11384, Japan
Bunkyo-ku Tokyo, 11386, Japan
Chuo-ku Tokyo, 10400, Japan
Chuo-ku Tokyo, 54185, Japan
Fukushima-shi , 960-1, Japan
Hiroshima , 734-8, Japan
Guadalajara Jalisco, 44280, Mexico
Monterrey Nuevo Leon, 64460, Mexico
Chihuahua , 31000, Mexico
Groningen , 9700R, Netherlands
Rotterdam , 3015 , Netherlands
Kraków Małopolskie, 31-20, Poland
Hato Rey , 00917, Puerto Rico
San Juan , 917, Puerto Rico
Cluj-Napoca Cluj, 40001, Romania
Bucuresti , 02232, Romania
Floresti , 40728, Romania
Krasnodar , 35008, Russian Federation
Moscow , 11547, Russian Federation
Saint-Petersburg , 19775, Russian Federation
St. Petersburg , 19429, Russian Federation
St. Petersburg , 19825, Russian Federation
Madrid , 28006, Spain
Majadahonda - Madrid , 28222, Spain
Valencia , 46026, Spain
Ipswich Suffolk, IP4 5, United Kingdom
Exeter , EX2 5, United Kingdom
Guildford , GU2 7, United Kingdom
Taunton , TA1 5, United Kingdom
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