NCT04025879
Recruiting
July 19, 2019
May 2, 2022
Brief 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.
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo |
Biological: Nivolumab Specified dose on specified days Drug: Carboplatin Specified dose on specified days Drug: Cisplatin Specified dose on specified days Drug: Paclitaxel Specified dose on specified days Drug: Pemetrexed Specified dose on specified days Drug: Docetaxel Specified dose on specified days |
Placebo Comparator: Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac. |
Drug: Carboplatin Specified dose on specified days Drug: Cisplatin Specified dose on specified days Drug: Paclitaxel Specified dose on specified days Drug: Pemetrexed Specified dose on specified days Drug: Placebo Specified dose on specified days Drug: Docetaxel Specified dose on specified days |
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
Contact: BMS Study Connect Contact Center http://www.bmsstudyconnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
United States, California
Local Institution
Fresno
United States, Florida
H. Lee Moffitt Cancer Center
Tampa
United States, Georgia
Northside Hospital
Atlanta
United States, Georgia
Augusta University
Augusta
United States, Illinois
Northwestern University
Chicago
United States, Illinois
University Of Illinois At Chicago
Chicago
United States, Illinois
University of Chicago Medical Center
Orland Park
United States, Kansas
Local Institution
Westwood
United States, Maryland
Rcca Md Llc
Bethesda
United States, Massachusetts
Dana Farber Cancer Institute
Boston
United States, Massachusetts
Massachusetts General Hospital
Boston
United States, Michigan
Munson Medical Center
Traverse City
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon
United States, Ohio
Good Samaritan Hospital
Cincinnati
United States, Ohio
Local Institution
Cincinnati
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland
United States, Pennsylvania
Local Institution
Philadelphia
United States, Texas
The University of Texas MD Anderson Cancer Center-merge
Houston
United States, Virginia
Hematology-Oncology Associates Of Fredricksburg, Inc
Fredericksburg
Argentina, Buenos Aires
Local Institution - 0032
Ciudad Autonoma Beunos Aires
Argentina, Buenos Aires
Hospital Britanico De Buenos Aires
Ciudad Autónoma de Buenos Aires
Argentina
Hospital Italiano De Buenos Aires
Caba
Argentina
Instituto Medico Especialazado Alexander Fleming
Caba
Australia, New South Wales
Chris O'Brien Lifehouse Hospital
Sydney
Australia, Queensland
Local Institution
Greenslopes
Australia, Victoria
Austin Hospital
Heidelberg
Australia, Victoria
St Vincent's Hospital
Melbourne
Australia, Victoria
Ballarat Base Hospital
North Ballarat
Belgium
Local Institution
Edegem
Belgium
Local Institution
Liege
Belgium
Local Institution
Roeselare
Brazil, Ceara
Local Institution
Fortaleza
Brazil, Minas Gerais
PERSONAL Oncologia de Precisao e Personalizada
Belo Horizonte
Brazil, RIO Grande DO SUL
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijui
Brazil, SAO Paulo
Real E Benemerita Associacao Portuguesa De Beneficencia
São Paulo
Brazil
Local Institution - 0036
Sao Paulo
Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Sao Paulo
Canada, Ontario
Local Institution
Oshawa
Canada, Ontario
Local Institution
Windsor
Canada, Quebec
Local Institution
Greenfield Park
Canada, Quebec
Local Institution
Montreal
Canada, Quebec
Local Institution
Montreal
Canada, Quebec
Local Institution
Montreal
China, Beijing
Local Institution
Beijing
China, BEI
Local Institution
Beijing
China, Fujian
Local Institution
Fuzhou
China, Fujian
Local Institution
Fuzhou
China, Hubei
Local Institution
Hubei Sheng
China, Hunan
Local Institution - 0093
Changsha
China, Hunan
Local Institution
Changsha
China, Hunan
Local Institution - 0091
Changsha
China, Jilin
Local Institution
Changchun
China, Shanghai
Local Institution
Shanghai
China, Shanghai
Local Institution
Shanghai
China, Sichuan
Local Institution
Chengdu
China, Zhejiang
Local Institution
Hangzhou
China
Local Institution
Shanghai
Czechia
Onkologicka klinika VFN a 1. LF UK
Praha 2
Czechia
Local Institution - 0042
Praha 4
France
Chu Jean Minjoz
Besancon
France
Local Institution
La Tronche
France
Local Institution
Montpellier
France
Local Institution
Paris Cedex 18
France
Local Institution
Paris Cedex 20
France
Local Institution
Rennes Cedex 9
France
Local Institution - 0146
Rouen
Germany
Local Institution - 0085
Berlin
Germany
Local Institution - 0065
Frankfurt
Germany
Local Institution - 0072
Georgsmarienhuette
Germany
Local Institution - 0071
Hamm
Germany
Local Institution - 0108
Heidelberg
Germany
Local Institution - 0109
Immenstadt
Germany
Local Institution - 0110
Koeln
Germany
Local Institution - 0064
Loewenstein
Germany
Local Institution - 0147
Ludwigsburg
Germany
Local Institution - 0063
Luebeck
Germany
Local Institution - 0070
Moers
Germany
Local Institution - 0066
Muenchen
Ireland, Dublin
Local Institution
Dublin 7
Ireland
Local Institution
Dublin
Italy
IRST Meldola
Forlì
Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milano
Italy
Local Institution - 0025
Parma
Japan, Aichi
Local Institution
Nagoya-shi
Japan, Chiba
Local Institution
Kashiwa-shi
Japan, Fukuoka
Local Institution
Kitakyushu-shi
Japan, Fukushima
Local Institution
Fukushima-shi
Japan, Hyogo
Local Institution
Kobe-shi
Japan, Ishikawa
Local Institution
Kanazawa-shi
Japan, Kanagawa
Local Institution
Yokohama
Japan, Miyagi
Local Institution
Sendai-shi
Japan, Osaka
Local Institution - 0126
Sakai-shi
Japan, Saitama
Local Institution
Kitaadachigun
Japan, Tokyo
Local Institution
Bunkyo-ku
Japan, Tokyo
Local Institution
Bunkyo-ku
Japan, Tokyo
Local Institution
Chuo-ku
Japan, Tokyo
Local Institution
Chuo-ku
Japan
Local Institution
Hiroshima
Mexico, Jalisco
Hospital Civil De Guadalajara Juan I Menchaca
Guadalajara
Mexico, Nuevo Leon
Hospital Universitario Doctor Jose Eleuterio Gonzalez
Monterrey
Mexico
Centro Estatal de Cancerologia
Chihuahua
Netherlands
Local Institution
Groningen
Netherlands
Local Institution
Rotterdam
Poland
Oddzial Kliniczny Chirurgii Klatki Piersiowej
Krakow
Puerto Rico
Puerto Rico Medical Research Center
Hato Rey
Puerto Rico
Local Institution
San Juan
Romania
Local Institution - 0011
Bucuresti
Romania
Local Institution - 0013
Cluj-Napoca
Romania
Local Institution - 0012
Floresti
Russian Federation
Local Institution
Krasnodar
Russian Federation
Local Institution
Moscow
Russian Federation
Local Institution
Saint-Petersburg
Russian Federation
Local Institution
St. Petersburg
Russian Federation
Local Institution
St. Petersburg
Spain
Local Institution
Barcelona
Spain
Local Institution
L'Hospitalet
Spain
Local Institution
Madrid
Spain
Local Institution - 0044
Majadahonda - Madrid
Spain
Local Institution
Valencia
Taiwan
Local Institution
Kaohsiung City
Taiwan
Local Institution
Kaohsiung
Taiwan
Local Institution
New Taipei City
Taiwan
Local Institution
Taipei City
United Kingdom, Suffolk
Local Institution
Ipswich
United Kingdom
Local Institution
Exeter
United Kingdom
Local Institution
Guildford
United Kingdom
Local Institution
Taunton
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb