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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

  • Clinicaltrials.gov identifier

    NCT04025879

  • Recruitment Status

    Recruiting

  • First Posted

    July 19, 2019

  • Last update posted

    May 2, 2022

Study Description

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.

  • Condition or Disease:Carcinoma, Non-Small-Cell Lung
  • Intervention/Treatment: Biological: Nivolumab
    Drug: Carboplatin
    Drug: Cisplatin
    Drug: Paclitaxel
    Drug: Pemetrexed
    Drug: Placebo
    Drug: Docetaxel
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 452 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment
  • Official Title: 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
  • Actual Study Start Date: November 2019
  • Estimated Primary Completion Date: December 2023
  • Estimated Study Completion Date: September 2024

Arms and interventions

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

Outcome Measures

  • Primary Outcome Measures: 1. Event-Free Survival (EFS) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: 5 Years from randomization ]
  • Secondary Outcome Measures: 1. Overall Survival (OS) [ Time Frame: Up to 5 years from randomization ]
  • 2. Pathologic Complete Response (pCR) Rate as Assessed by Blinded Independent Pathology Review (BIPR) [ Time Frame: At the time of surgery, between week 12 to week 18 ]
  • 3. Major Pathological Response (MPR) Rate as Assessed by Blinded Independent Pathology Review [ Time Frame: Up to 8 weeks following completion of neoadjuvant surgery, approximately study week 22 ]
  • 4. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 80 weeks ]
  • 5. Incidence of Adverse Events (AEs) [ Time Frame: Up to 80 weeks ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

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 #.

Locations

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

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04025879 History of Changes
  • Other Study ID Numbers: CA209-77T, 2019-000262-38
  • First Posted: July 19, 2019 Key Record Dates
  • Last Update Posted: May 2, 2022
  • Last Verified: April 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung
    Carcinoma, Bronchogenic
    Bronchial Neoplasms
    Lung Neoplasms
    Respiratory Tract Neoplasms
    Thoracic Neoplasms
    Neoplasms by Site
    Neoplasms
    Lung Diseases
    Respiratory Tract Diseases