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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

    September 14, 2022

Save Trial
Clinical Trial Information for Patients Visit BMS Study Connect

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: Drug: Pemetrexed
    Drug: Placebo
    Drug: Docetaxel
    Drug: Cisplatin
    Drug: Paclitaxel
    Biological: Nivolumab
    Drug: Carboplatin
  • 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
Local Institution - 0104
Tampa

United States, Georgia
Local Institution - 0040
Atlanta

United States, Georgia
Local Institution - 0120
Augusta

United States, Illinois
Local Institution - 0145
Chicago

United States, Illinois
Local Institution - 0078
Chicago

United States, Illinois
Local Institution - 0121
Orland Park

United States, Kansas
Local Institution
Westwood

United States, Maryland
Rcca Md Llc
Bethesda

United States, Massachusetts
Local Institution - 0074
Boston

United States, Massachusetts
Local Institution - 0076
Boston

United States, Michigan
Munson Medical Center
Traverse City

United States, New Hampshire
Local Institution - 0100
Lebanon

United States, Ohio
Local Institution - 0055
Cincinnati

United States, Ohio
Local Institution
Cincinnati

United States, Ohio
Local Institution - 0102
Cleveland

United States, Pennsylvania
Thomas Jefferson University - Clinical Trials Office-Medical Oncology
Philadelphia

United States, Texas
Local Institution - 0054
Houston

United States, Virginia
Local Institution - 0103
Fredericksburg

Argentina, Buenos Aires
Local Institution - 0032
Ciudad Autonoma Beunos Aires

Argentina
Local Institution - 0043
Buenos Aires

Argentina
Local Institution - 0031
Caba

Argentina
Local Institution - 0030
Caba

Australia, New South Wales
Local Institution - 0020
Sydney

Australia, Queensland
Local Institution
Greenslopes

Australia, Victoria
Local Institution - 0033
Heidelberg

Australia, Victoria
St Vincent's Hospital
Melbourne

Australia, Victoria
Local Institution - 0023
North Ballarat

Belgium
Local Institution - 0002
Edegem

Belgium
Local Institution - 0005
Liege

Belgium
Local Institution - 0001
Roeselare

Brazil, Ceara
Local Institution
Fortaleza

Brazil, Minas Gerais
Local Institution - 0035
Belo Horizonte

Brazil, RIO Grande DO SUL
Local Institution - 0029
Ijui

Brazil, SAO Paulo
Local Institution - 0106
São Paulo

Brazil, SAO Paulo
Local Institution - 0034
São Paulo

Brazil
Local Institution - 0036
Sao Paulo

Canada, Ontario
Local Institution - 0062
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 - 0115
Beijing

China, BEI
Local Institution
Beijing

China, Fujian
Local Institution - 0137
Fuzhou

China, Fujian
Local Institution - 0136
Fuzhou

China, Hubei
Local Institution - 0151
Hubei Sheng

China, Hunan
Local Institution - 0092
Changsha

China, Hunan
Local Institution - 0093
Changsha

China, Hunan
Local Institution - 0091
Changsha

China, Jilin
Local Institution - 0152
Changchun

China, Shanghai
Local Institution - 0098
Shanghai

China, Shanghai
Local Institution - 0165
Shanghai

China, Shanghai
Local Institution - 0113
Shanghai

China, Sichuan
Local Institution - 0088
Chengdu

China, Zhejiang
Local Institution - 0099
Hangzhou

China
Local Institution - 0095
Shanghai

Czechia
Local Institution - 0041
Praha 2

Czechia
Local Institution - 0042
Praha 4

France
Chu Jean Minjoz
Besancon

France
Local Institution - 0037
La Tronche

France
Local Institution - 0050
Montpellier

France
Local Institution
Paris Cedex 18

France
Local Institution - 0051
Paris Cedex 20

France
Local Institution - 0083
Rennes Cedex 9

France
Local Institution - 0146
Rouen

Germany
Local Institution - 0085
Berlin

Germany
Local Institution - 0110
Cologne

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 - 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 - 0016
Dublin

Italy
IRST Meldola
Forlì

Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milano

Italy
Azienda Ospedaliera Di Parma
Parma

Japan, Aichi
Local Institution - 0135
Nagoya-shi

Japan, Chiba
Local Institution - 0124
Kashiwa-shi

Japan, Fukuoka
Local Institution - 0129
Kitakyushu-shi

Japan, Hyogo
Local Institution - 0127
Kobe-shi

Japan, Ishikawa
Local Institution - 0144
Kanazawa-shi

Japan, Kanagawa
Local Institution - 0125
Yokohama

Japan, Miyagi
Local Institution - 0131
Sendai-shi

Japan, Osaka
Local Institution - 0126
Sakai-shi

Japan, Saitama
Local Institution - 0130
Kitaadachigun

Japan, Tokyo
Local Institution - 0142
Bunkyo-ku

Japan, Tokyo
Local Institution - 0133
Bunkyo-ku

Japan, Tokyo
Local Institution - 0143
Chuo-ku

Japan, Tokyo
Local Institution - 0134
Chuo-ku

Japan
Local Institution - 0132
Fukushima-shi

Japan
Local Institution - 0128
Hiroshima

Mexico, Jalisco
Local Institution - 0077
Guadalajara

Mexico, Nuevo Leon
Local Institution - 0027
Monterrey

Mexico
Local Institution - 0028
Chihuahua

Netherlands
Local Institution - 0004
Groningen

Netherlands
Local Institution - 0003
Rotterdam

Poland, Małopolskie
Local Institution - 0049
Kraków

Puerto Rico
Local Institution - 0117
Hato Rey

Puerto Rico
Local Institution
San Juan

Romania, Cluj
Local Institution - 0013
Cluj-Napoca

Romania
Local Institution - 0011
Bucuresti

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 - 0046
Madrid

Spain
Local Institution - 0044
Majadahonda - Madrid

Spain
Local Institution - 0045
Valencia

Taiwan
Local Institution
Kaohsiung City

Taiwan
Local Institution - 0119
Kaohsiung

Taiwan
Local Institution - 0116
New Taipei City

Taiwan
Local Institution - 0112
Taipei City

United Kingdom, Suffolk
Local Institution
Ipswich

United Kingdom
Local Institution
Exeter

United Kingdom
Local Institution
Guildford

United Kingdom
Local Institution - 0007
Taunton

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information