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 recruitment status First Posted Last update posted
NCT04025879 Recruiting July 19, 2019 November 23, 2021

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
Intervention Model : Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Resection and Adjuvant Treatment With Nivolumab or Placebo for Participants With Resectable Stage II-IIIB 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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: 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 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 Fundacao Antonio Prudente-Hospital Ac Camargo Sao Paulo
Brazil Hospital Israelita 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 Changsha
China, Hunan Local Institution Changsha
China, Hunan Local Institution 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 Pneumologicka klinika 1. LF a TN 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 Rouen
Germany Campus Virchow Klinikum Der Charite Berlin
Germany Krankenhaus Nordwest GmbH Frankfurt
Germany MVZ II der Niels Stensen Kliniken Georgsmarienhuette
Germany Evangelisches Krankenhaus Hamm Hamm
Germany Thoraxklinik-Heidelberg gGmbH Heidelberg
Germany Klinikverbund Allgaeu gGmbH Immenstadt
Germany Kliniken Der Stadt Koeln Ggmbh Krankenhaus Mehrheim Koeln
Germany Klinik Löwenstein gGmbH Loewenstein
Germany Klinikum Ludwigsburg Ludwigsburg
Germany Universitaetsklinikum Schleswig-Holstein Luebeck
Germany Krankenhaus Bethanien Moers Moers
Germany Klinikum rechts der Isar der TU 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 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 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 Bucuresti
Romania Local Institution Cluj-Napoca
Romania Local Institution 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 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
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Bristol-Myers Squibb
ClinicalTrials.gov Identifier : NCT04025879     
Other Study ID Numbers : CA209-77T, 2019-000262-38
First Posted : July 19, 2019
Last Update Posted : November 23, 2021
Last Verified : November 2021
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