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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Clinical Trials of Interest

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An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC) (CheckMate 227)

  • Clinicaltrials.gov identifier

    NCT02477826

  • Recruitment Status

    Recruiting

  • First Posted

    June 23, 2015

  • Last update posted

    September 21, 2021

Study Description

Brief summary:

The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.

  • Condition or Disease:Non-Small Cell Lung Cancer
  • Intervention/Treatment: Drug: Nivolumab
    Drug: Ipilimumab
    Drug: Carboplatin
    Drug: Cisplatin
    Drug: Gemcitabine
    Drug: Pemetrexed
    Drug: Paclitaxel
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 1980 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
  • Actual Study Start Date: August 2015
  • Estimated Primary Completion Date: August 2024
  • Estimated Study Completion Date: August 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Arm A: Nivolumab
Nivolumab intravenously (IV) as specified
Drug: Nivolumab
Experimental: Arm B: Nivolumab + Ipilimumab
Nivolumab + Ipilimumab IV as specified
Drug: Nivolumab


Drug: Ipilimumab
Experimental: Arm C: Nivolumab + Platinum doublet chemotherapy
Nivolumab + Platinum doublet chemotherapy (IV) dose as specified
Drug: Nivolumab


Drug: Carboplatin


Drug: Cisplatin


Drug: Gemcitabine


Drug: Pemetrexed


Drug: Paclitaxel
Experimental: Arm D: Platinum doublet chemotherapy
Chemotherapy administered on specified days of IV chemotherapy
Drug: Carboplatin


Drug: Cisplatin


Drug: Gemcitabine


Drug: Pemetrexed


Drug: Paclitaxel

Outcome Measures

  • Primary Outcome Measures: 1. Overall survival (OS) [ Time Frame: approximately 48 months ]
  • 2. Progression-free Survival (PFS) as determined by blinded independent central review (BICR) [ Time Frame: approximately 40 months ]
  • Secondary Outcome Measures: 1. Objective response rate (ORR) [ Time Frame: Up to 48 months ]
    ORR of nivolumab monotherapy and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy in subjects with advanced lung cancer
  • 2. Disease related symptom improvement as measured by the Lung Cancer Symptom Score (LCSS) in all subjects [ Time Frame: Up to 48 months ]
    Disease related symptom improvement assessed at each dosing for 6 months, then every 6 weeks while on treatment

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 BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy - Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period - Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 - Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria Exclusion Criteria: - Subjects with untreated Central nervous system (CNS) metastases are excluded - Subjects with an active, known or suspected autoimmune disease are excluded - Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) indicating acute or chronic infection Other protocol defined inclusion/exclusion criteria could 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, Alabama
Southern Cancer Center, Inc.
Mobile

United States, California
Local Institution
La Jolla

United States, California
California Pacific Medical Center
San Francisco

United States, Connecticut
Yale University
New Haven

United States, Georgia
Emory University Hospital
Atlanta

United States, Georgia
Northwest Georgia Oncology Centers, P.C.
Marietta

United States, Kentucky
Baptist Health Lexington
Lexington

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore

United States, Massachusetts
Local Institution
Boston

United States, Massachusetts
Local Institution
Boston

United States, Michigan
Local Institution
Southfield

United States, Minnesota
Local Institution
Rochester

United States, Missouri
Washington University School Of Medicine
Saint Louis

United States, New York
Roswell Park Cancer Institute
Buffalo

United States, New York
Memorial Sloan Kettering Nassau
New York

United States, North Carolina
Duke University Medical Center
Durham

United States, Ohio
University Hospitals
Cleveland

United States, Ohio
The Ohio State University
Columbus

United States, Pennsylvania
Lehigh Valley Health Network
Allentown

United States, Pennsylvania
St. Mary Medical Center
Langhorne

United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia

United States, Pennsylvania
Thomas Jefferson University
Philadelphia

United States, Pennsylvania
Guthrie Medical Group, Pc
Sayre

United States, South Carolina
Hollings Cancer Center
Charleston

United States, South Carolina
Greenville Health System
Greenville

United States, South Carolina
St Francis Hospital
Greenville

United States, Tennessee
Vanderbilt University Medical Center
Nashville

United States, Texas
The University Of Texas
Dallas

United States, Texas
University Of Texas Southwestern Medical Center
Dallas

United States, Texas
University Of Texas Md Anderson Cancer Ctr
Houston

United States, Utah
Huntsman Cancer Institute At The Univ. Of Utah
Salt Lake City

United States, Washington
Kadlec Clinical Hematology and Oncology
Kennewick

China, Anhui
Local Institution
Hefei

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Chongqing
Local Institution
Chongqing

China, Guangdong
Local Institution
Guangzhou

China, Guangdong
Local Institution
Guangzhou

China, Guangdong
Local Institution
Guanzhou

China, Hainan
Local Institution
Haikou

China, Heilongjiang
Local Institution
Haerbin

China, Henan
Local Institution
Zhengzhou

China, Henan
Local Institution
Zhengzhou

China, Hunan
Local Institution
Changsha

China, Hunan
Local Institution
Changsha

China, Jiangsu
Local Institution
Nanjing

China, Jiangxi
Local Institution
Nanchang

China, Jilin
Local Institution
Changchun

China, Jilin
Local Institution
Changchun

China, Liaoning
Local Institution
Shenyang

China, Shaanxi
Local Institution
Xi'an

China, Shan3xi
Local Institution
Xi'an

China, Shandong
Local Institution
Qingdao

China, Shanghai
Local Institution
Shanghai

China, Shanghai
Local Institution
Shanghai

China, Shanghai
Local Institution
Shanghai

China, Xinjiang
Local Institution
Urumqi

China, Zhejiang
Local Institution
Hanghzou

China, Zhejiang
Local Institution
Hangzhou

China, Zhejiang
Local Institution
Hangzhou

China
Local Institution
Beijing

China
Local Institution
Beijing

China
Local Institution
Chongqing

China
Local Institution
Chongqing

China
Local Institution
Hangzhou

China
Local Institution
Hangzhou

China
Local Institution
Kunming

China
Local Institution
Shanghai

China
Local Institution
Shantou

Argentina, Buenos Aires
COIBA
Berazategui

Argentina, Buenos Aires
Instituto Alexander Fleming
Capital Federal

Argentina, Buenos Aires
Hospital Italiano De Buenos Aires
Ciudad Autonoma De Buenos Aire

Argentina, Buenos Aires
Fundacion Investigar
Ciudad de Buenos Aires

Argentina, Buenos Aires
Hospital Privado De Comunidad
Mar Del Plata

Argentina, Cordoba
Hospital Privado Centro Medico De Cordoba
Córdoba

Argentina, RIO Negro
Clinica Viedma S.A.
Viedma

Argentina, Tucuman
Centro Medico San Roque
San Miguel de Tucuman

Argentina
Local Institution
Caba

Argentina
Instituto Oncologico De Cordoba
Cordoba

Argentina
Clinica Privada Universitaria Reina Fabiola
Cordoba

Australia, Australian Capital Territory
Local Institution
Garran

Australia, New South Wales
Blacktown Hospital
Blacktown

Australia, New South Wales
Local Institution
Gosford

Australia, New South Wales
Tamworth Hospital
Tamworth

Australia, Queensland
Princess Alexandra Hospital
Brisbane

Australia, South Australia
Local Institution
Elizabeth Vale

Australia, Victoria
Local Institution
Clayton

Australia, Victoria
St Vincent's Hospital
Fitzroy

Australia, Western Australia
Local Institution
Perth

Australia
Local Institution
Murdoch

Austria
Medizinische Universitatsklinik
Graz

Austria
Akh Wien
Vienna

Austria
Klinikum Wels-Grieskirchen Gmbh
Wels

Belgium
Local Institution
Charleroi

Belgium
Local Institution
Edegem

Belgium
Local Institution
Gent

Belgium
Local Institution
Hasselt

Belgium
Local Institution
Roeselare

Belgium
Local Institution
Sint Niklaas

Brazil, Bahia
Local Institution
Salvador

Brazil, RIO Grande DO SUL
Local Institution
Ijui

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil, SAO Paulo
Local Institution
Barretos

Brazil
Local Institution
Rio De Janeiro

Brazil
Local Institution
Sao Paulo

Brazil
Local Institution
Sao Paulo

Brazil
Local Institution
Sao Paulo

Canada, Alberta
Cross Cancer Institute
Edmonton

Canada, Newfoundland and Labrador
Dr. H.Bliss Murphy Cancer Centre
St. John's

Canada, Ontario
London Regional Cancer Program
London

Canada, Quebec
Jewish General Hospital
Montreal

Canada, Quebec
CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski
Rimouski

Canada, Quebec
Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS
Sherbrooke

Canada, Quebec
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec
Trois-Rivieres

Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Universite Laval
Quebec

Canada
CHU de Quebec - Universite Laval
Quebec

Chile, Metropolitana
Fundacion Arturo Lopez Perez
Santiago

Chile, Santiago DE Chile
Centro Internacional de Estudios Clinicos
Recoleta

Chile, Valparaiso
Instituto Oncologico
Vina Del Mar

Colombia, Risaralda
Oncologos Del Occidente Sa
Pereira

Colombia
Administradora Del Country S.A. - Clinica Del Country
Bogota

Colombia
Hospital Universitario San Ignacio
Bogota

Colombia
Hospital Pablo Tobon Uribe
Medellin

Czechia
Plicni klinika
Hradec Kralove

Czechia
Klinika plicnich nemoci a tuberkulozy
Olomouc

Czechia
Pneumologicka klinika 1. LF a TN
Praha 4

Czechia
Oddeleni Onkologie
Pribram

Finland
Local Institution
Oulu

Finland
Local Institution
Turku

France
Local Institution
ANGERS Cedex 2

France
Local Institution
Besançon Cedex

France
Local Institution
Bron Cedex

France
Local Institution
Caen

France
Local Institution
Creteil

France
Local Institution
Limoges cedex

France
Hopital Nord
Marseille Cedex 20

France
Local Institution
Paris

France
Local Institution
Pessac

France
Local Institution
Rennes Cedex 9

France
Local Institution
Rouen

France
Local Institution
Saint Herblain

France
Local Institution
Saint Priest En Jarez

France
Local Institution
Strasbourg

France
Local Institution
Toulon

Germany, Thuringen
Zentralklinik Bad Berka Gmbh
Bad Berka

Germany
Local Institution
Berlin

Germany
Universitaetsklinikum Essen
Essen

Germany
Universitatsklinikum Frankfurt
Frankfurt

Germany
SRH WALD KLINIKUM GERA gGmbH
Gera

Germany
Klinik Schillerhoehe
Gerlingen

Germany
Krankenhaus Grosshansdorf
Grosshansdorf

Germany
Stadtisches Krankenhaus Martha Maria Halle-Dolau
Halle

Germany
Thoraxklinik-Heidelberg Ggmbh
Heidelberg

Germany
Lungenklinik Hemer
Hemer

Germany
Klinikverbund Kempten-Oberallgau
Immenstadt

Germany
Universitaetsklinikum Magdeburg A. o. R.
Magdeburg

Germany
Klinikum Bogenhausen
Muenchen

Germany
Hsk Dr.-Horst-Schmidt-Kliniken Wiesbaden
Wiesbaden

Greece
Sotiria General Hospital
Athens

Greece
University Hospital Of Heraklion
Heraklio

Greece
Metropolitan Hospital
Neo Faliro

Greece
Local Institution
Thessaloniki

Hungary
Local Institution
Budapest

Hungary
Local Institution
Budapest

Hungary
Local Institution
Matrahaza

Ireland, Dublin
Local Institution
Dublin 8

Ireland
Local Institution
Dublin

Ireland
Local Institution
Galway

Ireland
Local Institution
Limerick

Israel
Local Institution
Jerusalem

Israel
Local Institution
Kfar-saba

Israel
Local Institution
Petach Tikva

Israel
Local Institution
Tel-hashomer

Israel
Local Institution
Zerifin

Italy
Local Institution
Avellino

Italy
Local Institution
Bergamo

Italy
Local Institution
Bologna

Italy
Local Institution
Livorno

Italy
Local Institution
Messina

Italy
Local Institution
Milano

Italy
Local Institution
Milan

Italy
Local Institution
Napoli

Italy
Ospedale Santa Maria delle Croci
Ravenna

Italy
Local Institution
Roma

Italy
Local Institution
Roma

Italy
Local Institution
S.Andrea Fratte PG

Italy
Ospedale S.Maria
Terni

Japan, Aichi
Local Institution
Nagoya-shi

Japan, Aichi
Local Institution
Nagoya-shi

Japan, Chiba
Local Institution
Chiba-shi

Japan, Chiba
Local Institution
Kashiwa-shi

Japan, Ehime
Local Institution
Matsuyama-shi

Japan, Fukuoka
Local Institution
Fukuoka-shi

Japan, Fukuoka
Local Institution
Kurume-shi

Japan, Gunma
Local Institution
Ota-shi

Japan, Hiroshima
Local Institution
Hiroshima-shi

Japan, Hokkaido
Local Institution
Sapporo-shi

Japan, Hokkaido
Local Institution
Sapporo-shi

Japan, Hyogo
Local Institution
Akashi-shi

Japan, Hyogo
Local Institution
Kobe-shi

Japan, Ishikawa
Local Institution
Kanazawa-shi

Japan, Kanagawa
Local Institution
Yokohama-shi

Japan, Kanagawa
Local Institution
Yokohama-Shi

Japan, Miyagi
Local Institution
Natori-shi

Japan, Miyagi
Local Institution
Sendai-shi

Japan, Miyagi
Local Institution
Sendai-shi

Japan, Niigata
Local Institution
Niigata-shi

Japan, Okayama
Local Institution
Kurashiki-shi

Japan, Okayama
Local Institution
Okayama-shi

Japan, Osaka
Local Institution
Hirakata-shi

Japan, Osaka
Local Institution
Osaka-shi

Japan, Osaka
Local Institution
Osakasayama-shi

Japan, Osaka
Local Institution
Takatsuki-shi

Japan, Saitama
Local Institution
Hidaka-shi

Japan, Saitama
Local Institution
Kitaadachi-gun

Japan, Shizuoka
Local Institution
Sunto-gun

Japan, Tokyo
Local Institution
Bunkyo-ku

Japan, Tokyo
Local Institution
Chuo-ku

Japan, Tokyo
Local Institution
Koto-ku

Japan, Tokyo
Local Institution
Shinjuku-ku

Japan, Wakayama
Local Institution
Wakayama-shi

Japan, Yamaguchi
Local Institution
Ube-shi

Korea, Republic of, Chungcheonbuk-do
Local Institution
Cheongju-si

Korea, Republic of, Gyeonggi-do
Local Institution
Seongnam-si

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Lebanon
Local Institution
Beirut

Lebanon
Local Institution
Beirut

Mexico, Distrito Federal
Local Institution
Df

Mexico, Distrito Federal
Local Institution
Mexico

Mexico, Estado DE Mexico
Phylasis Clinicas Research S de R. L. de C. V.
Cuautitlan

Mexico, Estado DE Mexico
Local Institution
Toluca

Mexico, Jalisco
Instituto Jalisciense De Cancerologia
Guadalajara

Mexico, Michoacan
Local Institution
Morelia

Mexico, Nuevo LEON
Axis Heilsa S de Rl de Cv
Monterrey

Mexico, Yucatan
Medical Care & Research
Merida

Mexico
Local Institution
Chihuahua

Mexico
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
San Luis Potosi

Mexico
Local Institution
San Luis Potosi

Netherlands
Local Institution
Amsterdam

Netherlands
Local Institution
Amsterdam

Netherlands
Local Institution
Breda

Netherlands
Local Institution
Rotterdam

Netherlands
Local Institution
Veldhoven

Peru
Clinica Ricardo Palma
Lima

Peru
Instituto Nacional De Enfermedades Neoplasicas
Lima

Peru
Clinica San Felipe- Unidad de Oncologia Medica
Lima

Peru
Instituto Oncologico Miraflores
Lima

Peru
Oncocenter Peru SAC - Oncosalud
Lima

Poland
Ambulatorium Chemioterapii
Bydgoszcz

Poland
Wojewodzkie Centrum Onkologii
Gdansk

Poland
Oddzial Onkologii I Radioterapii Szpital Morski Im. Pck
Gdynia

Poland
Centrum Onkologii-Inst.Im.M.Sklodowskiej-Curie O.W Gliwicach
Gliwice

Poland
Regionalny Osrodek Onkologiczny
Lodz

Poland
Klinika Nowotworow Pluca i Klatki Piersiowej
Warszawa

Poland
ORTHOS Szpital Wielospecjalistyczny Sp. z o.o.
Wroclaw

Romania
Institutul Clinic Fundeni
Bucharest

Romania
Sf. Nectarie Oncology Center
Craiova

Romania
S.C. Radiotherapy Center Cluj S.R.L.
Floresti

Romania
Prof. Dr. Ion Chiricuta Institute Of Oncology Day Care Dep
Romania

Russian Federation
Local Institution
Chelyabinsk

Russian Federation
Local Institution
Kazan

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Saint-Petersburg

Russian Federation
Local Institution
St. Petersburg

Russian Federation
Local Institution
St. Petersburg

Russian Federation
Local Institution
Ufa

Saudi Arabia
Local Institution
Riyadh 11426

Saudi Arabia
Local Institution
Riyadh-11211

South Africa, Gauteng
Local Institution
Johannesburg

South Africa, Gauteng
Local Institution
Pretoria

South Africa, Gauteng
Local Institution
Saxonwold, Johannesburg

South Africa
Local Institution
Vereeniging

Spain, Madrid
Local Institution
Majadahonda

Spain
Local Institution
Badalona (Barcelona)

Spain
Local Institution
Barcelona

Spain
Local Institution
Madrid

Spain
Local Institution
Sevilla

Spain
Local Institution
Valencia

Switzerland
Klinik Fur Onkologie
Basel

Switzerland
Kantonsspital Graubuenden
Chur

Switzerland
Centre hospitalier universitaire Vaudois (CHUV)
Lausanne

Switzerland
Local Institution
Winterthur

Taiwan
Local Institution
Taichung

Taiwan
Local Institution
Taipei

Taiwan
Local Institution
Taipei

Taiwan
Local Institution
Taipei

Taiwan
Local Institution
Tao-Yuan County

Turkey
Local Institution
Ankara

Turkey
Local Institution
Antalya

Turkey
Local Institution
Kayseri

United Arab Emirates
Local Institution
Al Ain

United Kingdom, Cleveland
Local Institution
Middlesborough

United Kingdom, Greater London
Local Institution
London

United Kingdom, Greater London
Local Institution
London

United Kingdom, Greater London
Local Institution
London

United Kingdom, Hampshire
Local Institution
Southampton

United Kingdom, Leicestershire
Local Institution
Leicester

United Kingdom, WEST Midlands
Local Institution
Birmingham

United Kingdom
Local Institution
Cambridgeshire

United Kingdom
Local Institution
Edinburgh

United Kingdom
Local Institution
Surrey

Sponsors and Collaborators

Bristol-Myers Squibb

Ono Pharmaceutical Co. Ltd

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT02477826 History of Changes
  • Other Study ID Numbers: CA209-227, 2014-003630-23
  • First Posted: June 23, 2015 Key Record Dates
  • Last Update Posted: September 21, 2021
  • Last Verified: September 2021
  • Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung Lung Neoplasms