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Trial record 1 of 1 for:    NCT02481830
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Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer (CheckMate331)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02481830
Recruitment Status : Active, not recruiting
First Posted : June 25, 2015
Last Update Posted : January 1, 2019
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Nivolumab Drug: Topotecan Drug: Amrubicin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 803 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Phase 3 Study of Nivolumab or Chemotherapy in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First Line Chemotherapy (CheckMate 331: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 331)
Actual Study Start Date : August 28, 2015
Actual Primary Completion Date : August 17, 2018
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Arm A Nivolumab
Nivolumab intravenous infusion as specified
Drug: Nivolumab
Active Comparator: Arm B Chemotherapy Topotecan
Topotecan as specified
Drug: Topotecan
Active Comparator: Arm B Chemotherapy Amrubicin
Amrubicin intravenous infusion as specified (upon investigator's choice, where locally approved for 2nd line SCLC treatment)
Drug: Amrubicin



Primary Outcome Measures :
  1. Overall survival (OS) in subjects with relapsed SCLC [ Time Frame: approximately 12 months. Additional survival follow-up may continue for up to 5 years from the completion of the study ]

Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: upto 12 months ]
  2. Objective response rate (ORR) [ Time Frame: upto 12 months ]


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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:

  • Histologically or cytologically confirmed small cell lung cancer (SCLC)
  • Subjects with either limited or extensive disease stage at the initial diagnosis
  • Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of limited or extensive disease stage SCLC
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

  • Untreated or symptomatic central nervous system (CNS) metastases
  • Prior therapy with anti-PD-1, anti-PDL1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody
  • Inadequate hematologic or hepatic function

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481830


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Locations
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United States, Arkansas
Univ Of Ark For Med Sci
Little Rock, Arkansas, United States, 72205
United States, Connecticut
Smilow Cancer Hospital. At Yale New Haven
New Haven, Connecticut, United States, 06510
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Missouri
Washington University School Of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Hematology Oncology Pc
Lincoln, Nebraska, United States, 68506
United States, New York
Broome Oncology
Johnson City, New York, United States, 13790
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States, 18015
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2412
United States, Tennessee
Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Washington
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States, 99336
Australia, New South Wales
Local Institution
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Local Institution
Brisbane, Queensland, Australia, 4032
Australia, South Australia
Local Institution
Kurralta Park, South Australia, Australia, 5037
Australia, Western Australia
Local Institution
Perth, Western Australia, Australia, 6150
Australia
Local Institution
Elizabeth Vale, Australia, 5112
Local Institution
Murdoch, Australia, 6150
Austria
Local Institution
Graz, Austria, 8036
Local Institution
Wels, Austria, 4600
Akh Wien
Wien, Austria, 1090
Belgium
Local Institution
Bruxelles, Belgium, 1200
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Edegem, Belgium, 2650
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Leuven, Belgium, 3000
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Yvoir, Belgium, 5530
Brazil
Local Institution
Ijui, RIO Grande DO SUL, Brazil, 98700-000
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Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
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Barretos, SAO Paulo, Brazil, 14784-400
Local Institution
Sao Paulo, Brazil, 01321-001
Chile
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Recoleta, Santiago DE Chile, Chile
China, Beijing
Local Institution
Beijing, Beijing, China, 100001
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Beijing, Beijing, China, 100021
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Beijing, Beijing, China, 100032
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Beijing, Beijing, China, 101149
China, Guangdong
Local Institution
Guanzhou, Guangdong, China, 510080
China, Henan
Local Institution
Zhengzhou, Henan, China, 450008
China, Jiangsu
Local Institution
Nanjing, Jiangsu, China, 210000
China, Jilin
Local Institution
Changchun, Jilin, China, 130012
China, Shaanxi
Local Institution
Xian, Shaanxi, China, 710038
China, Shanghai
Local Institution
Shanghai, Shanghai, China, 200025
Local Institution
Shanghai, Shanghai, China, 200032
China, Xinjiang
Local Institution
Urumqi, Xinjiang, China, 830011
China, Zhejiang
Local Institution
Hangzhou, Zhejiang, China, 310022
China
Local Institution
Beijing, China, 100071
Local Institution
Guangzhou, China
Local Institution
Hangzhou, China, 310016
Local Institution
Shanghai, China, 200030
Czechia
Local Institution
Brno, Czechia, 625 00
Klinika komplexni onkologicke pece
Brno, Czechia, 656 53
Klinika plicnich nemoci a tuberkulozy
Olomouc, Czechia, 779 00
Pneumologicka klinika 1. LF a TN
Praha 4, Czechia, 140 59
Denmark
Local Institution
Copenhagen, Denmark, 2100
Local Institution
Herlev, Denmark, 2730
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Odense, Denmark, 5000
France
Local Institution
Brest, France, 29200
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Lille Cedex, France, 59037
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Paris Cedex 14, France, 75014
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Pringy Cedex, France, 74374
Local Institution
Reims, France, 51100
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Toulon Cedex, France, 83056
Germany
Local Institution
Bamberg, Germany, 96049
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Berlin, Germany, 13125
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Essen, Germany, 45122
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Frankfurt am Main, Germany, 60590
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Gera, Germany, 07548
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Gerlingen, Germany, 70839
Local Institution
Grosshansdorf, Germany, 22927
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Halle (saale), Germany, 06120
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Hamburg, Germany, 21075
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Heidelberg, Germany, 69126
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Immenstadt, Germany, 87509
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Koeln, Germany, 50937
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Muenchen, Germany, 81925
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Oberhausen, Germany, 46145
Local Institution
Regensburg, Germany, 93053
Greece
University Hospital Of Heraklion
Heraklion, Creta, Greece, 71110
Sotiria General Hospital
Athens, Greece, 11527
Papageorgiou General Hospital
Thessaloniki, Greece, 56429
Hungary
Orsz.Koranyi Tbc es Pulm.Int.
Budapest, Hungary, 1121
Pulmonologiai Klinika
Budapest, Hungary, 1125
Israel
Local Institution
Beer Sheva, Israel, 84101
Local Institution
Kfar Saba, Israel
Local Institution
Ramat -Gan, Israel, 52621
Italy
Ospedale Bellaria-Maggiore
Bologna, Italy, 40139
Ospedale Civile Di Livorno
Livorno, Italy, 57100
Ospedale San Luca
Lucca, Italy, 55100
Istituto Romagnolo Per Lo Studio E La Cura Dei Tumori
Meldola, Italy, 47014
IRCCS Istituto Nazionale Tumori Milano
Milano, Italy, 20133
Azienda Ospedaliera - Nuovo Ospedale San Gerardo
Monza, Italy, 20052
Ospedale Degli Infermi
Rimini, Italy, 47923
Azienda Ospedaliera S. Andrea
Roma, Italy, 00189
Japan
Local Institution
Nagoya-shi, Aichi, Japan, 4648681
Local Institution
Nagoya, Aichi, Japan, 4600001
Local Institution
Kashiwa, Chiba, Japan, 277-8577
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Matsuyama, Ehime, Japan, 7910280
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Fukuoka-shi, Fukuoka, Japan, 811-1395
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Akashi-shi, Hyogo, Japan, 6738558
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Kobe-shi, Hyogo, Japan, 6500047
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Natori-shi, Miyagi, Japan, 9811293
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Niigata-shi, Niigata, Japan, 9518566
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Habikino-shi, Osaka, Japan, 563-8588
Local Institution
Hirakata-shi, Osaka, Japan, 5731191
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Osaka-sayama, Osaka, Japan, 589-8511
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Osaka-shi, Osaka, Japan, 5340021
Local Institution
Osaka-shi, Osaka, Japan, 537-8511
Local Institution
Sakai, Osaka, Japan, 591-8555
Local Institution
Kitaadachigun, Saitama, Japan, 362-0806
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Bunkyo-ku, Tokyo, Japan, 1138431
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Chuo-ku, Tokyo, Japan, 1040045
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Koto-ku, Tokyo, Japan, 1358550
Local Institution
Wakayama, Japan, 641-8510
Korea, Republic of
Local Institution
Cheongju-si, Chungcheonbuk-do, Korea, Republic of, 28644
Local Institution
Suwon, Gyeonggi-do, Korea, Republic of, 16247
Local Institution
Seoul, Korea, Republic of, 02841
Local Institution
Seoul, Korea, Republic of, 05505
Norway
Local Institution
Bergen, Norway, 5021
Local Institution
Oslo, Norway, 0424
Poland
Wojewodzki Szpital Zespolony W Elblagu
Elblag, Poland, 82-300
Klinika Onkologii I Radioterapii Am
Gdansk, Poland, 80211
Oddzial Onkologiczny
Krakow, Poland, 31-202
Regionalny Osrodek Onkologiczny
Lodz, Poland, 93-513
Oddzial Onkologii Klinicznej
Poznan, Poland, 60-569
Klinika Nowotworow Pluca i Klatki Piersiowej
Warszawa, Poland, 02-781
Romania
Local Institution
Bucharest, Romania, 020122
Local Institution
Craiova, Romania, 200347
Local Institution
Romania, Romania, 400015
Local Institution
Timisoara, Timis, Romania, 300239
Russian Federation
Local Institution
Moscow, Russian Federation, 115478
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Ryazan, Russian Federation, 390011
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Saint-Petersburg, Russian Federation, 197758
Local Institution
St. Petersburg, Russian Federation, 194291
Spain
Local Institution
Barcelona, Spain, 08025
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Barcelona, Spain, 08035
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Madrid, Spain, 28034
Local Institution
Madrid, Spain, 28050
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Sevilla, Spain, 41009
Local Institution
Valencia, Spain, 46026
Switzerland
Local Institution
Basel, Switzerland, 4031
Centre hospitalier universitaire Vaudois (CHUV)
Lausanne, Switzerland, 1011
Local Institution
Winterthur, Switzerland, 8401
Local Institution
Zurich, Switzerland, 8091
Taiwan
Local Institution
Taichung, Taiwan, 404
United Kingdom
Local Institution
London, Greater London, United Kingdom, SW3 6JJ
Local Institution
Manchester, Greater Manchester, United Kingdom, M20 4XB
Local Institution
Southampton, Hampshire, United Kingdom, SO16 6YD
Local Institution
Maidstone, Kent, United Kingdom, ME16 9QQ
Local Institution
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02481830     History of Changes
Other Study ID Numbers: CA209-331
2015-001097-18 ( EudraCT Number )
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018

Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Topotecan
Amrubicin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action