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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. Identifier: NCT02481830
Recruitment Status : Active, not recruiting
First Posted : June 25, 2015
Last Update Posted : January 1, 2019
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

For more information regarding BMS clinical trial participation, please visit

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 identifier (NCT number): NCT02481830

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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
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Brisbane, Queensland, Australia, 4032
Australia, South Australia
Local Institution
Kurralta Park, South Australia, Australia, 5037
Australia, Western Australia
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Perth, Western Australia, Australia, 6150
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Elizabeth Vale, Australia, 5112
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Murdoch, Australia, 6150
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Graz, Austria, 8036
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Wels, Austria, 4600
Akh Wien
Wien, Austria, 1090
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Bruxelles, Belgium, 1200
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Edegem, Belgium, 2650
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Leuven, Belgium, 3000
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Yvoir, Belgium, 5530
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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
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Sao Paulo, Brazil, 01321-001
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Recoleta, Santiago DE Chile, Chile
China, Beijing
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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
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Guanzhou, Guangdong, China, 510080
China, Henan
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Zhengzhou, Henan, China, 450008
China, Jiangsu
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Nanjing, Jiangsu, China, 210000
China, Jilin
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Changchun, Jilin, China, 130012
China, Shaanxi
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Xian, Shaanxi, China, 710038
China, Shanghai
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Shanghai, Shanghai, China, 200025
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Shanghai, Shanghai, China, 200032
China, Xinjiang
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Urumqi, Xinjiang, China, 830011
China, Zhejiang
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Hangzhou, Zhejiang, China, 310022
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Beijing, China, 100071
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Guangzhou, China
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Hangzhou, China, 310016
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Shanghai, China, 200030
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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
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Copenhagen, Denmark, 2100
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Herlev, Denmark, 2730
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Odense, Denmark, 5000
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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
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Reims, France, 51100
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Toulon Cedex, France, 83056
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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
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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
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Regensburg, Germany, 93053
University Hospital Of Heraklion
Heraklion, Creta, Greece, 71110
Sotiria General Hospital
Athens, Greece, 11527
Papageorgiou General Hospital
Thessaloniki, Greece, 56429
Orsz.Koranyi Tbc es Pulm.Int.
Budapest, Hungary, 1121
Pulmonologiai Klinika
Budapest, Hungary, 1125
Local Institution
Beer Sheva, Israel, 84101
Local Institution
Kfar Saba, Israel
Local Institution
Ramat -Gan, Israel, 52621
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
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Nagoya-shi, Aichi, Japan, 4648681
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Nagoya, Aichi, Japan, 4600001
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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
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Hirakata-shi, Osaka, Japan, 5731191
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Osaka-sayama, Osaka, Japan, 589-8511
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Osaka-shi, Osaka, Japan, 5340021
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Osaka-shi, Osaka, Japan, 537-8511
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Sakai, Osaka, Japan, 591-8555
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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
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Wakayama, Japan, 641-8510
Korea, Republic of
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Cheongju-si, Chungcheonbuk-do, Korea, Republic of, 28644
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Suwon, Gyeonggi-do, Korea, Republic of, 16247
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Seoul, Korea, Republic of, 02841
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Seoul, Korea, Republic of, 05505
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Bergen, Norway, 5021
Local Institution
Oslo, Norway, 0424
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
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Bucharest, Romania, 020122
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Craiova, Romania, 200347
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Romania, Romania, 400015
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Timisoara, Timis, Romania, 300239
Russian Federation
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Moscow, Russian Federation, 115478
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Ryazan, Russian Federation, 390011
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Saint-Petersburg, Russian Federation, 197758
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St. Petersburg, Russian Federation, 194291
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Barcelona, Spain, 08025
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Barcelona, Spain, 08035
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Madrid, Spain, 28034
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Madrid, Spain, 28050
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Sevilla, Spain, 41009
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Valencia, Spain, 46026
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Basel, Switzerland, 4031
Centre hospitalier universitaire Vaudois (CHUV)
Lausanne, Switzerland, 1011
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Winterthur, Switzerland, 8401
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Zurich, Switzerland, 8091
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Taichung, Taiwan, 404
United Kingdom
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London, Greater London, United Kingdom, SW3 6JJ
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Manchester, Greater Manchester, United Kingdom, M20 4XB
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Southampton, Hampshire, United Kingdom, SO16 6YD
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Maidstone, Kent, United Kingdom, ME16 9QQ
Local Institution
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb 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
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Immunological
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action