Try our beta test site
Trial record 5 of 114 for:    small cell lung ca | Open Studies

Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer (CheckMate331)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Bristol-Myers Squibb
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02481830
First received: June 23, 2015
Last updated: March 6, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.

Condition Intervention Phase
Lung Cancer
Drug: Nivolumab
Drug: Topotecan
Drug: Amrubicin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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:
  • Progression free survival (PFS) [ Time Frame: upto 12 months ]
  • Objective response rate (ORR) [ Time Frame: upto 12 months ]

Estimated Enrollment: 558
Actual Study Start Date: August 2015
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02481830

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 #.

  Hide Study Locations
Locations
United States, Arkansas
Univ Of Ark For Med Sci Completed
Little Rock, Arkansas, United States, 72205
United States, Connecticut
Smilow Cancer Hospital. At Yale New Haven Active, not recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
H. Lee Moffitt Cancer Center Withdrawn
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute. Completed
Atlanta, Georgia, United States, 30322
United States, Missouri
Washington University School Of Medicine Active, not recruiting
St Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Hematology Oncology Pc Active, not recruiting
Lincoln, Nebraska, United States, 68506
United States, New York
Broome Oncology Active, not recruiting
Johnson City, New York, United States, 13790
United States, North Carolina
Duke Cancer Center Completed
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospitals Cleveland Medical Center Active, not recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
St. Luke'S University Health Network Completed
Bethlehem, Pennsylvania, United States, 18015
Lancaster General Hospital Completed
Lancaster, Pennsylvania, United States, 17604
Fox Chase Cancer Center Active, not recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Tennessee Oncology, Pllc Active, not recruiting
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center Completed
Nashville, Tennessee, United States, 37232
United States, Washington
Kadlec Clinic Hematology And Oncology Completed
Kennewick, Washington, United States, 99336
Australia, New South Wales
Local Institution Completed
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Local Institution Completed
Brisbane, Queensland, Australia, 4032
Australia, South Australia
Local Institution Active, not recruiting
Elizabeth Vale, South Australia, Australia, 5112
Local Institution Completed
Kurralta Park, South Australia, Australia, 5037
Australia, Western Australia
Local Institution Active, not recruiting
Perth, Western Australia, Australia, 6150
Australia
Local Institution Completed
Murdoch, Australia, 6150
Austria
Local Institution Active, not recruiting
Graz, Austria, 8036
Local Institution Active, not recruiting
Wels, Austria, 4600
Akh Wien Active, not recruiting
Wien, Austria, 1090
Belgium
Local Institution Active, not recruiting
Bruxelles, Belgium, 1200
Local Institution Active, not recruiting
Edegem, Belgium, 2650
Local Institution Completed
Leuven, Belgium, 3000
Local Institution Active, not recruiting
Yvoir, Belgium, 5530
Brazil
Local Institution Active, not recruiting
Ijui, Rio Grande do Sul, Brazil, 98700
Local Institution Active, not recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90610
Local Institution Active, not recruiting
Barretos, Sao Paulo, Brazil, 14784
Local Institution Active, not recruiting
Sao Paulo, Brazil, 01321
Chile
Local Institution Completed
Recoleta, Santiago de Chile, Chile
China, Beijing
Local Institution Recruiting
Beijing, Beijing, China, 100001
Contact: Site 0200         
Local Institution Recruiting
Beijing, Beijing, China, 100032
Contact: Site 0188         
Local Institution Recruiting
Beijing, Beijing, China, 101149
Contact: Site 0190         
China, Guangdong
Local Institution Completed
Guanzhou, Guangdong, China, 510080
China, Henan
Local Institution Recruiting
Zhengzhou, Henan, China, 450008
Contact: Site 0189         
China, Jiangsu
Local Institution Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Site 0194         
China, Jilin
Local Institution Recruiting
Changchun, Jilin, China, 130012
Contact: Site 0187         
China, Shaanxi
Local Institution Recruiting
Xian, Shaanxi, China, 710038
Contact: Site 0186         
China, Shanghai
Local Institution Recruiting
Shanghai, Shanghai, China, 200025
Contact: Site 0181         
Local Institution Recruiting
Shanghai, Shanghai, China, 200032
Contact: Site 0185         
China, Xinjiang
Local Institution Recruiting
Urumqi, Xinjiang, China, 830011
Contact: Site 0202         
China, Zhejiang
Local Institution Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Site 0183         
China
Local Institution Recruiting
Beijing, China, 100071
Contact: Site 0201         
Local Institution Recruiting
Guangzhou, China
Contact: Site 0198         
Local Institution Recruiting
Hangzhou, China, 310016
Contact: Site 0182         
Local Institution Recruiting
Shanghai, China, 200030
Contact: Site 0192         
Czech Republic
Local Institution Active, not recruiting
Brno, Czech Republic, 625 00
Klinika Komplexni Onkologicke Pece Completed
Brno, Czech Republic, 656 53
Klinika Plicnich Nemoci A Tuberkulozy Completed
Olomouc, Czech Republic, 779 00
Pneumologicka Klinika 1. Lf A Tn Completed
Praha 4, Czech Republic, 140 59
Denmark
Local Institution Active, not recruiting
Copenhagen, Denmark, 2100
Local Institution Active, not recruiting
Herlev, Denmark, 2730
Local Institution Active, not recruiting
Odense, Denmark, 5000
France
Local Institution Active, not recruiting
Brest, France, 29200
Local Institution Active, not recruiting
Lille Cedex, France, 59037
Local Institution Active, not recruiting
Paris Cedex 14, France, 75014
Local Institution Active, not recruiting
Pringy Cedex, France, 74374
Local Institution Completed
Reims, France, 51100
Local Institution Active, not recruiting
Toulon Cedex, France, 83056
Germany
Local Institution Active, not recruiting
Bamberg, Germany, 96049
Local Institution Active, not recruiting
Berlin, Germany, 13125
Local Institution Active, not recruiting
Essen, Germany, 45122
Local Institution Active, not recruiting
Frankfurt am Main, Germany, 60590
Local Institution Active, not recruiting
Gera, Germany, 07548
Local Institution Completed
Gerlingen, Germany, 70839
Local Institution Active, not recruiting
Grosshansdorf, Germany, 22927
Local Institution Active, not recruiting
Halle (saale), Germany, 06120
Local Institution Active, not recruiting
Hamburg, Germany, 21075
Local Institution Active, not recruiting
Heidelberg, Germany, 69126
Local Institution Completed
Immenstadt, Germany, 87509
Local Institution Active, not recruiting
Koeln, Germany, 50937
Local Institution Completed
Munich, Germany, 81925
Local Institution Active, not recruiting
Oberhausen, Germany, 46145
Local Institution Completed
Regensburg, Germany, 93053
Greece
Local Institution Active, not recruiting
Athens, Greece, 11527
Local Institution Completed
Heraklio, Greece, 71110
Local Institution Completed
Thessaloniki, Greece, 57010
Hungary
Orsz.Koranyi Tbc Es Pulm.Int. Completed
Budapest, Hungary, 1121
Pulmonologiai Klinika Active, not recruiting
Budapest, Hungary, 1125
Israel
Local Institution Completed
Beer Sheva, Israel, 84101
Local Institution Active, not recruiting
Kfar Saba, Israel
Local Institution Active, not recruiting
Ramat -Gan, Israel, 52621
Local Institution Withdrawn
Safed, Israel, 13100
Italy
Local Institution Active, not recruiting
Bologna, Italy, 40139
Local Institution Completed
Livorno, Italy, 57100
Local Institution Active, not recruiting
Lucca, Italy, 55100
Local Institution Active, not recruiting
Meldola, Italy, 47014
Local Institution Active, not recruiting
Milano, Italy, 20133
Local Institution Active, not recruiting
Monza, Italy, 20052
Local Institution Completed
Rimini, Italy, 47923
Local Institution Active, not recruiting
Roma, Italy, 00189
Japan
Local Institution Active, not recruiting
Nagoya-shi, Aichi, Japan, 4648681
Local Institution Active, not recruiting
Nagoya, Aichi, Japan, 4600001
Local Institution Completed
Kashiwa, Chiba, Japan, 277-8577
Local Institution Completed
Matsuyama, Ehime, Japan, 7910280
Local Institution Active, not recruiting
Fukuoka-shi, Fukuoka, Japan, 811-1395
Local Institution Active, not recruiting
Akashi-shi, Hyogo, Japan, 6738558
Local Institution Active, not recruiting
Kobe-shi, Hyogo, Japan, 6500047
Local Institution Active, not recruiting
Natori-shi, Miyagi, Japan, 9811293
Local Institution Completed
Niigata-shi, Niigata, Japan, 9518566
Local Institution Active, not recruiting
Habikino-shi, Osaka, Japan, 563-8588
Local Institution Active, not recruiting
Hirakata-shi, Osaka, Japan, 5731191
Local Institution Completed
Osaka-sayama, Osaka, Japan, 589-8511
Local Institution Completed
Osaka-shi, Osaka, Japan, 5340021
Local Institution Completed
Osaka-shi, Osaka, Japan, 537-8511
Local Institution Active, not recruiting
Sakai, Osaka, Japan, 591-8555
Local Institution Completed
Kitaadachigun, Saitama, Japan, 362-0806
Local Institution Active, not recruiting
Bunkyo-ku, Tokyo, Japan, 1138431
Local Institution Active, not recruiting
Chuo-ku, Tokyo, Japan, 1040045
Local Institution Active, not recruiting
Koto-ku, Tokyo, Japan, 1358550
Local Institution Active, not recruiting
Wakayama, Japan, 641-8510
Korea, Republic of
Local Institution Active, not recruiting
Cheongju-si, Chungcheonbuk-do, Korea, Republic of, 28644
Local Institution Completed
Suwon, Gyeonggi-do, Korea, Republic of, 16247
Local Institution Completed
Seoul, Korea, Republic of, 02841
Local Institution Active, not recruiting
Seoul, Korea, Republic of, 05505
Norway
Local Institution Active, not recruiting
Bergen, Norway, 5021
Local Institution Active, not recruiting
Oslo, Norway, 0424
Poland
Wojewodzki Szpital Zespolony W Elblagu Active, not recruiting
Elblag, Poland, 82-300
Klinika Onkologii I Radioterapii Am Active, not recruiting
Gdansk, Poland, 80211
Oddzial Onkologiczny Active, not recruiting
Krakow, Poland, 31-202
Regionalny Osrodek Onkologiczny Active, not recruiting
Lodz, Poland, 93-513
Oddzial Onkologii Klinicznej Active, not recruiting
Poznan, Poland, 60-569
Klinika Nowotworow Pluca I Klatki Piersiowej Active, not recruiting
Warszawa, Poland, 02-781
Romania
Local Institution Active, not recruiting
Bucharest, Romania, 020122
Local Institution Active, not recruiting
Craiova, Romania, 200347
Local Institution Active, not recruiting
Romania, Romania, 400015
Local Institution Active, not recruiting
Timisoara, Timis, Romania, 300239
Russian Federation
Local Institution Active, not recruiting
Moscow, Russian Federation, 115478
Local Institution Completed
Ryazan, Russian Federation, 390011
Local Institution Completed
Saint-Petersburg, Russian Federation, 197758
Local Institution Active, not recruiting
St. Petersburg, Russian Federation, 194291
Spain
Local Institution Completed
Barcelona, Spain, 08025
Local Institution Active, not recruiting
Barcelona, Spain, 08035
Local Institution Active, not recruiting
Madrid, Spain, 28034
Local Institution Completed
Madrid, Spain, 28050
Local Institution Active, not recruiting
Sevilla, Spain, 41009
Local Institution Active, not recruiting
Valencia, Spain, 46026
Switzerland
Local Institution Completed
Basel, Switzerland, 4031
Centre Hospitalier Universitaire Vaudois (Chuv) Active, not recruiting
Lausanne, Switzerland, 1011
Local Institution Active, not recruiting
Winterthur, Switzerland, 8401
Local Institution Active, not recruiting
Zurich, Switzerland, 8091
Taiwan
Local Institution Completed
Taichung, Taiwan, 404
Local Institution Active, not recruiting
Taipei, Taiwan, 112
United Kingdom
Local Institution Active, not recruiting
London, Greater London, United Kingdom, SW3 6JJ
Local Institution Active, not recruiting
Manchester, Greater Manchester, United Kingdom, M20 4XB
Local Institution Completed
Southampton, Hampshire, United Kingdom, SO16 6YD
Local Institution Active, not recruiting
Maidstone, Kent, United Kingdom, ME16 9QQ
Local Institution Active, not recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02481830     History of Changes
Other Study ID Numbers: CA209-331
2015-001097-18 ( EudraCT Number )
Study First Received: June 23, 2015
Last Updated: March 6, 2017

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

ClinicalTrials.gov processed this record on March 28, 2017