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

July 19, 2023 updated by: Bristol-Myers Squibb

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

569

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Murdoch, Australia, 6150
        • Local Institution - 0027
    • New South Wales
      • Waratah, New South Wales, Australia, 2298
        • Local Institution - 0102
    • Queensland
      • Brisbane, Queensland, Australia, 4032
        • Local Institution - 0030
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Local Institution - 0031
      • Kurralta Park, South Australia, Australia, 5037
        • Local Institution - 0103
    • Western Australia
      • Perth, Western Australia, Australia, 6150
        • Local Institution - 0028
  • Austria
      • Graz, Austria, 8036
        • Local Institution - 0085
      • Wels, Austria, 4600
        • Local Institution - 0084
      • Wien, Austria, 1090
        • Local Institution - 0086
  • Belgium
      • Bruxelles, Belgium, 1200
        • Local Institution - 0013
      • Edegem, Belgium, 2650
        • Local Institution - 0012
      • Leuven, Belgium, 3000
        • Local Institution - 0011
      • Yvoir, Belgium, 5530
        • Local Institution - 0010
  • Brazil
      • Sao Paulo, Brazil, 01321-001
        • Local Institution - 0099
    • RIO Grande DO SUL
      • Ijui, RIO Grande DO SUL, Brazil, 98700-000
        • Local Institution - 0095
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Local Institution - 0094
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14784-400
        • Local Institution - 0093
  • Chile
    • Santiago De Chile
      • Recoleta, Santiago De Chile, Chile
        • Local Institution - 0025
  • China
      • Beijing, China, 100071
        • Local Institution - 0201
      • Guangzhou, China
        • Local Institution - 0198
      • Hangzhou, China, 310016
        • Local Institution - 0182
      • Shanghai, China, 200030
        • Local Institution - 0192
    • Beijing
      • Beijing, Beijing, China, 100001
        • Local Institution - 0200
      • Beijing, Beijing, China, 100021
        • Local Institution - 0199
      • Beijing, Beijing, China, 100032
        • Local Institution - 0188
      • Beijing, Beijing, China, 101149
        • Local Institution - 0190
    • Guangdong
      • Guanzhou, Guangdong, China, 510080
        • Local Institution - 0197
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Local Institution - 0189
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Local Institution - 0194
    • Jilin
      • Changchun, Jilin, China, 130012
        • Local Institution - 0187
    • Shaanxi
      • Xian, Shaanxi, China, 710038
        • Local Institution - 0186
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Local Institution - 0181
      • Shanghai, Shanghai, China, 200032
        • Local Institution - 0185
    • Xinjiang
      • Urumqi, Xinjiang, China, 830011
        • Local Institution - 0202
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Local Institution - 0183
  • Czechia
      • Brno, Czechia, 625 00
        • Local Institution - 0069
      • Brno, Czechia, 656 53
        • Local Institution - 0067
      • Olomouc, Czechia, 779 00
        • Local Institution - 0068
      • Praha 4, Czechia, 14059
        • Local Institution - 0066
  • Denmark
      • Copenhagen, Denmark, 2100
        • Local Institution - 0106
      • Herlev, Denmark, 2730
        • Local Institution - 0098
      • Odense, Denmark, 5000
        • Local Institution - 0100
  • France
      • Brest, France, 29200
        • Local Institution - 0134
      • Lille Cedex, France, 59037
        • Local Institution - 0116
      • Paris Cedex 14, France, 75014
        • Local Institution - 0118
      • Pringy Cedex, France, 74374
        • Local Institution - 0131
      • Reims, France, 51100
        • Local Institution - 0132
      • Toulon Cedex, France, 83056
        • Local Institution - 0117
  • Germany
      • Bamberg, Germany, 96049
        • Local Institution - 0061
      • Berlin, Germany, 13125
        • Local Institution - 0055
      • Essen, Germany, 45122
        • Local Institution - 0047
      • Frankfurt am Main, Germany, 60590
        • Local Institution - 0071
      • Gera, Germany, 07548
        • Local Institution - 0060
      • Gerlingen, Germany, 70839
        • Local Institution - 0019
      • Grosshansdorf, Germany, 22927
        • Local Institution - 0021
      • Halle (saale), Germany, 06120
        • Local Institution - 0058
      • Hamburg, Germany, 21075
        • Local Institution - 0059
      • Heidelberg, Germany, 69126
        • Local Institution - 0020
      • Immenstadt, Germany, 87509
        • Local Institution - 0046
      • Koeln, Germany, 50937
        • Local Institution - 0023
      • Muenchen, Germany, 81925
        • Local Institution - 0022
      • Oberhausen, Germany, 46145
        • Local Institution - 0054
      • Regensburg, Germany, 93053
        • Local Institution - 0064
  • Greece
      • Athens, Greece, 11527
        • Local Institution - 0062
      • Thessaloniki, Greece, 56429
        • Local Institution - 0097
    • Creta
      • Heraklion, Creta, Greece, 71110
        • Local Institution - 0063
  • Hungary
      • Budapest, Hungary, 1083
        • Local Institution - 0112
      • Budapest, Hungary, 1121
        • Local Institution - 0110
      • Budapest, Hungary, 1121
        • Local Institution - 0150
  • Israel
      • Beer Sheva, Israel, 84101
        • Local Institution - 0139
      • Kfar Saba, Israel
        • Local Institution - 0138
      • Ramat -Gan, Israel, 52621
        • Local Institution - 0136
      • Safed, Israel, 13100
        • Local Institution - 0166
  • Italy
      • Bologna, Italy, 40139
        • Local Institution - 0081
      • Livorno, Italy, 57100
        • Local Institution - 0073
      • Lucca, Italy, 55100
        • Local Institution - 0108
      • Meldola, Italy, 47014
        • Local Institution - 0077
      • Milano, Italy, 20133
        • Local Institution - 0078
      • Monza, Italy, 20052
        • Local Institution - 0080
      • Rimini, Italy, 47923
        • Local Institution - 0107
      • Roma, Italy, 00189
        • Local Institution - 0079
  • Japan
      • Tokyo, Japan, 135-8550
        • Local Institution - 0154
    • Aichi
      • Nagoya, Aichi, Japan, 460-0001
        • Local Institution - 0169
      • Nagoya-shi, Aichi, Japan, 4648681
        • Local Institution - 0159
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Local Institution - 0196
    • Ehime
      • Matsuyama, Ehime, Japan, 7910280
        • Local Institution - 0155
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 811-1395
        • Local Institution - 0153
    • Hyogo
      • Akashi-shi, Hyogo, Japan, 6738558
        • Local Institution - 0168
      • Kobe, Hyogo, Japan, 6500047
        • Local Institution - 0163
    • Miyagi
      • Natori-shi, Miyagi, Japan, 9811293
        • Local Institution - 0164
    • Niigata
      • Niigata-shi, Niigata, Japan, 951-8566
        • Local Institution - 0161
    • Osaka
      • Habikino-shi, Osaka, Japan, 5838588
        • Local Institution - 0171
      • Hirakata-shi, Osaka, Japan, 5731191
        • Local Institution - 0175
      • Osaka-sayama, Osaka, Japan, 589-8511
        • Local Institution - 0151
      • Osaka-shi, Osaka, Japan, 5340021
        • Local Institution - 0165
      • Sakai, Osaka, Japan, 591-8555
        • Local Institution - 0160
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 362-0806
        • Local Institution - 0162
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138431
        • Local Institution - 0176
      • Chuo-ku, Tokyo, Japan, 1040045
        • Local Institution - 0170
      • Chuo-ku, Tokyo, Japan, 5418567
        • Local Institution - 0174
    • Wakayama
      • Wakayama-Shi, Wakayama, Japan, 641-8510
        • Local Institution - 0152
  • Korea, Republic of
      • Cheongju-si, Korea, Republic of, 28644
        • Local Institution - 0146
      • Seoul, Korea, Republic of, 02841
        • Local Institution - 0147
      • Seoul, Korea, Republic of, 05505
        • Local Institution - 0148
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 16247
        • Local Institution - 0145
  • Norway
      • Bergen, Norway, 5021
        • Local Institution - 0096
      • Oslo, Norway, 0424
        • Local Institution - 0072
  • Poland
      • Elblag, Poland, 82-300
        • Local Institution - 0044
      • Gdansk, Poland, 80-214
        • Local Institution - 0041
      • Krakow, Poland, 31-202
        • Local Institution - 0032
      • Lodz, Poland, 93-513
        • Local Institution - 0033
      • Poznan, Poland, 60-569
        • Local Institution - 0042
      • Warszawa, Poland, 02-781
        • Local Institution - 0035
  • Romania
      • Bucharest, Romania, 020122
        • Local Institution - 0135
      • Craiova, Romania, 200347
        • Local Institution - 0114
      • Romania, Romania, 400015
        • Local Institution - 0113
      • Timisoara, Timis, Romania, 300239
        • Local Institution - 0149
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Local Institution - 0122
      • Ryazan, Russian Federation, 390011
        • Local Institution - 0121
      • Saint-Petersburg, Russian Federation, 197758
        • Local Institution - 0126
      • St. Petersburg, Russian Federation, 194291
        • Local Institution - 0119
  • Spain
      • Barcelona, Spain, 08025
        • Local Institution - 0006
      • Barcelona, Spain, 08035
        • Local Institution - 0005
      • Madrid, Spain, 28034
        • Local Institution - 0004
      • Madrid, Spain, 28050
        • Local Institution - 0003
      • Sevilla, Spain, 41009
        • Local Institution - 0008
      • Valencia, Spain, 46026
        • Local Institution - 0007
  • Switzerland
      • Basel, Switzerland, 4031
        • Local Institution - 0104
      • Lausanne, Switzerland, 1011
        • Local Institution - 0133
      • Winterthur, Switzerland, 8401
        • Local Institution - 0109
      • Zurich, Switzerland, 8091
        • Local Institution - 0156
  • Taiwan
      • Taichung, Taiwan, 404
        • Local Institution - 0143
  • United Kingdom
      • Southampton, United Kingdom, SO16 6YD
        • Local Institution - 0123
    • Greater London
      • London, Greater London, United Kingdom, SW3 6JJ
        • Local Institution - 0157
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4XB
        • Local Institution - 0082
    • Kent
      • Maidstone, Kent, United Kingdom, ME16 9QQ
        • Local Institution - 0083
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Local Institution - 0124
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Local Institution - 0065
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Local Institution - 0024
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 0018
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Local Institution - 0056
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Local Institution - 0088
    • New York
      • Johnson City, New York, United States, 13790
        • Local Institution - 0173
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Local Institution - 0001
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Local Institution - 0090
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Local Institution - 0002
      • Lancaster, Pennsylvania, United States, 17604
        • Local Institution - 0057
      • Philadelphia, Pennsylvania, United States, 19111-2412
        • Local Institution - 0053
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Local Institution - 0089
      • Nashville, Tennessee, United States, 37232
        • Local Institution - 0009
    • Washington
      • Kennewick, Washington, United States, 99336
        • Local Institution - 0070

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: OS was followed continuously while participants were on the study drug and every 3 months, minimum follow up for overall survival was 15.8 months
The time from randomization to the date of death, data was based on Kaplan-Meier Estimates. A participant who has not died will be censored at last known date alive.
OS was followed continuously while participants were on the study drug and every 3 months, minimum follow up for overall survival was 15.8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From randomization to the date of first documented tumor progression, or death due to any cause. Tumor response assessed every 6 weeks from first dose until week 30, and every 12 weeks (Up to approximately 80 months)

PFS is defined as the time from randomization to the date of the first documented tumor progression based on investigator assessment (per RECIST 1.1), or death due to any cause. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on the date they were randomized. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last evaluable tumor assessment prior to initiation of the subsequent anti-cancer therapy.

Progressive disease (PD)= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must demonstrate an absolute increase of at least 5 mm.
From randomization to the date of first documented tumor progression, or death due to any cause. Tumor response assessed every 6 weeks from first dose until week 30, and every 12 weeks (Up to approximately 80 months)
Objective Response Rate (ORR)
Time Frame: From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 80 months)

ORR is defined as the percentage of randomized participants whose best overall response (BOR) from baseline is either a complete response (CR) or partial response (PR) based on investigator assessment per RECIST 1.1 criteria. For participants without documented progression or subsequent anti-cancer therapy, all available response designations will contribute to the BOR determination. For participants who continue nivolumab beyond progression, the BOR should be determined based on tumor assessments before initial RECIST 1.1 defined progression.

CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm.

PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Progressive disease (PD)= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must demonstrate an absolute increase of at least 5 mm.
From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 80 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2015

Primary Completion (Actual)

August 17, 2018

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

June 23, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimated)

June 25, 2015

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-331
  • 2015-001097-18 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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