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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02481830




Registration number
NCT02481830
Ethics application status
Date submitted
23/06/2015
Date registered
25/06/2015
Date last updated
6/08/2020

Titles & IDs
Public title
Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer
Scientific 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)
Secondary ID [1] 0 0
2015-001097-18
Secondary ID [2] 0 0
CA209-331
Universal Trial Number (UTN)
Trial acronym
CheckMate331
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nivolumab
Treatment: Drugs - Topotecan
Treatment: Drugs - Amrubicin

Experimental: Arm A Nivolumab - Nivolumab intravenous infusion as specified

Active Comparator: Arm B Chemotherapy Topotecan - Topotecan as specified

Active Comparator: Arm B Chemotherapy Amrubicin - Amrubicin intravenous infusion as specified (upon investigator's choice, where locally approved for 2nd line SCLC treatment)


Treatment: Drugs: Nivolumab


Treatment: Drugs: Topotecan


Treatment: Drugs: Amrubicin


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - The time from randomization to the date of death, data was based on Kaplan-Meier Estimates.
Timepoint [1] 0 0
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 [1] 0 0
Progression Free Survival (PFS ) - the time from randomization to the date of the first documented tumor progression (based on investigator assesment,using Response Evaluation Criteria in Solid Tumors (RECIST)1.1 criteria) or death the data was based on Kaplan-Meier Estimates.
PFS was censored when subsequent anti cancer therapy was started before progression.
Timepoint [1] 0 0
assessed every 6 weeks from the first dose to week 30, and every 12 weeks up to 34 months.
Secondary outcome [2] 0 0
Objective Response Rate (ORR) - The proportion of all randomized Participants who achieved BOR(Best Overall response) from baseline is either a CR(complete response) or PR(Partial response),using the RECIST v1.1 criteria based on investigator assessment,CR+PR, confidence interval based on the Clopper and Pearson method
Timepoint [2] 0 0
Between the date of randomization and the date of progression or the date of subsequent anti-cancer therapy,whichever occurs first up to 34 months

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com



- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Local Institution - Waratah
Recruitment hospital [2] 0 0
Local Institution - Brisbane
Recruitment hospital [3] 0 0
Local Institution - Elizabeth Vale
Recruitment hospital [4] 0 0
Local Institution - Kurralta Park
Recruitment hospital [5] 0 0
Local Institution - Perth
Recruitment hospital [6] 0 0
Local Institution - Murdoch
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
4032 - Brisbane
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
6150 - Perth
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
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Washington
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Austria
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Graz
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Wels
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Austria
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Wien
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Belgium
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Bruxelles
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Belgium
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Edegem
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Belgium
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Leuven
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Yvoir
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SAO Paulo
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Ono Pharmaceutical Co. Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy
in subjects with relapsed SCLC.
Trial website
https://clinicaltrials.gov/show/NCT02481830
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications