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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02481830
Ethics application status
Date submitted
23/06/2015
Date registered
25/06/2015
Date last updated
27/07/2023

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
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)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
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)
Timepoint [1] 0 0
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)
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
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)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/08/2022
Sample size
Target
Accrual to date
Final
569
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Local Institution - 0102 - Waratah
Recruitment hospital [2] 0 0
Local Institution - 0030 - Brisbane
Recruitment hospital [3] 0 0
Local Institution - 0031 - Elizabeth Vale
Recruitment hospital [4] 0 0
Local Institution - 0103 - Kurralta Park
Recruitment hospital [5] 0 0
Local Institution - 0028 - Perth
Recruitment hospital [6] 0 0
Local Institution - 0027 - 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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
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United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
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United States of America
State/province [5] 0 0
Nebraska
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Austria
State/province [12] 0 0
Graz
Country [13] 0 0
Austria
State/province [13] 0 0
Wels
Country [14] 0 0
Austria
State/province [14] 0 0
Wien
Country [15] 0 0
Belgium
State/province [15] 0 0
Bruxelles
Country [16] 0 0
Belgium
State/province [16] 0 0
Edegem
Country [17] 0 0
Belgium
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Leuven
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Belgium
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Yvoir
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Brazil
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RIO Grande DO SUL
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Brazil
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Rio Grande Do Sul
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Brazil
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Sao Paulo
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Chile
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Santiago De Chile
Country [23] 0 0
China
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Beijing
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China
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Guangdong
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China
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Henan
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China
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Jiangsu
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China
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Jilin
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China
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Shaanxi
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China
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Shanghai
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China
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Xinjiang
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China
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Zhejiang
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China
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Guangzhou
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China
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Hangzhou
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Czechia
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Brno
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Czechia
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Olomouc
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Czechia
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Praha 4
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Denmark
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Copenhagen
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Denmark
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Herlev
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Denmark
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Odense
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France
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Brest
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France
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Lille Cedex
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France
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Paris Cedex 14
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France
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Pringy Cedex
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France
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Reims
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France
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Toulon Cedex
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Germany
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Bamberg
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Germany
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Berlin
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Germany
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Essen
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Germany
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Frankfurt am Main
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Germany
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Gera
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Germany
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Gerlingen
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Germany
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Grosshansdorf
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Germany
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Halle (saale)
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Immenstadt
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Germany
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Koeln
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Germany
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Muenchen
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Germany
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Oberhausen
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Germany
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Regensburg
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Greece
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Creta
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Greece
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Athens
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Greece
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Thessaloniki
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Hungary
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Budapest
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Israel
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Beer Sheva
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Israel
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Kfar Saba
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Israel
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Ramat -Gan
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Israel
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Safed
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Italy
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Bologna
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Italy
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Livorno
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Italy
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Lucca
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Italy
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Meldola
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Milano
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Italy
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Monza
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Italy
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Rimini
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Roma
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Aichi
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Chiba
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Ehime
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Japan
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Fukuoka
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Hyogo
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Miyagi
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Niigata
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Osaka
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Saitama
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Tokyo
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Japan
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Wakayama
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Cheongju-si
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Korea, Republic of
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Seoul
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Norway
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Bergen
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Norway
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Oslo
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Elblag
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Gdansk
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Krakow
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Lodz
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Poznan
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Poland
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Warszawa
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Romania
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Bucharest
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Romania
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Craiova
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Romania
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Romania
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Romania
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Timisoara, Timis
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Russian Federation
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Moscow
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Russian Federation
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Ryazan
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Russian Federation
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Saint-Petersburg
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Russian Federation
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St. Petersburg
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Spain
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Barcelona
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Switzerland
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Basel
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Switzerland
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Lausanne
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Switzerland
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Winterthur
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Switzerland
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Zurich
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Taiwan
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Taichung
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United Kingdom
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Greater London
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United Kingdom
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Greater Manchester
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United Kingdom
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Kent
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United Kingdom
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Surrey
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Southampton

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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02481830