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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01450761
Registration number
NCT01450761
Ethics application status
Date submitted
10/10/2011
Date registered
12/10/2011
Date last updated
8/07/2020
Titles & IDs
Public title
Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone
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Scientific title
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab Plus Etoposide/Platinum Versus Etoposide/Platinum in Subjects With Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
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Secondary ID [1]
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2011-000850-48
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Secondary ID [2]
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CA184-156
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Carcinoma
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Condition category
Condition code
Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Ipilimumab+Etoposide+Cisplatin/Carboplatin - Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached
Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles
Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses
Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
Placebo comparator: Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin - Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached
Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles
Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses
Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy
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Assessment method [1]
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Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
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Timepoint [1]
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Randomization until date of death, up to March 2015, approximately 38 months
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Secondary outcome [1]
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Overall Survival in All Randomized Participants
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Assessment method [1]
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Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
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Timepoint [1]
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From randomization until date of death, up to March 2015, approximately 38 months
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Secondary outcome [2]
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Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy
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Assessment method [2]
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Progression-Free Survival was defined as the time from the date of randomization to the date of progression per modified World Health Organization (mWHO) criteria or death, whichever occured first. A participant who died without reported progression per mWHO criteria was considered progressed on the date of death. For those participants who remained alive and did not progress, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
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Timepoint [2]
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From randomization until disease progression, up to March 2015, approximately 38 months
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Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
* Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
* Eastern Cooperative Oncology Group (ECOG) of 0 or 1
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prior systemic therapy for lung cancer
* Symptomatic Central Nervous System (CNS) metastases
* History of autoimmune disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/12/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/05/2017
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Sample size
Target
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Accrual to date
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Final
1351
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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2217 - Kogarah
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2500 - Wollongong
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4032 - Chermside
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5042 - Bedford Park
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3065 - Fitzroy
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3690 - Wodonga
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6009 - Perth
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Judetul CLUJ
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Bucuresti
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Cluj
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Russian Federation
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Pyatigorsk
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Russian Federation
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Russian Federation
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St. Petersburg
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South Africa
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Pretoria
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Galicia
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Castellon
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Valencia
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Linkoping
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Basel
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Winterthur
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Zuerich
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Songkhla
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United Kingdom
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Manchester
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London
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United Kingdom
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Sutton
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United Kingdom
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Summary
Brief summary
The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.
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Trial website
https://clinicaltrials.gov/study/NCT01450761
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Trial related presentations / publications
Reck M, Luft A, Szczesna A, Havel L, Kim SW, Akerley W, Pietanza MC, Wu YL, Zielinski C, Thomas M, Felip E, Gold K, Horn L, Aerts J, Nakagawa K, Lorigan P, Pieters A, Kong Sanchez T, Fairchild J, Spigel D. Phase III Randomized Trial of Ipilimumab Plus Etoposide and Platinum Versus Placebo Plus Etoposide and Platinum in Extensive-Stage Small-Cell Lung Cancer. J Clin Oncol. 2016 Nov 1;34(31):3740-3748. doi: 10.1200/JCO.2016.67.6601. Erratum In: J Clin Oncol. 2019 Dec 1;37(34):3327. doi: 10.1200/JCO.19.02803.
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
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Results not provided in
https://clinicaltrials.gov/study/NCT01450761
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