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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
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)
Secondary ID [1] 0 0
2011-000850-48
Secondary ID [2] 0 0
CA184-156
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy
Timepoint [1] 0 0
Randomization until date of death, up to March 2015, approximately 38 months
Secondary outcome [1] 0 0
Overall Survival in All Randomized Participants
Timepoint [1] 0 0
From randomization until date of death, up to March 2015, approximately 38 months
Secondary outcome [2] 0 0
Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy
Timepoint [2] 0 0
From randomization until disease progression, up to March 2015, approximately 38 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior systemic therapy for lung cancer
* Symptomatic Central Nervous System (CNS) metastases
* History of autoimmune disease

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
Blinded (masking used)
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
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
13/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/05/2017
Sample size
Target
Accrual to date
Final
1351
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Kogarah
Recruitment hospital [2] 0 0
Local Institution - Wollongong
Recruitment hospital [3] 0 0
Local Institution - Chermside
Recruitment hospital [4] 0 0
Local Institution - Bedford Park
Recruitment hospital [5] 0 0
Local Institution - Fitzroy
Recruitment hospital [6] 0 0
Local Institution - Wodonga
Recruitment hospital [7] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3690 - Wodonga
Recruitment postcode(s) [7] 0 0
6009 - Perth
Recruitment outside Australia
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United States of America
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Arkansas
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California
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New York
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Ohio
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Virginia
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West Virginia
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Edegem
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Jilin
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Gauting
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Heidelberg
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Kassel
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Ulm
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Matrahaza
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Petah-tikva
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Ramat-gan
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Livorno
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Lucca
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Italy
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Meldola (FC)
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Okayama
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Osaka
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Oskaka
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Sapporo, Hokkaido
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Sendai, Miyagi
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Portugal
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Coimbra
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Portugal
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Lisboa
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Romania
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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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Pretoria
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Barcelona
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Castellon
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Valencia
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Stockholm
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Uppsala
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Switzerland
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Basel
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Switzerland
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Winterthur
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Thailand
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Chiang Mai
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Thailand
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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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Preston
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Sutton
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United Kingdom
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Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01450761