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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other interventions - Ipilimumab
Other interventions - Placebo matching Ipilimumab
Treatment: Drugs - Etoposide
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin

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


Other interventions: Ipilimumab


Other interventions: Placebo matching Ipilimumab


Treatment: Drugs: Etoposide


Treatment: Drugs: Cisplatin


Treatment: Drugs: Carboplatin
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
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
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Local Institution - Wollongong
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Local Institution - Chermside
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Local Institution - Bedford Park
Recruitment hospital [5] 0 0
Local Institution - Fitzroy
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Local Institution - Wodonga
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Local Institution - Perth
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2217 - Kogarah
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2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
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3065 - Fitzroy
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3690 - Wodonga
Recruitment postcode(s) [7] 0 0
6009 - Perth
Recruitment outside Australia
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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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01450761
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01450761