CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,351 enrolled
Drug / intervention
Ipilimumab +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01450761
NCT01450761Phase 3Completed
CompareCT.gov

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)

Bristol-Myers Squibb·interventional·Posted Oct 12, 2011·Updated Jul 8, 2020

In Brief

A Phase 3 clinical trial evaluating Ipilimumab, Placebo matching Ipilimumab, and 3 other interventions for Small Cell Lung Carcinoma. Completed, enrolled 1,351 participants across 225 sites in 34 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Lung Carcinoma
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 12, 2011
Enrollment StartDec 13, 2011
Primary CompletionMar 19, 2015
Study CompletionMay 17, 2017
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.7 years ago

Interventions

Ipilimumabbiological

Placebo matching Ipilimumabbiological

Etoposidedrug

Cisplatindrug

Carboplatindrug