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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

After 816 Death Events have been observed (Interim analysis after 612 death events)

Outcome Time Frame:

Approximately 40.8 months after the first subject is randomized

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA184-156

NCT ID:

NCT01450761

Start Date:

January 2012

Completion Date:

March 2017

Related Keywords:

• Small Cell Lung Carcinoma
• Carcinoma
• Lung Neoplasms
• Small Cell Lung Carcinoma