Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non Small Cell Lung Cancer (NSCLC)

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 (defined as the time from the date of randomization until the date of death or the last known date the subject was alive)

Outcome Description:

Until 705 Death Events have occurred, Interim analysis at 528 events

Outcome Time Frame:

Approximately 48 months post study start

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:

CA184-104

NCT ID:

NCT01285609

Start Date:

August 2011

Completion Date:

December 2016

Related Keywords:

• Lung Cancer - Non Small Cell
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms