A Randomized, Open-Label, Phase 2 Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Subjects With Recurrent/Stage IV Non-Squamous, Non-Small Cell Lung Cancer Who Have Not Progressed After Four Cycles of a Platinum-Based First Line Chemotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS)

Outcome Description:

OS will be defined as the time from the date of randomization until the date of death. For those subjects who have not died, OS will be censored on the last date the subject was known to be alive. OS analysis will perform when a total of approximately 132 deaths are observed

Outcome Time Frame:

Approximately 38 months after First Patient First Visit (FPFV)

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Study ID:

CA184-124

NCT ID:

NCT01471197

Start Date:

July 2012

Completion Date:

February 2013

Related Keywords:

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