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
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 9
- Locations
- 21
- Primary Endpoint
- Overall Survival of Participants During the Study - All Treated Participants
Study Overview
Brief Summary
The purpose of this trial is to determine whether Ipilimumab will prolong survival when compared to Pemetrexed in subjects with nonsquamous, non-small cell lung cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Non-Squamous, Non-Small Cell Lung Cancer
- •Recurrent/Stage IV Non-small cell lung cancer (NSCLC)
- •Eastern Cooperative Oncology Group (ECOG) 0 or 1
- •Not progressing after 4 cycles of a platinum-based first line chemotherapy
Exclusion Criteria
- •Brain Metastases (unless stable)
- •Autoimmune Diseases
Outcomes
Primary Outcomes
Overall Survival of Participants During the Study - All Treated Participants
Time Frame: Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started
Overall survival (OS) was defined as the time from the date of randomization until the date of death. For those participants who did not die by the time the study was terminated and last patient, last visit occurred, OS was censored (+) on the last date the participant was known to be alive. OS is presented below in increasing monthly categories of survival. OS analysis was to be performed when a total of approximately 132 deaths were observed but due to the early termination of the study, statistical analyses were not performed.
Secondary Outcomes
- Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants(Day 1 of Treatment to Date of Death, up to last patient, last visit, approximately 7 months after study started.)
- Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants(Day 1 to Date of last patient, last visit, approximately 7 months after study started.)