Clinical trial · Interventional
Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Non-Squamous Non-Small Cell Lung Cancer
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
NCT01471197CI-TRIAL-00014490terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administrative reasons
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer - Non Small Cell | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Biological | Ipilimumab | ALIAS |
| Pemetrexed | Biological | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: Ipilimumab
- interventionNames
- Biological: Ipilimumab
- type
- ACTIVE_COMPARATOR
- label
- Arm 2: Pemetrexed
- interventionNames
- Biological: Pemetrexed
Primary outcomes (1)
- measure
- Overall Survival of Participants During the Study - All Treated Participants
- timeFrame
- Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation. 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
References
Publications (0)
Data not yet available
No reference posted for this study.