Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Non-Squamous Non-Small Cell Lung Cancer

Phase 2

Terminated

• Conditions: Lung Cancer - Non Small Cell
• Interventions: Biological: Ipilimumab; Biological: Pemetrexed

• Registration Number: NCT01471197
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-10
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-15
• Study Start: 2012-07
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2014-03-06
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-14
• Last Update Submitted: 2014-04-14
• Results First Posted: 2014-05-12
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

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Exclusion Criteria

• Brain Metastases (unless stable)
• Autoimmune Diseases

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Ipilimumab	Ipilimumab	-
Arm 2: Pemetrexed	Pemetrexed	-

Primary Outcome Measures

Name	Time	Method
Overall Survival of Participants During the Study - All Treated Participants	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 Outcome Measures

Name	Time	Method
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.	Due to study termination, the categories presented below are deaths occurring within 30 days of last dose and deaths occurring within 32 days of last dose. If the study had not been terminated early, the categories presented would have been 30 days and 90 days after last dose.
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.	AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Participants were evaluated from Day 1 (first day of treatment with study drug) to the date of the last participant, last visit of the study.

Trial Locations

Locations (8)

Marin Specialty Care, Inc.; 🇺🇸 Greenbrae, California, United States

Medical And Surgical Specialists, Llc; 🇺🇸 Galesburg, Illinois, United States

Quincy Medical Group; 🇺🇸 Quincy, Illinois, United States

Carolina Biooncology Institute; 🇺🇸 Huntersville, North Carolina, United States

Meritus Center For Clinical Research; 🇺🇸 Hagerstown, Maryland, United States

Blue Ridge Cancer Care; 🇺🇸 Christiansburg, Virginia, United States

Montgomery Cancer Center; 🇺🇸 Mount Sterling, Kentucky, United States

Local Institution; 🇪🇸 Benidorm-Alicante, Spain