Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Non-Squamous Non-Small Cell Lung Cancer
Primary Purpose
Lung Cancer - Non Small Cell
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ipilimumab
Pemetrexed
Sponsored by

About this trial
This is an interventional treatment trial for Lung Cancer - Non Small Cell
Eligibility Criteria
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
Sites / Locations
- Marin Specialty Care, Inc.
- Medical And Surgical Specialists, Llc
- Quincy Medical Group
- Montgomery Cancer Center
- Meritus Center For Clinical Research
- Carolina Biooncology Institute
- Blue Ridge Cancer Care
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1: Ipilimumab
Arm 2: Pemetrexed
Arm Description
Outcomes
Primary Outcome Measures
Overall Survival of Participants During the Study - All Treated Participants
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
Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01471197
Brief Title
Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Non-Squamous Non-Small Cell Lung Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Administrative reasons
Study Start Date
July 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer - Non Small Cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Ipilimumab
Arm Type
Experimental
Arm Title
Arm 2: Pemetrexed
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy, BMS-734016
Intervention Description
Intravenous (IV) solution, IV, 10mg/kg, Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion
Intervention Type
Biological
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
Alimta
Intervention Description
IV solution, IV, 500 mg/m2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
Primary Outcome Measure Information:
Title
Overall Survival of Participants During the Study - All Treated Participants
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.
Time Frame
Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started
Secondary Outcome Measure Information:
Title
Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants
Description
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.
Time Frame
Day 1 of Treatment to Date of Death, up to last patient, last visit, approximately 7 months after study started.
Title
Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants
Description
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.
Time Frame
Day 1 to Date of last patient, last visit, approximately 7 months after study started.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Marin Specialty Care, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Medical And Surgical Specialists, Llc
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Quincy Medical Group
City
Quincy
State/Province
Illinois
ZIP/Postal Code
62301
Country
United States
Facility Name
Montgomery Cancer Center
City
Mount Sterling
State/Province
Kentucky
ZIP/Postal Code
40353
Country
United States
Facility Name
Meritus Center For Clinical Research
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Carolina Biooncology Institute
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Blue Ridge Cancer Care
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
Local Institution
City
Brugge
ZIP/Postal Code
8310
Country
Belgium
Facility Name
Local Institution
City
Sint Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
Local Institution
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Local Institution
City
Benidorm-Alicante
ZIP/Postal Code
03501
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
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Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Non-Squamous Non-Small Cell Lung Cancer
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