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

This study has been terminated.
(Administrative reasons)
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01471197
First received: November 10, 2011
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Lung Cancer - Non Small Cell
Biological: Ipilimumab
Biological: Pemetrexed
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 of Treatment to Date of Death, up to last patient, last visit, approximately 7 months after study started. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 to Date of last patient, last visit, approximately 7 months after study started. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 9
Study Start Date: July 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Ipilimumab Biological: Ipilimumab
Intravenous (IV) solution, IV, 10mg/kg, Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion
Other Names:
  • Yervoy
  • BMS-734016
Active Comparator: Arm 2: Pemetrexed Biological: Pemetrexed
IV solution, IV, 500 mg/m2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
Other Name: Alimta

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471197

Locations
United States, California
Marin Specialty Care, Inc.
Greenbrae, California, United States, 94904
United States, Illinois
Medical And Surgical Specialists, Llc
Galesburg, Illinois, United States, 61401
Quincy Medical Group
Quincy, Illinois, United States, 62301
United States, Kentucky
Montgomery Cancer Center
Mount Sterling, Kentucky, United States, 40353
United States, Maryland
Meritus Center For Clinical Research
Hagerstown, Maryland, United States, 21742
United States, North Carolina
Carolina Biooncology Institute
Huntersville, North Carolina, United States, 28078
United States, Virginia
Blue Ridge Cancer Care
Christiansburg, Virginia, United States, 24073
Belgium
Local Institution
Brugge, Belgium, 8310
Local Institution
Sint Niklaas, Belgium, 9100
France
Local Institution
Paris, France, 75014
Germany
Local Institution
Hamburg, Germany, 21075
Local Institution
Heidelberg, Germany, 69126
Spain
Local Institution
Benidorm-Alicante, Spain, 03501
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01471197     History of Changes
Other Study ID Numbers: CA184-124 ST, 2011-000732-29
Study First Received: November 10, 2011
Results First Received: March 6, 2014
Last Updated: April 14, 2014
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Poland: Ministry of Science and Higher Education
Poland: National Institute of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 22, 2014