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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01471197
First received: November 10, 2011
Last updated: June 24, 2013
Last verified: June 2013
  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 (OS) [ Time Frame: Approximately 38 months after First Patient First Visit (FPFV) ] [ Designated as safety issue: No ]

    OS will be defined as the time from the date of randomization until the date of death. For those subjects who have not died, OS will be censored on the last date the subject was known to be alive.

    OS analysis will perform when a total of approximately 132 deaths are observed



Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: Approximately 38 months after FPFV ] [ Designated as safety issue: No ]
    Progression-free survival is defined as the time between the event of disease progression per modified World Health Organization (mWHO) criteria or death and the randomization date. If the subject did not progress or die, he/she will be censored at the last tumor assessment date

  • Best Overall Response Rate (BORR) [ Time Frame: Approximately 38 months after FPFV ] [ Designated as safety issue: No ]
    The BORR will be defined as the number of subjects whose best overall response per mWHO criteria was CR or PR, divided by the total number of subjects in the all randomized subjects data set


Enrollment: 8
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
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, 2011-000732-29
Study First Received: November 10, 2011
Last Updated: June 24, 2013
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 April 17, 2014