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

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.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer - Non Small Cell
• Intervention / Treatment: Biological: Ipilimumab; Biological: Pemetrexed

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium, 8310
    • Local Institution
  • Sint Niklaas, Belgium, 9100
    • Local Institution
• France
  • Paris, France, 75014
    • Local Institution
• Germany
  • Hamburg, Germany, 21075
    • Local Institution
  • Heidelberg, Germany, 69126
    • Local Institution
• Spain
  • Benidorm-Alicante, Spain, 03501
    • Local Institution
• United States
  • California
    • Greenbrae, California, United States, 94904
      • Marin Specialty Care, Inc.
  • Illinois
    • Galesburg, Illinois, United States, 61401
      • Medical And Surgical Specialists, Llc
    • Quincy, Illinois, United States, 62301
      • Quincy Medical Group
  • Kentucky
    • Mount Sterling, Kentucky, United States, 40353
      • Montgomery Cancer Center
  • Maryland
    • Hagerstown, Maryland, United States, 21742
      • Meritus Center for Clinical Research
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Carolina BioOncology Institute
  • Virginia
    • Christiansburg, Virginia, United States, 24073
      • Blue Ridge Cancer Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: BMS-734016; Yervoy
Active Comparator: Arm 2: Pemetrexed	Biological: Pemetrexed; IV solution, IV, 500 mg/m2, Once every 3 weeks during Treatment Phase, 10 minute infusion.; Other Names: Alimta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 of Treatment to Date of Death, up to last patient, last visit, approximately 7 months after study started.
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.	Day 1 to Date of last patient, last visit, approximately 7 months after study started.

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: November 10, 2011
• First Submitted That Met QC Criteria: November 14, 2011
• First Posted (Estimate): November 15, 2011

Study Record Updates

• Last Update Posted (Estimate): May 12, 2014
• Last Update Submitted That Met QC Criteria: April 14, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Folic Acid Antagonists; Pemetrexed; Ipilimumab
• Other Study ID Numbers: CA184-124 ST; 2011-000732-29 (EudraCT Number)