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

• ClinicalTrials.gov Identifier: NCT01471197
• Recruitment Status: Terminated
• First Posted: November 15, 2011
• Results First Posted: May 12, 2014
• Last Update Posted: May 12, 2014
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

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.

Condition or disease	Intervention/treatment	Phase
Lung Cancer - Non Small Cell	Biological: Ipilimumab; Biological: Pemetrexed	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: July 2012
• Actual Primary Completion Date: February 2013
• Actual Study Completion Date: February 2013

Arms and Interventions

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: 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

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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 :

1. 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. ]
   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.
2. 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. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

BMS clinical trial educational resource 

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT01471197
• Other Study ID Numbers: CA184-124 ST; 2011-000732-29 ( EudraCT Number )
• First Posted: November 15, 2011
• Results First Posted: May 12, 2014
• Last Update Posted: May 12, 2014
• Last Verified: April 2014

Additional relevant MeSH terms:

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pemetrexed; Ipilimumab; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors