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

NCT01471197 | Terminated Phase 2 Results

• 2 other identifiers: CA184-124 ST2011-000732-29
• Study Type: interventional
• Target: 9
• Locations: 5 countries
• Sites: 13

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.

Conditions

Lung Cancer - Non Small Cell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants

  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

  Day 1 to Date of last patient, last visit, approximately 7 months after study started.

Study Arms (2)

Arm 1: Ipilimumab

EXPERIMENTAL

Biological: Ipilimumab

Arm 2: Pemetrexed

ACTIVE COMPARATOR

Biological: Pemetrexed

Interventions

Ipilimumab BIOLOGICAL

Intravenous (IV) solution, IV, 10mg/kg, Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion

Also known as: Yervoy, BMS-734016

Arm 1: Ipilimumab

Pemetrexed BIOLOGICAL

IV solution, IV, 500 mg/m2, Once every 3 weeks during Treatment Phase, 10 minute infusion.

Also known as: Alimta

Arm 2: Pemetrexed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Brain Metastases (unless stable)
• Autoimmune Diseases

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (13)

Marin Specialty Care, Inc.

Greenbrae, California, 94904, United States

Location

Medical And Surgical Specialists, Llc

Galesburg, Illinois, 61401, United States

Location

Quincy Medical Group

Quincy, Illinois, 62301, United States

Location

Montgomery Cancer Center

Mount Sterling, Kentucky, 40353, United States

Location

Meritus Center For Clinical Research

Hagerstown, Maryland, 21742, United States

Location

Carolina Biooncology Institute

Huntersville, North Carolina, 28078, United States

Location

Blue Ridge Cancer Care

Christiansburg, Virginia, 24073, United States

Location

Local Institution

Bruges, 8310, Belgium

Location

Local Institution

Sint-Niklaas, 9100, Belgium

Location

Local Institution

Paris, 75014, France

Location

Local Institution

Hamburg, 21075, Germany

Location

Local Institution

Heidelberg, 69126, Germany

Location

Local Institution

Benidorm-Alicante, 03501, Spain

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Ipilimumab; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Limitations and Caveats

At the time of the early termination of this study, most participants only had only one on-study tumor assessment performed. Therefore, the tumor response-related endpoints were too immature to report.

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 15, 2011
• Study Start: July 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 12, 2014
• Results First Posted: May 12, 2014

Record last verified: 2014-04

Locations

DE (2); FR (1); US (7); BE (2); ES (1)