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

Phase 2TerminatedNCT01471197

Bristol-Myers Squibb9 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer - Non Small Cell

Interventions

IpilimumabBIOLOGICAL

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

PemetrexedBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Marin Specialty Care, Inc.

Greenbrae, California, United States

Medical And Surgical Specialists, Llc

Galesburg, Illinois, United States

Quincy Medical Group

Quincy, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started

Secondary Outcomes

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.

Time frame: 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.

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

Data from ClinicalTrials.gov

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