Clinical trial NCT01471197: Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Non-Squamous Non-Small Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer - Non Small Cell
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-11-15
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Overall Survival of Participants During the Study - All Treated Participants
timeFrame: Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started
Secondary outcomes:
measure: Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants
timeFrame: Day 1 of Treatment to Date of Death, up to last patient, last visit, approximately 7 months after study started.
measure: Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants
timeFrame: Day 1 to Date of last patient, last visit, approximately 7 months after study started.
Other outcomes:
Locations:
city: Greenbrae
country: United States
facility: Marin Specialty Care, Inc.
state: California
city: Galesburg
country: United States
facility: Medical And Surgical Specialists, Llc
state: Illinois
city: Quincy
country: United States
facility: Quincy Medical Group
state: Illinois
city: Mount Sterling
country: United States
facility: Montgomery Cancer Center
state: Kentucky
city: Hagerstown
country: United States
facility: Meritus Center For Clinical Research
state: Maryland
city: Huntersville
country: United States
facility: Carolina Biooncology Institute
state: North Carolina
city: Christiansburg
country: United States
facility: Blue Ridge Cancer Care
state: Virginia
city: Brugge
country: Belgium
facility: Local Institution
city: Sint Niklaas
country: Belgium
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Benidorm-Alicante
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: