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
18 Years
N/A
Both
Lung Cancer - Non Small Cell
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival (OS)
Outcome Description:
OS will be defined as the time from the date of randomization until the date of death. For those subjects who have not died, OS will be censored on the last date the subject was known to be alive. OS analysis will perform when a total of approximately 132 deaths are observed
Outcome Time Frame:
Approximately 38 months after First Patient First Visit (FPFV)
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Study ID:
CA184-124
NCT ID:
NCT01471197
Start Date:
July 2012
Completion Date:
February 2013
Related Keywords:
- Lung Cancer - Non Small Cell
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Medical and Surgical Specialists, LLC | Galesburg, Illinois 61401 |
| Carolina BioOncology Institute | Huntersville, North Carolina 28078 |
| Montgomery Cancer Center | Mt. Sterling, Kentucky 40353 |
| Quincy Medical Group | Quincy, Illinois 62301 |
| Blue Ridge Cancer Care | Roanoke, Virginia 24019 |
| Meritus Center For Clinical Research | Hagerstown, Maryland 21740 |
| Marin Specialty Care, Inc. | Greenbrae, California 94904 |
