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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer - Non Small Cell

Thank you

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, LLCGalesburg, Illinois  61401
Carolina BioOncology InstituteHuntersville, North Carolina  28078
Montgomery Cancer CenterMt. Sterling, Kentucky  40353
Quincy Medical GroupQuincy, Illinois  62301
Blue Ridge Cancer CareRoanoke, Virginia  24019
Meritus Center For Clinical ResearchHagerstown, Maryland  21740
Marin Specialty Care, Inc.Greenbrae, California  94904