A Phase 2, Open-label Study of IMC-1121B in Combination With Paclitaxel and Carboplatin as First-line Therapy in Patients With Stage IIIB/IV Non-small Cell Lung Cancer
Non-small cell lung cancer (NSCLC) accounts for 75-80% of all lung cancers; and the advanced
stages are associated with poor survival rates with untreated patients having a median
survival rate of approximately 3.9 months.
Angiogenesis is a process that occurs in the health body for wound healing and restoring
blood flow to tissues after injury. It is the physiological proves involving the growth of
new blood vessels from pre-existing vessels. Angiogenesis may be promoted by growth factors
and in diseases such as cancer, where growth factors are over expressed, the body loses the
ability to maintain a balanced angiogenesis. This may embellish the existing supplies of
blood; potentially increasing the delivery of oxygen and nutrients supplies for cancer
growth and survival.
ramucirumab is an angiogenesis inhibitor; and is believed to block the promotion of the
growth factor to forming new blood vessels, thus reducing the amount of blood supplies to
the cancer cells.
In this study, 40 adult patients with NSCLC will be evaluated t=for progression-free
survival at 6 months of ramucirumab administration
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of Participants Who are Progression-free (PFS) at 6 months
The 6-month progression-free survival (PFS) rate is defined as the proportion of participants that are alive and progression-free 6 months after randomization.
6 months
No
E-mail: ClinicalTrials@ ImClone.com
Study Director
ImClone LLC
United States: Food and Drug Administration
13914
NCT00735696
January 2009
January 2012
Name | Location |
---|---|
ImClone Investigational Site | Denver, Colorado 80262 |
ImClone Investigational Site | New York, New York 10021 |
ImClone Investigational Site | Bakersfield, California 93309 |
ImClone Investigational Site | Dallas, Texas 75230 |
ImClone Investigational Site | Seattle, Washington 98104 |