A Phase II Trial of Carboplatin Plus Cetuximab for the Treatment of Stage IIIb/IV Non-Small Cell Lung Cancer
Lung cancer is the second most common cancer diagnosed for both genders in the United
States. Approximately 173,770 new cases are estimated for 2004. It is the leading cause of
cancer deaths in both men and women, with approximately 160,440 deaths estimated for 2004.
Prognosis for many is poor if not diagnosed at an early stage, and therapy for advanced
disease is limited. The study will test carboplatin in combination with a newly approved
drug called cetuximab, which is continuing to be tested in colorectal cancer and other
cancers. Cetuximab is a monoclonal antibody, which is believed to work by attaching to an
epidermal growth factor receptor (EGFR) on tumor cells and thereby blocking tumor cells from
reproducing. It is an antibody to the EGFR. Fifty percent of lung cancers overexpress EGFR.
The present study is built upon the data from the described studies, incorporating cetuximab
into a regimen of single-agent carboplatin. Previous data suggest that single agent
carboplatin is active in NSCLC. The addition of biologic therapy with the anti-EGFR agent
cetuximab to carboplatin will presumably maximize the therapeutic index while keeping
toxicity to a minimum in patients with Stage IIIB/IV NSCLC.
The population being studied in this trial is subjects with previously untreated Stage IIIB
or IV NSCLC. The research hypothesis is that these subjects will achieve a response (based
on RECIST criteria) to therapy with the combination of carboplatin and cetuximab.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the overall response rate
Every six months
E-mail: ClinicalTrials@ ImClone.com
United States: Food and Drug Administration
|ImClone Investigational Site||Atlanta, Georgia 30318|
|ImClone Investigational Site||Decatur, Illinois 62526|
|ImClone Investigational Site||Louisville, Kentucky 40202|
|ImClone Investigational Site||Little Rock, Arkansas 72205|
|ImClone Investigational Site||Winston-Salem, North Carolina 27103|
|ImClone Investigational Site||Philadelphia, Pennsylvania 19107|