Randomized, Open Label, Stratified Phase 2 Trial of Gemcitabine, Carboplatin, and Cetuximab With Vs. Without IMC-A12 in Chemotherapy-Naive Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
Participants with Stage IIIb or IV NSCLC who have not received previous chemotherapy will be
stratified, based on disease histology (squamous versus [vs.] nonsquamous).
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (ORR)
ORR is equal to the proportion of participants achieving the best overall response of confirmed partial (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
Approximately 30 weeks
No
E-mail: ClinicalTrials@ ImClone.com
Study Director
ImClone LLC
United States: Food and Drug Administration
13930
NCT00870870
March 2009
May 2012
Name | Location |
---|---|
ImClone Investigational Site | New York, New York 10021 |
ImClone Investigational Site | Bakersfield, California 93309 |
ImClone Investigational Site | Jacksonville, Florida 32207 |
ImClone Investigational Site | Atlanta, Georgia 30318 |
ImClone Investigational Site | Decatur, Illinois 62526 |
ImClone Investigational Site | Cleveland, Ohio 44134 |
ImClone Investigational Site | Birmingham, Alabama 35233 |
ImClone Investigational Site | Albuquerque, New Mexico 87131 |