Phase III Randomized Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine as First-Line Chemotherapy for Stage IIIB and IV Non-Small Cell Lung Cancer
Upon determination of eligibility, patients will be randomly assigned to one of two
treatment arms:
- Paclitaxel + Carboplatin + Gemcitabine
- Gemcitabine + Vinorelbine
For ever 2 patients treated, 1 will receive treatment A (Paclitaxel + Carboplatin +
Gemcitabine) and 1 will receive treatment B (Gemcitabine + Vinorelbine). The study is not
blinded so both the patient and the doctor will know which treatment has been assigned.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival.
Anthony Greco, MD
Principal Investigator
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI LUN 54
NCT00193362
June 2004
September 2007
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