A Phase III Randomized Trial of Gemcitabine/Oxaliplatin (GEMOX) Versus Carboplatin/Paclitaxel (CP) as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Date de début de l'étude : 1 mars 2004

Inclusion Criteria: * Newly diagnosed, Stage IIIb or IV NSCLC, chemo or other systemic therapy naive * One (1) unidimensionally measurable lesion * ECOG Performance Status of 0 or 1, no peripheral neuropathy \>Grade 1 * Patients with clinically stable brain metastases on a stable dose of (or no longer requiring) dexamethasone at registration will be eligible. Patients who have received cranial radiation for brain metastases must be at least 4 weeks from last radiation treatment. * Recovery in full from any previous surgical procedure * No history of an acute cardiac or CNS event within 6 months of entry or current clinical evidence of congestive heart failure or non-stable coronary artery disease Exclusion Criteria: * Hypersensitivity to any of the 4 study drugs * Concurrent immunotherapy or participation in any investigational drug study within 4 weeks * Serious uncontrolled intercurrent medical or psychiatric illness and organ allograft * History of other malignancy within the last 5 years (except for squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder) * Patient is a pregnant or lactating female