Randomized study of vinorelbine–gemcitabine versus vinorelbine–carboplatin in patients with advanced non-small cell lung cancer

Summary Purpose: The objective of this trial was to compare two vinorelbine-based doublets with carboplatin (CBDCA-VC) or with gemcitabine (VG) in patients with stage IIIB—IV non-small cell lung cancer (NSCLC). Patients and Methods: A total of 316 patients with advanced NSCLC previously untreated were randomized to either vinorelbine 30 mg/m 2 D1,8 with carboplatin AUC 5 D1 (VC) or vinorelbine 25 mg/m 2 with gemcitabine (VG) 1000 mg/m 2 both given D1,8 every 3 weeks. The primary endpoint was response rate with secondary parameters being survival (OS), progression-free survival (PFS), tolerance and clinical benefit.