8083 Background: The FLEX trial demonstrated superior survival for cisplatin/vinorelbine plus cetuximab versus cisplatin/vinorelbine alone in patients with advanced EGFR-positive NSCLC. Here we report on the prognostic factors observed in the trial independent of cetuximab treatmentMethods: 1125 patients were randomized to cisplatin/vinorelbine plus cetuximab or cisplatin/vinorelbine alone. Prognostic factors were determined by both univariate and multivariate analyses. Results: Patient baseline characteristics were: 70% male, median age 59 (18–83) years, 31% older than 65 years, 94% stage IV, 47% adenocarcinoma, 34% squamous cell carcinoma, 83% ECOG 0/1. The trial confirmed the following prognostic factors in the univariate analysis: gender, performance status, histology, smoking status, and ethnicity. Females had longer survival than males (12.7 versus 9.3 months). Patients with ECOG performance status 0, 1, and 2 had median survival times of 13.5, 10.6 and 5.9 months, respectively. Patients with adenocarcinomas had a median survival of 12.4 months and those with squamous cell carcinomas had a median survival of 9.3 months. Smokers, former smokers, and never-smokers had median survival times of 9.0, 11.1 and 14.6 months, respectively. Outcome was better for Asians (n=121) compared to Caucasians (n=946) (median 19.5 versus 9.6 months). Age <65 and age ≥65 did not indicate prognosis. Multivariate analysis confirmed the prognostic significance of performance status, gender, smoking status, region (Europe versus Australasia), and histology. Conclusions: The FLEX trial confirmed several prognostic factors, including gender, performance status, histological subtype, ethnicity, and smoking status for patients with advanced NSCLC. [Table: see text]