Efficacy and safety results from CurrentS, a double-blind, randomized, phase III study of second-line erlotinib (150 mg versus 300 mg) in current smokers with advanced non-small cell lung cancer (NSCLC).

8046 Background: Pts with NSCLC who are active smokers may have increased erlotinib metabolism v non-smokers, which reduces exposure. Methods: Pts with stage IIIB/IV NSCLC (failed first-line platinum-based chemotherapy, current smokers) were randomized to receive standard dose erlotinib (150 mg/day; E150) or an experimental dose (300 mg/day; E300) until progression/death/unacceptable toxicity. Pts were assessed every 6 wks. Primary endpoint: progression-free survival (PFS). Secondary endpoints included: overall survival (OS), disease control rate (DCR), and safety. Planned sample size: 300 randomized pts; 277 PFS events needed to show a HR of 0.714 (median PFS improvement from 10 to 14 wks; E300 was expected to provide a longer median PFS v E150) with 80% power (5% 2-sided α). Results: Baseline characteristics were balanced (Table). Efficacy and safety results are reported (Table). Conclusions: CurrentS, the first and largest trial in active smokers with NSCLC to date, did not show a statistically signifi...