Randomized Open-Label Non-Comparative Multicenter Phase II Trial of Sequential Erlotinib and Docetaxel Versus Docetaxel Alone in Patients with Non-Small-cell Lung Cancer after Failure of First-Line Chemotherapy: GFPC 10.02 Study

BackgroundConcomitant administration of erlotinib with standard chemotherapy does not appear to improve survival among patients with non-small-cell lung cancer (NSCLC), but preliminary studies suggest that sequential administration might be effective.ObjectiveTo assess the efficacy and tolerability of second-line sequential administration of erlotinib and docetaxel in advanced NSCLC.MethodsIn an open-label phase II trial, patients with advanced NSCLC, EGFR wild-type or unknown, PS 0-2, in whom initial cisplatin-based chemotherapy had failed were randomized to sequential erlotinib 150mg/d (day 2–16)+docetaxel (75mg/m2 d1) (arm ED) or docetaxel (75mg/m2 d1) alone (arm D) (21-day cycle). The primary endpoint was the progression-free survival rate at 15 weeks (PFS 15). Secondary endpoints included PFS, overall survival (OS), the overall response rate (ORR) and tolerability. Based on a Simon optimal two-stage design, the ED strategy was rejected if the primary endpoint was below 33/66 patients at the end of the two Simon stages.Results147 patients were randomized (median age: 60±8 years, PS 0/1/2: 44/83/20 patients; males: 78%). The ED strategy was rejected, with only 18 of 73 patients achieving PFS15 in arm ED at the end of stage 2 and 17 of 74 patients in arm D. In arms ED and D, respectively, median PFS was 2.2 and 2.5 months and median OS was 6.5 and 8.3 months.ConclusionSequential erlotinib and docetaxel was not more effective than docetaxel alone as second-line treatment for advanced NSCLC with wild-type or unknown EGFR status.