Randomized phase III trial of erlotinib vs. docetaxel in patients with advanced squamous cell non-small cell lung cancer (SqNSCLC) failing first line platinum based doublet chemotherapy stratified by VeriStrat Good vs VeriStrat Poor: The European Thoracic Oncology Platform (ETOP) EMPHASIS trial.

8049 Background: Docetaxel (D) or Erlotinib (E) are registered second-line treatments for EGFR wild type NSCLC. Previous studies suggested a predictive value of the serum proteomic VeriStrat test (VS), assigning a good (VSG) or poor (VSP) classification in second-line therapy of patients (pts.) with NSCLC. EMPHASIS aimed at exploring a predictive interaction in SqNSCLC pts. The trial closed prematurely due to low accrual. Methods: EMPHASIS is a randomized phase III multicenter trial exploring the differential activity of second line E vs D on progression-free survival (PFS) in VSG vs VSP SqNSCLC. The expected hazard ratio (HR) of E vs D was 0.675 for the VSG patients (median PFS, E: 4.0 and D: 2.7 mo.), and 1.23 for the VSP patients (median PFS, E: 2.2 and D: 2.7 mo.). A sample size of 500 was needed to achieve 86% power for testing the expected interaction HR of 1.82 at a two-sided p-value of 0.05. Pts were randomized to receive treatment E150 mg p.o. daily or D 75 mg/m2 i.v. on day 1 of each 21 day cycl...