Docetaxel + ramucirumab (DR) versus docetaxel + placebo (D) as second-line treatment for advanced non-small cell lung cancer (NSCLC): A randomized, phase II, double-blind, multicenter trial in Japan.

8054 Background: A randomized global phase III trial (REVEL) demonstrated statistically significant improvement in OS and PFS for DR versus D in patients (pts) with advanced NSCLC; a limited number of East Asian pts were given docetaxel (DOC) at 75 mg/m2, higher than 60 mg/m2recommended in Japan. Methods: A similar phase II study was conducted in Japan to evaluate the efficacy of DR for stage IV NSCLC following disease progression during or after prior platinum-based chemotherapy. Pts with EGFR mutant NSCLC who received prior EGFR tyrosine kinase inhibitor (TKI) therapy were enrolled as exploratory. Eligibility criteria included ECOG PS 0-1, age ≥ 20 years, and adequate organ function. Pts were randomized 1:1 to receive DOC 60 mg/m2+ramucirumab 10 mg/kg IV or placebo on Day 1 of a 21-day cycle until disease progression. Stratification factors: PS, gender, prior maintenance therapy. The primary endpoint was PFS to be analyzed after observing 134 PFS events for pts without prior EGFR-TKI therapy (primary po...