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 population). The number was designed to show a high likelihood of observing PFS HR < 1. Secondary endpoints: safety profile, OS, objective response rate (ORR), disease control rate (DCR), patient-reported outcomes. We report the results of the primary population. Results: 157 pts (DR 76; D 81) were randomized and treated. Pts characteristics were balanced between arms. The median PFS was 5.2 months (m) [95%CI 3.52, 6.97] for DR and 4.2m [2.83, 5.62] for D; hazard ratio (HR) 0.83 [0.59, 1.16]. ORR: 28.9% (DR), 18.5% (D). DCR: 78.9% (DR), 70.4% (D). The median OS at the time of primary PFS analysis was 15.2m for DR and 14.0m for D (data are immature). Main Grade3/4 toxicites (DR vs D) were neutropenia (90% vs 86%), leukopenia (70% vs 68%), febrile neutropenia (33% vs 20%) and anorexia (7% vs 5%). The Grade3/4 febrile neutropenia did not lead to any fatal events and incidence of Grade ≥ 3 infections were 1% vs 10%. Conclusions: Efficacy results were consistent with those from REVEL. DR has shown clinical benefit over D in terms of PFS, ORR, and DCR in Japanese NSCLC pts. DR was well tolerated, with manageable toxicity. Clinical trial info: NCT01703091. Clinical trial information: NCT01703091