PURPOSE: In a large multicenter international phase III study (CA031) of nab-paclitaxel (nab-P, 130nm albumin-bound paclitaxel particles)+carboplatin (C) vs solvent-based paclitaxel (sb-P)+C, conducted in 6 countries including Japan, nab-PC produced significantly higher overall response rate (ORR), primary end point compared with sb-PC, and acceptable safety profile. The aim of this analysis was to evaluate the efficacy and tolerability of nab-PC vs sb-PC in Japanese patients with advanced non-small-cell lung cancer (NSCLC) who were enrolled in the CA031 study. PATIENTS AND METHODS: In the CA031 study, a total of 1052 patients were randomized to receive either nab-P 100mg/m(2) weekly or sb-P 200mg/m(2) every 3 weeks both in combination with C at area under the concentration-time curve (AUC)=6 on day 1 of each 3-week cycle. This analysis included 149 Japanese patients with previously untreated stage IIIB or IV NSCLC. RESULTS: The baseline and histologic characteristics of patients were well balanced between the two arms. ORR was higher with nab-PC vs sb-PC (35% vs 27%; response rate ratio=1.318). Progression-free survival (median 6.9 vs 5.6 months; hazard ratio [HR]=0.845) and overall survival (median 16.7 vs 15.9 months; HR=0.930) were better with nab-PC vs sb-PC. Of the grade ≥3 treatment-related adverse events, anemia and thrombocytopenia were more common in nab-PC arm, but sensory neuropathy was less common. CONCLUSION: The nab-PC treatment yielded promising results regarding the efficacy endpoint, and it was generally well tolerated as first-line therapy for Japanese patients with advanced NSCLC.