Background: Docetaxel (75 mg/m²) has been reported as first-line and maintenance treatment for Western population with advanced NSCLC. Different doses of docetaxel (60 mg/m²) are currently delivered in Asian population. Pharmacogenomics alterations in taxanes disposition in different ethnic groups may explain this difference. TFINE study was to evaluate the efficacy, safety, and tolerability of docetaxel in the maintenance setting, and to identify the preferable dose of docetaxel in Asian population. Methods: Previously untreated patients, aged between 18 and 75 years, histologically or cytologically confirmed advanced NSCLC with PS of 0-1 were included. Patients were initially randomized (R1, 1:1) to receive cisplatin (75 mg/m²) plus docetaxel of 75 mg/m² or 60 mg/m² for 4 cycles. Patients with disease control after the initial treatment were subsequently randomized (R2, 1:2) to best supportive care (BSC) or maintenance docetaxel of 60 mg/m² for up to 6 cycles. Genomic DNA was prospectively collected from all enrolled patients. The primary endpoint was PFS since R2, and the secondary endpoints included ORR, overall survival, and toxicity. This study is registered with ClinicalTrials.gov (NCT01038661). Results: This randomized study was undertaken in 15 centers in China. A total of 378 patients were enrolled to R1 and 184 patients (48.7%) were enrolled to R2 (61 vs. 123). Maintenance docetaxel plus BSC significantly prolonged PFS compared with BSC (5.4 months [95% CI 2.8, 7.0] vs. 2.8 months [1.8, 3.1]; P=0.002). The difference of ORR during initial chemotherapy was not significant, with 32.4% in the 60 mg-group and 33.7% in 75 mg-group (P=0.80).The data concerning the overall survival and toxicity, together with the information of pharmacogenomics alterations, will be presented in the meeting subsequently. Conclusions: Maintenance therapy with docetaxel is well tolerated and offers improved PFS in patients with advanced NSCLC.The dose of 60 mg/m² of docetaxel demonstrated similar efficacy and better tolerability than that of 75 mg/m² and should be preferred in Asian population. Clinical trial information: NCT01038661.