Phase I/II study of biweekly nab-paclitaxel in patients with platinum-pretreated non-small cell lung cancer: NJLCG1402

Background NJLCG1402 was a phase I/II trial investigating biweekly nanoparticle albumin-bound paclitaxel (nab-PTX) in patients with advanced non-small cell lung cancer (NSCLC). Methods The study included patients aged >= 20 years with previously treated NSCLC. Nab-PTX (100-150 mg/m(2)) was administered biweekly in a 28-day cycle. The phase I portion was performed to determine the recommended phase II dose of nab-PTX. In the phase II portion, the primary endpoint was the objective response rate. Secondary endpoints were disease control rate, progression-free survival, overall survival, and safety. Results A total of 15 patients received biweekly nab-PTX (100-150 mg/m(2)) and 12 patients in phase II were treated with 150 mg/m(2). In the phase I portion, 150 mg/m(2) was determined as the recommended dose. Among those treated with 150 mg/m(2), the objective response rate was 22%, and the median progression-free and overall survival was 3.6 and 11.2 months, respectively. Adverse events grade >= 3 were observed in 39% of patients. Conclusions Biweekly nab-PTX monotherapy was well tolerated and exhibited favorable antitumor activity in patients with previously treated NSCLC.