Dalian Wanchun Biotechnology Co., Ltd.

Primary objective: Based on the Phase I/II clinical trial in the United States, confirm the tolerability and pharmacokinetic characteristics of Plinabulin combined with docetaxel in the treatment of Chinese patients with advanced non-small cell lung cancer, and explain the rationality of RP3D in the Chinese population of the BPI-2358-103 trial. Secondary objective: To evaluate the preliminary pharmacodynamic response (tumor efficacy, prevention of leukopenia) and safety of Plinabulin combined with docetaxel in the treatment of patients with advanced non-small cell lung cancer.

To compare the overall survival, neutropenia, DOR, quality of life, RR, and PFS of patients with advanced or metastatic NSCLC treated with docetaxel + plinabulin (DP group) and docetaxel + placebo (D group) as second-line or third-line chemotherapy. To compare the safety and adverse event profiles of DP and D, as well as docetaxel administration delays, dose adjustments, and/or dose discontinuations due to safety issues in the two treatment groups. To evaluate the population pharmacokinetics in subjects in China and Western countries.