A Phase III, Open-label, Randomized, Controlled Clinical Study of Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Previously Failed Platinum-containing Chemotherapy Regimens

Pretreatment: diphenhydramine 40 mg by intramuscular injection or oral administration, and dexamethasone10 mg and cimetidine 300 mg by intravenous injection 30 minutes prior to Utidelone iv drip at the first day of each cycle. The dose of dexamethasone and diphenhydramine can be halved by the physician based on patient's condition in the following day through the fifth day in each cycle, as detailed in the protocol. Dexamethasone 8 mg per oral, bid, one day prior to docetaxel iv drip for 3 days. The treatment group will be treated with Utidelone Injection at 40 mg/m2/d intravenously once daily on days 1-5 in a 21-day cycle until disease progression or an occurrence of intolerable toxicities.

Pretreatment: Dexamethasone should be administered orally for 3 days at 16 mg per day (8 mg twice daily), starting one day before the start of Docetaxel. The control group will be treated with Docetaxel Injection at 75 mg/m2/d, administered intravenously once on day 1. Patients in this group will be treated in 21-day cycles until disease progression or intolerable toxicities occurs.