Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

612

Participants

Timeline

Start Date

May 12, 2023

Primary Completion Date

June 15, 2025

Study Completion Date

December 31, 2025

Conditions
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Interventions
DRUG

Utidelone Injection

"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."

DRUG

Docetaxel Injection

"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."

Trial Locations (1)

Unknown

RECRUITING

Shanghai Pulmonary Hospital, Shanghai

All Listed Sponsors
lead

Beijing Biostar Pharmaceuticals Co., Ltd.

INDUSTRY