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

NCT05673590 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 612

Last updated 2023-11-08

No results posted yet for this study

Summary

The purpose of this clinical trial is to compare Utidelone with Docetaxel in patients with locally advanced or metastatic non-small cell lung cancer previously failed platinum-containing chemotherapy regimens. This phase III, open-label, randomized controlled trial aims to evaluate and compare the efficacy and safety of Utidelone and Docetaxel in the aforementioned lung cancers.

Conditions

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.

Sponsors & Collaborators

  • Beijing Biostar Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Caicun Zhou, MD · Shanghai Pulmonary Hospital, Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-12
Primary Completion
2025-06-15
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05673590 on ClinicalTrials.gov