drugset
drugset / Trial / NCT05673590

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

NCT05673590 ↗

Phase 3 Unknown 612 enrolled Beijing Biostar Pharmaceuticals Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Epothilone D Small molecule 40 mg/m2 Intravenous
Background Cimetidine Small molecule 300 mg Intravenous
Background Dexamethasone Small molecule 8 mg Intravenous
Background Dexamethasone Small molecule 10 mg Intravenous
Background Diphenhydramine Unknown 40 mg Intramuscular

Indications

non-small cell lung carcinoma