Spots Global Cancer Trial Database for Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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Trial Identification

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

Official Title: 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

Study ID: NCT05673590

Conditions

Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Interventions

Utidelone Injection

Docetaxel Injection

Study Description

Brief 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.

Detailed Description: In this study, 612 patients will be screened, enrolled and randomly assigned in a 1:1 ratio to either the Utidelone (40 mg/m2/d intravenously once daily on days 1-5) treatment or the docetaxel (75 mg/m2/d, intravenously once on day 1) control group, stratified by prior immunotherapy status (PD-1/PD-L1 vs. no PD-1/PD-L1). Both groups will be treated in a 21-day cycle until disease progression or an occurrence of intolerable toxicities. Tumor assessments will be performed at baseline and every 6 weeks (±7 days) after randomization and continued until disease progression as assessed by RECIST v1.1 criteria, with or without discontinuation of study treatment; the EORTC QLQ-C30 questionnaire will be used to assess patients' quality of life based on a signed informed consent.