drugset / Trial / NCT06683703

Utidelone Injection Combined with Bevacizumab Injection for Non-small Cell Lung Cancer Patients with Brain Metastases

NCT06683703

Phase 2 Not yet recruiting 118 enrolled Beijing Biostar Pharmaceuticals Co., Ltd.
RandomizedFactorialOpen-labelTreatment

Summary

This study is a prospective, multicenter, two-stage phase II clinical trial evaluating the efficacy and safety of Utidelone combined with Bevacizumab in patients with non-small cell lung cancer with brain metastases. The main objective of the first stage was to determine the combined dose of the first stage and the second stage, and to compare the intracranial efficacy of the two treatment groups. Secondary objectives were to compare other intracranial efficacy, systemic efficacy, safety and tolerability between the two treatment groups.In the second stage, the main purpose was to evaluate the intracranial efficacy of Utidelone combined with Bevacizumab in patients, and the secondary purpose was to evaluate the other intracranial efficacy, systemic efficacy, safety and tolerability of Utidelone combined with Bevacizumab in patients, and to explore the improvement of patients' quality of life.

Timeline

Start
2024-12-01
Primary completion
2026-12-01
Completion
2027-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 15 mg/kg
Subject Epothilone D Small molecule 25 mg/m2
Subject Epothilone D Small molecule 30 mg/m2