NCT06683703

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

Phase II Clinical Trial on the Efficacy and Safety of Utidelone Combined with Bevacizumab in Patients with Non-small Cell Lung Cancer with Brain Metastases.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with non-small cell lung cancer and brain metastases were enrolled in this study. The first stage consisted of a safety run-in (combination group only) and an expansion. During the safety run-in phase, a 3+3 dose step-down design was used, starting with 30mg/m2/d of Utidelone,D1-D5,Q3W plus Bevacizumab 15mg/kg/Q3w. The dose of Utidelone was reduced by up to one dose (to 25mg per square meter), and the dose of Bevacizumab was unchanged (15mg/kg/Q3w). We planned to enroll 3 to 12 patients in the safety run-in. In the extension, the patients were randomly assigned to the combination group and the monotherapy group (hereinafter referred to as the monotherapy group). 30 patients were planned to be enrolled in the monotherapy group, and 24 or 27 patients were enrolled in the combination group according to the safety run-in. The second stage of dosing was the same as the first stage of expansion in the combination-therapy group, and the results of the first stage determined whether to proceed to the second stage. If second stage was reached, an additional 52 patients would be enrolled.

Conditions

• Non-small Cell Lung Cancer Patients with Brain Metastases

Interventions

Type	Name	Description
DRUG	Utidelone combined with Bevacizumab	The initial dose was Utidelone 30mg/m2/d,D1-D5,Q3W+ Bevacizumab 15mg/kg/Q3w. If dose adjustment was required due to DLT events, Utidelone was reduced by up to one dose (to 25mg/m2/d), while the dose of Bevacizumab remained unchanged (15mg/kg).
DRUG	Utidelone	Utidelone injection, 30mg/m2/d, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle
DRUG	Utidelone combined with Bevacizumab	In the combination group, the dose of Utidelone was determined according to the safety run-in period, 30 mg/m2/d or 25mg/m2/d, D1-D5,Q3W; The dose of Bevacizumab was 15 mg/kg/3W.
DRUG	Utidelone combined with Bevacizumab	The dose of Utidelone was 30 mg/m2/d or 25mg/m2/d, D1-D5,Q3W; The dose of Bevacizumab was 15 mg/kg/3w.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2024-11-12
• Last updated: 2024-11-12