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

Sponsor
Beijing Biostar Pharmaceuticals Co., Ltd.
Study ID
NCT06683703
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Non-small Cell Lung Cancer Patients with Brain Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Utidelone combined with Bevacizumab — DRUG
    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).
  • Utidelone — DRUG
    Utidelone injection, 30mg/m2/d, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle
  • Utidelone combined with Bevacizumab — DRUG
    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.
  • Utidelone combined with Bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Nov 12, 2024
Start date
Dec 1, 2024
Status verified
Nov 2024
Primary completion
Dec 1, 2026
Completion
Dec 1, 2027

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Stage 1 Safety run-in
    Utidelone + Bevacizumab
  • Experimental: Stage 1 Extension: Monotherapy group
    Utidelone
  • Experimental: Stage 1 Extension: Combined treatment group
    Utidelone+ Bevacizumab
  • Experimental: Stage 2
    Utidelone + Bevacizumab

Primary Outcome Measure

Intracranial objective response rate (iORR) according to the RECIST 1.1. [ Time Frame: Time Frame: 18 months ]

Central Contacts