Evaluation of the Efficacy and Safety of Furmonertinib Combined with Bevacizumab As First-Line Treatment for EGFR-Positive Non-Small Cell Lung Cancer with Brain Metastases: a Single-Arm, Open-Label, Prospective Phase II Clinical Study

Sponsor
Li-kun Chen
Study ID
NCT06728865
Phase
PHASE2
Status
Recruiting
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Conditions

  • Brain Metastases
  • EGFR Mutation-Positive Lung Cancer
  • Intracranial Tumor Progression
  • Leptomeningeal Metastases
  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
15 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study evaluates the safety and efficacy of Befotertinib combined with Bevacizumab as a first-line treatment for patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC) accompanied by brain or leptomeningeal metastases. It is a single-arm, open-label, prospective Phase II clinical trial aiming to explore the potential benefits of this combination therapy in improving intracranial progression-free survival (iPFS) and overall survival (OS). Patients will receive Befotertinib daily and Bevacizumab every three weeks until disease progression, intolerable toxicity, or withdrawal of consent. The study seeks to address the unmet need for effective treatments in this challenging patient population.

Key Dates

Start date
Sep 4, 2024
Status verified
Nov 2024
Primary completion
Feb 1, 2028
Completion
Feb 1, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Furmonertinib Combined with Bevacizumab Treatment Group
    The treatment regimen is Furmonertinib combined with Bevacizumab.

Primary Outcome Measure

12-Month Intracranial Progression-Free Survival Rate Assessed by RECIST 1.1 in Patients with EGFR-Mutant NSCLC and Brain Metastases [ Time Frame: 12 months from the initiation of treatment ]

Central Contacts

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