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
NCT06728865 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2024-12-11
Summary
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.
Conditions
- Non-small Cell Lung Cancer (NSCLC)
- EGFR Mutation-Positive Lung Cancer
- Brain Metastases
- Leptomeningeal Metastases
- Intracranial Tumor Progression
Interventions
- DRUG
-
The treatment regimen is Furmonertinib combined with Bevacizumab.
The treatment regimen is Furmonertinib combined with Bevacizumab.
Sponsors & Collaborators
-
Li-kun Chen
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 15 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-04
- Primary Completion
- 2028-02-01
- Completion
- 2028-02-01
Countries
- China
Study Locations
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