RecruitingPhase 2NCT06728865

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

Enrollment

70 participants

Start Date

Sep 4, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 15 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase II study is testing a combination of furmonertinib (a targeted lung cancer drug) and bevacizumab (an anti-blood vessel drug) as first-line treatment for people with EGFR-mutated non-small cell lung cancer that has spread to the brain. **You may be eligible if...** - You are 18 to 75 years old in reasonably good health (ECOG 0-2) - You have confirmed non-squamous NSCLC with a specific EGFR mutation (19del or L858R) - You have brain metastases that are either asymptomatic or have controlled symptoms - You have at least one brain lesion of at least 5mm visible on MRI - You have not received prior systemic treatment for advanced or metastatic NSCLC - Your blood counts, kidney, liver, and heart function meet required levels **You may NOT be eligible if...** - You have active bleeding in the brain or leptomeningeal disease with active bleeding - You previously received bevacizumab or similar anti-VEGF drugs - You have had prior whole-brain radiation - You have poorly controlled high blood pressure, heart problems, or serious bleeding history - You have active hepatitis, HIV, or active tuberculosis - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGThe treatment regimen is Furmonertinib combined with Bevacizumab.

The treatment regimen is Furmonertinib combined with Bevacizumab.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06728865


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