RecruitingPhase 2NCT06812871

High-dose Furmonertinib Combined With Bevacizumab and Intrathecal Pemetrexed Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Meningeal Metastasis

A Single-arm, Multicenter, Phase 2 Study of High-dose Furmonertinib Combined With Bevacizumab and Intrathecal Pemetrexed Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Meningeal Metastasis


Sponsor

Sun Yat-sen University

Enrollment

30 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

the study conducted to evaluate the efficacy and safety of high-dose furmonertinib (160 mg qd) combined with bevacizumab and pemetrexed intrathecal chemotherapy in NSCLC patients with EGFR mutations and meningeal metastases.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of high-dose furmonertinib (a targeted lung cancer drug), bevacizumab (which cuts off blood supply to tumors), and intrathecal pemetrexed (chemotherapy injected directly into the spinal fluid) for people with EGFR-mutated non-small cell lung cancer (NSCLC) that has spread to the lining of the brain (meningeal metastasis). **You may be eligible if...** - You have confirmed NSCLC with a specific EGFR mutation (exon 19 deletion, L858R, or T790M) - You have been diagnosed with meningeal metastasis, confirmed by MRI or spinal fluid analysis - You have symptoms of elevated pressure in the brain (headache, dizziness, vomiting) - This is your first diagnosis of meningeal involvement **You may NOT be eligible if...** - You do not have an EGFR mutation - You have had prior treatment that has already targeted meningeal disease - Your overall health is too poor to tolerate intrathecal chemotherapy - You have contraindications to any of the three study drugs 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

DRUGfurmonertinib

furmonertinib (160mg, once a day, continuous administration); bevacizumab (7.5 mg/kg body weight, once every 3 weeks); Pemetrexed (50 mg intrathecal injection chemotherapy, once every 3 weeks, up to 9 cycles).


Locations(1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06812871


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