RecruitingPhase 2NCT05379803

High-dose Furmonertinib for First-line Treatment of EGFR Mutated NSCLC With Central Nervous System (CNS) Metastases

A Single Arm, Multicenter Clinical Study of High-dose Furmonertinib in First-line Treatment of EGFR Mutated NSCLC With Central Nervous System (CNS) Metastases


Sponsor

Hunan Province Tumor Hospital

Enrollment

40 participants

Start Date

May 1, 2022

Study Type

INTERVENTIONAL

Summary

EGFR mutated NSCLC patiens with CNS metastases have poor prognosis. High-dose furmonertinib (160mg/day) have produced high CNS PFS and ORR in second-line for EGFR T790M mutated NSCLC. Whether EGFR mutated NSCLC with CNS metastases can benefit from first-line treatment of high-dose furmonertinib has not been reported. This study aims to investigate the efficacy and safety of high dose furmonertinib in first-line treatment of EGFR mutated NSCLC patiens.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a higher-than-standard dose of a targeted lung cancer drug called furmonertinib (an EGFR inhibitor) works better for patients with non-small cell lung cancer that has spread to the brain, compared to the standard dose. **You may be eligible if...** - You are 18 or older with confirmed metastatic non-small cell lung cancer (NSCLC) - Your cancer has a specific genetic mutation in the EGFR gene (called 19del or L858R) - You have at least one measurable tumor in the brain - You are in good overall health (ECOG 0–1) with a life expectancy of at least 12 weeks - You have not previously received treatment with an EGFR-targeting drug **You may NOT be eligible if...** - Your tumor does not have the EGFR 19del or L858R mutation - You have already been treated with an EGFR inhibitor - You have significant heart or other organ function problems 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 160 mg orally QD


Locations(1)

Hunan Cancer hospital

Changsha, Hunan, China

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NCT05379803