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An Observational Study of Furmonertinib for EGFR Mutation-positive NSCLC Patients With Brain Metastasis

EGF-R Positive Non-Small Cell Lung Cancer Clinical Trial

Official title:
Efficacy and Safety of Furmonertinib for Epidermal Growth Factor Receptor (EGFR) Sensitive Mutation Positive Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis: a Prospective Observational Study

Clinical Trial Summary

EGFR mutation positive advanced NSCLC patients with CNS metastases were associated with poor prognosis. Furmonertinib showed promising CNS efficacy in doses of 80 mg orally once daily or higher in patients with EGFR T790M mutation positive NSCLC. This study aims to investigate the efficacy and safety of furmonertinib in the treatment of EGFR-sensitive mutation positive NSCLC patients with brain metastasis.

Clinical Trial Description

This study aims to prospectively observe the efficacy and safety of furmonertinib in the treatment of EGFR-sensitive mutation positive NSCLC patients with brain metastasis and will recruit about 30 patients in China. Furmonertinib (AST2818) is a brain penetrant third generation EGFR TKI. In preclinical studies, the concentration of furmonertinib and its main active metabolite in the brain was higher than that in the plasma, indicating that furmonertinib had the potential to treat CNS metastases. Furmonertinib showed promising CNS efficacy in doses of 80 mg orally once daily in patients with EGFR T790M mutated NSCLC, the median CNS PFS was 11.6 months and 19.3 months in the 80 mg and 160 mg orally once daily group, and the CNS ORR was 65% and 85% in the 80 mg and 160 mg group. This study will enroll the EGFR-sensitive mutation positive NSCLC patients with brain metastasis who are treated by furmonertinib, and the efficacy and safety data will be recorded. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06352502
Study type Observational
Source Tang-Du Hospital
Contact Haichuan Su, PhD
Phone 18629190366
Email such@fmmu.edu.cn
Status Recruiting
Phase
Start date January 28, 2022
Completion date September 30, 2024
View Details
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