Study of Furmonertinib with Anlotinib as First Treatment for Advanced NSCLC Patients with EGFR Mutations and Brain Metastases

What this Trial Is About

This research aims to evaluate the safety and effectiveness of combining Furmonertinib with Anlotinib as a first treatment option for patients with advanced non-small cell lung cancer NSCLC who have EGFR-sensitive mutations and brain metastases. Patients with EGFR mutation-positive NSCLC have an increased risk of brain metastases, which often lead to a poor prognosis. Furmonertinib is a new EGFR tyrosine kinase inhibitor TKI with enhanced brain penetration, supported by preclinical studies, and combining it with antiangiogenic agents like Anlotinib may improve treatment outcomes by jointly inhibiting tumor growth and spread. Participants will receive Furmonertinib at a dose of 160 mg once daily and Anlotinib at 8 mg daily taken orally for 14 days in each 21-day treatment cycle. This study is a single-arm, multi-center, phase 2 trial that includes an initial safety phase lasting up to 6 months, followed by a formal research phase lasting up to 42 months to assess treatment efficacy and safety over time. During the study, participants will undergo regular assessments including brain imaging with CT or MRI to confirm brain metastases and measurable tumor lesions. Researchers will monitor safety, progression-free survival, response rates, disease control, and duration of response, including specific evaluations of central nervous system effectiveness. The study will also track participants overall health and organ function, with safety evaluations continuing throughout the treatment period up to 42 months.

A Clinical Trial of Furmonertinib Combined With Anlotinib as First-line Treatment for Advanced NSCLC With EGFR-sensitive Mutations and Brain Metastasis