NCT06483672

Furmonertinib Combined With Anlotinib in Lung Adenocarcinoma Patients With EGFR Mutations and Brain Metastases

Furmonertinib Combined With Anlotinib in Lung Adenocarcinoma Patients With EGFR Mutations and Brain Metastases, a Prospective Phase II Single-arm Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if furmonertinib plus anlotinib works to treat participants with lung adenocarcinoma with EGFR mutations and brain metastases. It will also learn about the safety of furmonertinib plus anlotinib. The main questions it aims to answer are: * Does furmonertinib plus anlotinib increase the number of participants who has a significant tumor shrinkage? * What medical problems do participants have when taking furmonertinib plus anlotinib? Researchers will evaluate the safety and efficacy of furmonertinib plus anlotinib. Participants will: * Take furmonertinib(every day) and anlotinib(two weeks on and one week off) * Visit the clinic once every 3 weeks for checkups and tests. * Keep a diary of their symptoms.

Detailed description

The objective of this study is to explore the effectiveness and safety of furmonertinib and anlotinib as first-line treatment for patients with EGFR mutation and brain metastasis lung adenocarcinoma. This clinical trial adopts a single-center, prospective, single-arm phase II trial design. Each 3 weeks constitute a treatment cycle until disease progression or intolerance. After screening, eligible patients will be enrolled in the study. They will receive furmonertinib and anlotinib as first-line treatment. The patients will undergo regular visits, and researchers will collect data on efficacy and safety.

Conditions

• Adenocarcinoma of Lung Metastatic to Brain

Interventions

Type	Name	Description
DRUG	Furmonertinib	Furmonertinib 80mg, once daily, orally
DRUG	Anlotinib	Anlotinib 12mg, once daily (days 1-14, 21 days per cycle), orally

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2024-07-03
• Last updated: 2024-07-03