Furmonertinib Combined With Anlotinib in Lung Adenocarcinoma Patients With EGFR Mutations and Brain Metastases
NCT Number: NCT06483672
Acronym: LungBrain001
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Adenocarcinoma of Lung Metastatic to Brain
Interventions: DRUG: Furmonertinib|DRUG: Anlotinib
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 27
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-12-31

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.

Primary Outcome Measures: Central Nervous System Objective Response Rate (CNS ORR), Proportion of subjects whose CNS tumors are assessed as complete response(CR) or partial response(PR) according to RANO-BM., Approximately 12 weeks after the last patient begin study treatment
Secondary Outcome Measures: Objective Response Rate (ORR), Proportion of subjects whose tumors are assessed as complete response(CR) or partial response(PR) according to RECIST 1.1., Approximately 12 weeks after the last patient begin study treatment|Disease Control Rate (DCR), Proportion of subjects whose tumors are assessed as CR, PR or stable disease (SD) according to RECIST 1.1., Approximately 12 weeks after the last patient begin study treatment|Progression Free Survival (PFS), The time from the first dose of the study drugs to the progression of the disease or death for any reason according to RECIST 1.1, Approximately 18 months after the first patient begin study treatment|Overall survival (OS), The time from the first dose of the study drugs to the death for any reason according to RECIST 1.1, Approximately 24 months after the last patient begin study treatment|Central Nervous System Disease Control Rate (CNS DCR), Proportion of subjects whose CNS tumors are assessed as CR, PR or stable disease (SD) according to RANO-BM., Approximately 12 weeks after the last patient begin study treatment|Central Nervous System Progression Free Survival (PFS), The time from the first dose of the study drugs to the progression of the CNS disease or death for any reason according to RECIST 1.1, Approximately 18 months after the first patient begin study treatment|Adverse Events (AEs), The number of patients with adverse events and the severity according to CTCAE v5.0, rom the start of study drug to 28 days after the last dose of study drug
Other Outcome Measures: Change from baseline and time to deterioration in gene mutation spectrum of ctDNA, Gene mutation spectrum of ctDNA will be detected by NGS. The development of resistance will be monitored., Approximately 18 months from the last patient begin study treatment