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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Furmonertinib 80mg, once daily, orally
Anlotinib 12mg, once daily (days 1-14, 21 days per cycle), orally
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.
Time frame: Approximately 12 weeks after the last patient begin study treatment
Objective Response Rate (ORR)
Proportion of subjects whose tumors are assessed as complete response(CR) or partial response(PR) according to RECIST 1.1.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: rom the start of study drug to 28 days after the last dose of study drug
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