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.
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 Type
OBSERVATIONAL
Enrollment
30
Patients treated with Furmonertinib mesilate tablets orally
Tangdu Hopspital
Xi’an, Shanxi, China
RECRUITINGIntracranial Objective response rate
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with CNS lesion response of Complete Response or Partial Response, will be assessed up to 2 years.
Time frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 2 years.
Intracranial Disease Control Rate
The percentage of subjects who have a best CNS lesion response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by the Investigator, will be assessed up to 2 years.
Time frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 2 years.
Intracranial progression-free survival
Intracranial progression-free survival (PFS) analysis based on investigator assessment and will be assessed up to 3 years.
Time frame: Intracranial progression-free survival (PFS) analysis based on investigator assessment and will be assessed up to 3 years.
Progression-free survival
Progression-free survival (PFS) is defined as the time from first dose of Furmonertinib recorded until the date of disease progression based on investigator assessment.
Time frame: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years.
Overall Survival
Overall survival is defined as the time from beginning of furmonertinib treatment until death due to any cause and will be assessed up to 3 years.
Time frame: The time from beginning of furmonertinib treatment until death due to any cause and will be assessed up to 3 years.
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Safety/Adverse event
Incidence of Adverse Events (AEs): Incidence, severity and seriousness of adverse events, incidence of serious adverse events (SAEs), which usually be graded by CTCAE v5.0 based on current clinical practice.
Time frame: From the recorded first dose of Furmonertinib to 4 weeks after the recorded last dose of Furmonertinib