EGFR mutated NSCLC patiens with CNS metastases have poor prognosis. High-dose furmonertinib (160mg/day) have produced high CNS PFS and ORR in second-line for EGFR T790M mutated NSCLC. Whether EGFR mutated NSCLC with CNS metastases can benefit from first-line treatment of high-dose furmonertinib has not been reported. This study aims to investigate the efficacy and safety of high dose furmonertinib in first-line treatment of EGFR mutated NSCLC patiens.
This is a single arm, multicenter clinical study and will recruit about 40 EGFR mutated NSCLC patients with CNS metastases in China. Furmonertinib is a third generation Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) .The recruited patients will receive high-dose furmonertinib (160mg/day) as first-line treatment. Whether EGFR mutated NSCLC with CNS metastases can benefit from first-line treatment of high-dose furmonertinib has not been reported. This study aims to investigate the efficacy and safety of high dose furmonertinib in first-line treatment of EGFR mutated NSCLC patiens.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
furmonertinib 160 mg orally QD
Hunan Cancer hospital
Changsha, Hunan, China
RECRUITINGProgression-free survival
Progression-free survival (PFS) is defined as the time from beginning of study treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression.
Time frame: The primary analysis of Progression-free survival (PFS) based on investigator assessment will occur when PFS maturity is observed at approximately 26 months after the first patient begin study treatment
Central nervous system (CNS) progression-free survival
CNS PFS is defined as the time from beginning of study treatment until the date of objective progression of central nervous system or death (by any cause in the absence of CNS progression), regardless of whether the patient withdraws from study treatment or receives another anti-cancer therapy prior to progression.
Time frame: Central nervous system (CNS) progression-free survival (PFS) analysis based on investigator assessment will occur at approximately 26 months after the first patient begin study treatment.
Objective Response Rate
defined as the number (%) of patients with response of Complete Response or Partial Response.
Time frame: Objective Response Rate analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 26 months from the first patient begin study treatment.
Disease Control Rate
defined as the number (%) of patients with CNS lesion response of Complete Response or Partial Response.
Time frame: Disease Control Rate analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 26 months from the first patient begin study treatment.
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