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.
Signed written informed consent before any study-related procedure.
Age ≥ 18 years.
ECOG PS of 0 to 1 at screening,and with no clinically significant deterioration in the previous 2 weeks.
Expected survival ≥12 weeks.
Small cell lung carcinoma;
History of hypersensitivity to active or inactive excipients of investigational agent with a similar chemical structure.
Confirmed EGFR 20 exon insertion mutations at any time after the initial diagnosis.
Any Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI).
Single group
Furmonertinib
Drugfurmonertinib 160 mg orally QD
Progression-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.
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.
Objective Response Rate
defined as the number (%) of patients with response of Complete Response or Partial Response.
Disease Control Rate
defined as the number (%) of patients with CNS lesion response of Complete Response or Partial Response.
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