Furmonertinib, a newly-designed pan-EGFR-TKI with a trifluoroethoxypyridine-based molecule structure, has shown promising clinical efficacy in EGFR Ex19del/L858R/T790M/Ex20ins mutant advanced NSCLC with an acceptable safety profile without new signals from 80mg to 240mg dose level in phase 1-3 clinical trials. Whether EGFR G719X/S768I/L861Q mutation positive advanced NSCLC patients can benefit from first-line furmonertinib 160mg per day has not been reported. This study aims to investigate the efficacy and safety of furmonertinib 160mg per day in EGFR G719X/S768I/L861Q mutant patients under first-line treatment of advanced NSCLC setting.
This is a single arm, multicenter study which will recruit about 30 patients in China. The study is designed to evaluate the efficacy and safety of furmonertinib in the first-line treatment of patients with EGFR G719X/S768I/L861Q mutations in advanced NSCLC. Furmonertinib will be administered orally at a dose of 160 mg per time, Q.D.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Furmonertinib will be administered orally at a dose of 160 mg per time, Q.D.
The Second Affilicated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGChongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGArmy Specialty Medical Center
Chongqing, Chongqing Municipality, China
RECRUITINGObjective Response Rate (ORR)
Objective Response Rate (ORR) (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments) is defined as the number (%) of patients with response of Complete Response or Partial Response. Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be included in the assessment of Objective Response Rate.
Time frame: Approximately 12 months from the first patient begin study treatment
Disease Control Rate (DCR) by Investigator
Disease control rate (DCR) is defined as the percentage of subjects who have a best overall 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.
Time frame: Approximately 12 months from the first patient begin study treatment
Progression-free survival (PFS)
Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). 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). Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable Response Evaluation Criteria in Solid Tumors (RECIST) assessment.
Time frame: Approximately 24 months after the first patient begin study treatment.
Duration of Response (DoR)
Duration of Response is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
Time frame: Duration of Response analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 24 months from the first patient begin study treatment
Overall Survival (OS)
Overall survival is defined as the time from beginning of study treatment until death due to any cause.
Time frame: The analysis of OS will be conducted at 2 time points: when PFS maturity is observed at approximately 24 months after the first patient begin study treatment, and when OS maturity is observed at approximately 36 months after the first patient begin study
Adverse Events
The number of patients with adverse events and the severity according to CTCAE v5.0.
Time frame: From the start of study drug to 30 days after the last dose of study drug
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