This is a phase II study aimed to assess the efficacy and safety of furmonertinib, a third generation EGFR TKI, as perioperation therapy in stage IIIA-IIIB (N1-N2) resectable NSCLC patients.
Please refer to detailed description in the following context.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Furmonertinib 80mg/d as neoadjuvant therapy for 8 weeks before surgery, then as adjuvant therapy for 3 years after surgery.
Objective Response Rate (ORR)
Proportion of patients whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1
Time frame: Approximately 8 weeks following the first dose of study drug
Disease Control Rate (DCR)
Proportion of patients whose tumors were assessed as CR, PR or stable disease (SD) according to RECIST 1.1
Time frame: Approximately 8 weeks following the first dose of study drug
Progression free survival (PFS)
The time from the first does of the study drugs to the progression of the disease or death for any reason.
Time frame: Approximately 3 years following the first dose of study drug
Disease free survival (DFS)
The time from the end of surgery to the progression of the disease or death for any reason.
Time frame: Approximately 3 years following the first dose of study drug
Adverse Events (AEs)
The number of patients with adverse events and the severity according to CTCAE v5.0
Time frame: From the start of study drug to 28 days after the last dose of study drug
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