Icotinib is a first-generation inhibitor of EGFR-tyrosine kinase inhibitor in patients with non-small-cell lung cancer (NSCLC). Here we will evaluate neoadjuvant Icotinib with chemotherapy prior to surgery, in patients with resectable stage II-IIIB N2 EGFR mutation-positive NSCLC. The primary endpoint is centrally assessed major pathological response at the time of resection. Secondary endpoints include pathological complete response, objective response rate, R0 resection rate at the time of resection, disease-free survival, and overall survival. Safety and tolerability will also be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
125mg 1tt(Take 1 tablet 3 times a day) orally.
75 mg/m2 (IV,Q3W)
AUC 5 (IV, Q3W)
500 mg/m2 (IV, Q3W)
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Major pathological response(MPR)
Patients with tumors with ≤10% residual viable cancer cells (identified by routine hematoxylin and eosin staining) in the lung primary tumor after neoadjuvant treatment at the time of resection will be considered to have had an MPR.
Time frame: Up to approximately 30 months
Pathological complete response (pCR)
Patients with no residual viable tumor cells in any of the specimens (primary tumors, lymph nodes and margins) will be considered to have had a pCR.
Time frame: Up to approximately 30 months
Objective response rate(ORR)
defined as the sum of the complete response plus partial response divided by the total number of included patients.
Time frame: Up to approximately 30 months
R0 resection rate
Free resection margins proved microscopically;Systematic nodal dissection in its wider form or, if it is not performed, lobe-specific systematic nodal dissection;There should be no extracapsular extension of tumor in nodes removed separately or those at the margin of the main lung specimen. ;The highest mediastinal node that has been removed must be negative.
Time frame: Up to approximately 30 months
Disease-free survival(DFS)
DFS will be defined as the time from surgery until the first instance of disease recurrence (local or distant) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 72 months
Overall survival(OS)
OS will be defined as the time from randomization until death due to any cause.
Time frame: Up to approximately 72 months
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