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.
Written informed consent
Male or female, aged ≥18 years and ≤75 years
Histologically or cytologically documented lung adenocarcinoma with completely resectable disease (Stage II-IIIB N2, according to the 8th edition of the IASLC Staging Manual in Thoracic Oncology)
Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by an MDT evaluation
Prior treatment with systemic anti-cancer treatment for NSCLC, EGFR-TKI treatment or pre-operative radiotherapy
EGFR-TKI-sensitizing mutations with T790M
Mixed small cell and non-small-cell lung cancer histology
T4 tumors infiltrating the aorta, esophagus and/or heart
Single group
Icotinib
Drug125mg 1tt(Take 1 tablet 3 times a day) orally.
Cisplatin
Drug75 mg/m2 (IV，Q3W)
Carboplatin
DrugAUC 5 (IV, Q3W)
Pemetrexed
Drug500 mg/m2 (IV, Q3W)
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.
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.
Objective response rate(ORR)
defined as the sum of the complete response plus partial response divided by the total number of included patients.
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.
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.
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