The main purpose of this study is to evaluate the efficacy and safety of Icotinib as neoadjuvant in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer which can be potentially radical treated by surgery.
Patients with EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day orally for 8 weeks as neoadjuvant therapy; then patients with clinical benefits receive surgical resection of the tumor. If there is curative effect of Icotinib according to the RECIST or pathological report, the patients will continue receive Icotinib for two years as adjuvant therapy after surgery or till progressive disease or unaccepted toxicity. The primary objective of this study is evaluate the efficacy and safety of Icotinib neoadjuvant therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Patients with EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day orally for 8 weeks as neoadjuvant therapy before surgery and for 2 years as adjuvant therapy or till progressive disease or unaccepted toxicity.
Cancer Hospital, Chinese Academy of Medical Science
Beijing, China
RECRUITINGObjective Response Rate
Time frame: eight weeks
R0 resection rate
Time frame: eight weeks
Disease Control Rate
Time frame: eight weeks
Decrease in cT-stage
Time frame: eight weeks
pathologic complete remission rate
Time frame: eight weeks
Time to Tumor Progression
Time frame: five years after surgery
Overall survival
Time frame: five years after surgery
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: five years after surgery
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