This is a multicenter single arm study, with an aim to assess the effects of adjuvant icotinib among EGFR mutant stage I lung adenocarcinoma patients, who have high-risk pathological features of recurrence.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Within 4-6 weeks after surgery, Icotinib 125mg orally, TID was started for 2 years, or treatment was discontinued due to tumor recurrence or intolerance
Recurrence-Free Survival (RFS)
RFS is defined as the time from the date of curative resection to the first documented recurrence or death due to any cause, whichever occurs first.
Time frame: Up to approximately 10 years
Overall Survival (OS)
OS is defined as the time from the date of randomisation until death due to any cause.
Time frame: Up to approximately 10 years
Safety and tolerability
AEs graded by CTCAE version 5.0
Time frame: Up to approximately 10 years
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