Randomized, Open Label, Positive Controlled, Multicenter Trial to Evaluate Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma
This study is designed to compare the efficacy and safety of first-line icotinib treatment
and first-line chemotherapy followed by maintenance with icotinib.
Progression-free survival between first-line icotinib treatment and first-line chemotherapy
followed by maintenance with icotinib
1. Overall survival between icotinib and chemotherapy
2. Time to Progression between icotinib and chemotherapy
3. Objective response rate and disease control rate between icotinib and chemotherapy
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.
Jiao Shunchang, MD
Chinese People's Liberation Army (PLA) General Hospital
China: Food and Drug Administration