Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage II-IIIA non-small cell lung cancer patients with EGFR mutation. The primary endpoint is disease-free survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
125 mg three times daily (375 mg per day) orally for two years.
Vinorelbine 25 mg/m\^2, intravenously guttae, day 1 and day 8, 21 days/cycle, 4 cycles, cisplatin 75 mg/m\^2, intravenously guttae, day 1, 21 days/cycle, 4 cycles. For adenocarcinoma: pemetrexed (500 mg/m\^2, day 1)/cisplatin (75 mg/m\^2, day 1) for 4 cycles.
307 Hospital of PLA
Beijing, Beijing Municipality, China
Fujian Provincal Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital Of Guangzhou Medical Collage
Guangzhou, Guangdong, China
Shenzhen People's Hospital
disease free survival
the time from the date of randomization to the first observation of tumor recurrence, metastasis (based on imaging ) or death
Time frame: 48 months
overall survival
The time from the date of randomization to death from any cause
Time frame: 60 months
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Shenzhen, Guangdong, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, China