This phase II trial studies how well icotinib works in treating patients with completely resected stage IB NSCLC harboring EGFR mutation.
Adjuvant chemotherapy have shown little evidence of survival benefit in patients with stages IB non-small cell lung cancer (NSCLC) after complete resection. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with EGFR mutant non-small cell lung cancer (NSCLC). Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. In the phase III ICOGEN trial, icotinib had non-inferiority efficacy to gefitinib with better safety. This study is studying icotinib to see how well it works in treating patients with fully resected stage IB NSCLC harboring EGFR mutation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
3-year Disease-Free Survival
3-year DFS was defined as the percentage of patients who were disease free at 3 years. 3-year DFS were calculated by the Kaplan-Meier method, and the difference in 3-year DFS between groups was compared by the Z test.
Time frame: From randomization to the time of disease recurrence or death as a result of any cause, assessed up to 3 years
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