The purpose of this study is studying icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation.
Adjuvant chemotherapy is recommended for routine use in patients with fully resected stage IIA-IIIA non-small cell lung cancer (NSCLC). Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced non-small cell lung cancer (NSCLC) with EGFR mutation. Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists. In the phase III ICOGEN trial, icotinib had non-inferiority efficacy to gefitinib with better safety. In phase II trial, chemotherapy followed by 6-month gefitinib as adjuvant therapy can confer longer disease-free survival compared with chemotherapy alone in patients with resected stage IIIA-N2 non-small cell lung cancer harboring EGFR mutations. This study is to studying 6-month or 12-month icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
251
125 mg three times daily (375 mg per day) by mouth for 6 months
125 mg three times daily (375 mg per day) by mouth for 12 months
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Disease-Free Survival
Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.
Time frame: 5 years after the last patient is randomized
Overall Survival
Overall survival was assessed from randomization to death as a result of any cause.
Time frame: 5 years after the last patient is randomized
Number of Participants with Adverse Events
To assess if the addition of icotinib to chemotherapy is safe.
Time frame: 2 years
Change from baseline in patient reported Lung Cancer Functional Assessment
Quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire.
Time frame: 2 years
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