A Phase 3 interventional study of 6-month Icotinib and 12-month icotinib in Lung Cancer, sponsored by Sun Yat-sen University. Terminated at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-05.
Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment
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.
7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's enrollment of 251 is above the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.
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Exclusion Criteria:
Icotinib 125 mg three times daily (375 mg per day) by mouth for 6 months
Drug: 6-month Icotinib
Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months
Drug: 12-month icotinib
No intervention
125 mg three times daily (375 mg per day) by mouth for 6 months
Also known as: BPI-2009, Conmana
125 mg three times daily (375 mg per day) by mouth for 12 months
Also known as: BPI-2009, Conmana
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
Ran from Jan 2014 to primary completion in Dec 2021, 95 months.
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This study is terminated, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Icotinib