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Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study): Study
Yu-Tao Liu1, Xue-Zhi Hao1, De-Ruo Liu2
1Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People's Republic of China.
Abstract:
The efficacy and possible role of epidermal growth factor receptor tyrosine kinase inhibitors in treating early-stage non-small-cell lung cancer have yet to be established. Therefore, we aimed to explore the efficacy and safety of icotinib in completely resected EGFR-mutant stage II-IIIA lung adenocarcinoma patients who underwent standard chemotherapy. This is a randomised, double-blinded, placebo-controlled, multicentre, Phase III trial. A total of 124 patients aged 18-75 years who qualified the inclusion criteria were recruited. These patients were randomised (1:1) to receive either icotinib (125 mg 3 times per day) or placebo (the same dosage and frequency) for 36 months, followed by a further 36 months of observational window. The primary endpoint is disease-free survival (DFS), while the secondary endpoints are overall survival, 3-year and 5-year DFS, safety and tolerability of the medication, and health-related quality-of-life. Analyses will be conducted in a full analysis set and a per-protocol set as well. To our knowledge, the present study is the first randomised, double-blinded, placebo-controlled, multicenter trial designed to explore efficacy and safety of icotonib in this population. The results obtained in the near future may provide potential guidance in clinical practice. Trial Registration: This trial was registered on www.ClinicalTrail.gov as NCT02125240.
Insights
This Phase III trial investigated icotinib for early-stage non-small-cell lung cancer. The study assessed icotinib
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) role in early-stage non-small-cell lung cancer (NSCLC) is not fully established.
- Icotinib is an EGFR-TKI with potential therapeutic applications.
- Standard chemotherapy is the current treatment for resected NSCLC.
Purpose of the Study:
- To evaluate the efficacy and safety of icotinib as an adjuvant therapy in patients with resected EGFR-mutant stage II-IIIA NSCLC.
- To compare disease-free survival (DFS) and overall survival (OS) between icotinib and placebo groups.
- To assess the safety, tolerability, and quality of life associated with icotinib treatment.
Main Methods:
- A randomized, double-blinded, placebo-controlled, multicenter Phase III trial.
- 124 eligible patients with resected EGFR-mutant stage II-IIIA NSCLC were randomized (1:1) to receive icotinib (125 mg TID) or placebo for 36 months.
- Primary endpoint: DFS. Secondary endpoints: OS, 3- and 5-year DFS, safety, tolerability, and quality of life.
Main Results:
- Data collection and analysis are ongoing.
- The study is designed to provide robust evidence on icotinib's efficacy and safety in this patient population.
- Results are anticipated to inform clinical practice guidelines.
Conclusions:
- The study is the first randomized, double-blinded, placebo-controlled trial to assess icotinib in resected EGFR-mutant NSCLC.
- Findings will potentially guide the use of icotinib in adjuvant settings for NSCLC.
- The trial aims to establish icotinib as a valuable treatment option for early-stage NSCLC.
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