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0 reviewsThe efficacy, safety and ideal treatment duration of an adjuvant epidermal growth factor receptor tyrosine kinase inhibitor (EGFRTKI) for patients with resected EGFR-mutated non-small-cell lung cancer (NSCLC) were not known until 2014, when this study wasinitiated. In this phase 3 ICTAN trial (GASTO1002, NCT01996098), patients with completely resected, EGFR-mutated, stage II-IIIANSCLC after adjuvant chemotherapy were assigned in a 1:1:1 ratio to receive icotinib (125 mg, three times daily) for 12 months, toreceive icotinib for 6 months, or to undergo observation. The primary endpoint was disease-free survival (DFS). This trial wasterminated early. A total of 251 patients were randomized. Adjuvant icotinib for 12 months significantly improved DFS (hazard ratio1234567890();,:[HR]: 0.40, 95% confidence interval [CI], 0.27–0.61; P < 0.001) and overall survival (OS; HR: 0.55, 95% CI, 0.32–0.96; P = 0.032)compared with observation. Adjuvant icotinib of 6 months also significantly improved DFS (HR: 0.41, 95% CI, 0.27–0.62; P < 0.001)and OS (HR: 0.56, 95% CI, 0.32–0.98; P = 0.038) compared with observation. Adjuvant icotinib for 12 months did not improve DFS(HR: 0.97; P = 0.89) or OS (HR: 1.00; P = 0.99) compared with 6 months of this drug. Rates of adverse events of grade 3 or higherwere 8.3%, 6.0% and 2.4% for the 12-month icotinib, 6-month icotinib, and observation groups, respectively. Adjuvant icotinib for12 months or 6 months following adjuvant chemotherapy improved DFS and OS compared with observation in patients withresected EGFR-mutated stage II-IIIA NSCLC with a manageable safety profile, supporting it as a potential treatment option.Signal Transduction and Targeted Therapy (2025) 10:273 ;
