Abstract 948TiP
Background
Pathological subtypes are prognostic indicators independent of TNM stage, and patients with micropapillary and solid components have poorer prognosis. Previous studies have found that the presence of a micropapillary component was significantly associated with worse recurrence-free survival in patients with stage I lung adenocarcinoma, even the components are less than 5%, and postoperative adjuvant chemotherapy can still bring benefit to those patients even with stage IA. Third-generation EGFR-TKI have recently shown striking benefit for postoperative adjuvant therapy in patients with EGFR-mutated NSCLC. At present, there is no systematic study on the efficacy and safety of third-generation EGFR-TKI in stage I NSCLC patients with high-risk recurrence factors, such as solid and micropapillarycomponents. The third-generation EGFR-TKI, aumolertinib(HS-10296), showed promising efficacy in advanced NSCLC patients with sensitive EGFR mutation. This is the first study to explore the efficacy and safety of aumolertinib as adjuvant therapy in patients with EGFR mutant stage I NSCLC with solid and/or micropapillary component.
Trial design
Approximately 52 stage I EGFR-mutated NSCLC patients with solid and/or micropapillary components ≥10% will be enrolled in this multicenter single-arm study. After radical lung cancer surgery, they will receive oral almonertinib 110 mg/d as adjuvant therapy for 3 years. The primary endpoint is 2-year disease free survival (DFS) rates, and secondary endpoints included the 3-, 4-, and 5-year DFS rates, 5-year overall survival rates, safety and quality of life, Circulating tumor DNA will also be monitored during the study. Recruitment of this study is ongoing, and the first patient had been enrolled in January 2022.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The author.
Funding
Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.