This study aims to evaluate the real-world effectiveness and safety of third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs)-such as osimertinib, aumolertinib, and furmonertinib-as adjuvant therapy for patients with early-stage non-small cell lung cancer (NSCLC) in China. Approximately 500 eligible patients are planned to be enrolled. All participants must have been diagnosed with Stage IA NSCLC (according to the 8th edition of the AJCC staging system) following surgical resection, harboring EGFR-sensitive mutations, and presenting with high-risk recurrence factors (e.g., poor differentiation, lymphovascular invasion, and spread through air spaces). This is a non-interventional, real-world study that does not alter physicians' original prescribing habits or clinical management strategies. Patients will receive standard treatment with third-generation EGFR-TKIs according to routine clinical practice (typically for a duration of three years). The research team will periodically collect follow-up data, with a primary focus on postoperative disease-free survival (DFS) and drug safety profiles. Through this investigation, we seek to determine whether this specific population of high-risk early-stage patients can derive clinical benefit from postoperative targeted therapy. The findings are expected to provide evidence to support the development of future clinical guidelines.
Study Type
OBSERVATIONAL
Enrollment
500
This is an observational, non-interventional study. The interventions listed herein refer to routine standard adjuvant therapies administered entirely at the discretion and implementation of the attending physicians, without any interference from the study protocol. The research team is solely responsible for observing and collecting data, and does not participate in or influence patients' treatment decisions.
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
3-Year Disease-Free Survival Rate
The proportion of patients who did not PD or all-cause death after 3-years 3rd generation EGFR-TKIs adjuvant therapy
Time frame: 3 years after 3rd generation EGFR-TKIs adjuvant therapy
5-Year Disease-Free Survival rate
The proportion of patients who did not PD or all-cause death after 3-years 3rd generation EGFR-TKIs adjuvant therapy
Time frame: 5 years after 3rd generation EGFR-TKIs adjuvant therapy
Disease-free Survival (DFS)
From date of 3rd generation EGFR-TKIs adjuvant therapy started until date of disease recurrence or death (by any cause in the absence of recurrence).
Time frame: Approximately 5 years
5-Year Overall Survival Rate
The proportion of patients alive at 5 years
Time frame: 5 years after 3rd generation EGFR-TKIs adjuvant therapy
3-Year Overall Survival Rate
The proportion of patients alive at 3 years
Time frame: 3 years after 3rd generation EGFR-TKIs adjuvant therapy
Overall Survival（OS）
From date of 3rd generation EGFR-TKIs adjuvant therapy started until date of death (by any cause in the absence of recurrence).
Time frame: Approximately 5 years
Incidence of Adverse Events
The type, frequency and severity of adverse events during treatment (TEAE) and treatment-related adverse events (TRAE)
Time frame: From the start of adjuvant therapy to 28 days after the end of treatment
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