A Non-interventional, Real-world Study on the Adjuvant Treatment of Chinese EGFR-positive Stage IA NSCLC Patients With High-risk Factors Using Third-generation EGFR-TKIs.

Condition(s) studied

Investigational drug(s) / intervention(s)

Third-generation EGFR-TKI: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• 3-Year Disease-Free Survival Rate — 3 years after 3rd generation EGFR-TKIs adjuvant therapy
  The proportion of patients who did not PD or all-cause death after 3-years 3rd generation EGFR-TKIs adjuvant therapy

Trial sites (1)

More First Affiliated Hospital of Guangxi Medical University trials in China

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