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.

Starting soon

Conditions studied: Non-Small Cell Lung Cancer, Adjuvant Therapy

In brief

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.

Key facts

Study ID

NCT07686185

Run by

First Affiliated Hospital of Guangxi Medical University

People needed

500

Starts

2026-09-01

Expected to finish

2032-12-31

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old
• Patients with IA-stage (8th edition of AJCC staging) non-small cell lung cancer (NSCLC) confirmed by histopathology and with high-risk factors
• EGFR mutation positive
• No previous systemic anti-tumor treatment
• Expected or already received surgical treatment
• Intended to receive or already received third-generation EGFR-TKI adjuvant therapy after surgery.

You may not qualify if…

• Small cell lung cancer
• With other malignant tumors that require treatment
• Pregnant or lactating women
• Those who the researchers consider not suitable to participate in this clinical trial.

Where it is running

• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China

Full record on ClinicalTrials.gov

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