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.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Guangxi Medical University

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Third-generation EGFR-TKI

Treatment groups

500 Participants
are divided into 1 treatment group