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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Third-generation EGFR-TKI.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer, Adjuvant Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Non-interventional, Real-World Study of Third-Generation EGFR-TKI Adjuvant Therapy in Chinese EGFR-Positive Stage IA Non-Small Cell Lung Cancer Patients With High-Risk Factors
Overview
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.
Interventions
- Drug 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.
Primary outcome measures
- 3-Year Disease-Free Survival Rate [Time frame: 3 years after 3rd generation EGFR-TKIs adjuvant therapy]
Secondary outcome measures (6)
- 5-Year Disease-Free Survival rate [Time frame: 5 years after 3rd generation EGFR-TKIs adjuvant therapy]
- Disease-free Survival (DFS) [Time frame: Approximately 5 years]
- 5-Year Overall Survival Rate [Time frame: 5 years after 3rd generation EGFR-TKIs adjuvant therapy]
- 3-Year Overall Survival Rate [Time frame: 3 years after 3rd generation EGFR-TKIs adjuvant therapy]
- Overall Survival（OS） [Time frame: Approximately 5 years]
- Incidence of Adverse Events [Time frame: From the start of adjuvant therapy to 28 days after the end of treatment]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital of Guangxi Medical University — Nanning
Identifiers
NCT: NCT07686185 · 2026-K0033