NCT07686185Not yet recruiting
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.
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
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 30 Jun 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Sept 2031
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Diseases
- Lung cancer
- NCT number
- NCT07686185
What you commit to
- Study type: Observational
- Planned participants: 500
- From 1 Sept 2026 to the primary completion date, 1 Sept 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Small cell lung cancer
- With other malignant tumors that require treatment
Other
- Pregnant or lactating women
- Those who the researchers consider not suitable to participate in this clinical trial.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.