Adjuvant Therapy, Non-Small Cell Lung Cancer
Conditions
Keywords
Non-Small Cell Lung Cancer, EGFR Mutation, Stage IA, High-risk Factors, Third-generation EGFR-TKI
Brief 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.
Interventions
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.
Sponsors
First Affiliated Hospital of Guangxi Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old 2. Patients with IA-stage (8th edition of AJCC staging) non-small cell lung cancer (NSCLC) confirmed by histopathology and with high-risk factors 3. EGFR mutation positive 4. No previous systemic anti-tumor treatment 5. Expected or already received surgical treatment 6. Intended to receive or already received third-generation EGFR-TKI adjuvant therapy after surgery.
Exclusion criteria
1. Small cell lung cancer 2. With other malignant tumors that require treatment 3. Pregnant or lactating women 4. Those who the researchers consider not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5-Year Disease-Free Survival rate | 5 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 |
| Disease-free Survival (DFS) | Approximately 5 years | From date of 3rd generation EGFR-TKIs adjuvant therapy started until date of disease recurrence or death (by any cause in the absence of recurrence). |
| 5-Year Overall Survival Rate | 5 years after 3rd generation EGFR-TKIs adjuvant therapy | The proportion of patients alive at 5 years |
| 3-Year Overall Survival Rate | 3 years after 3rd generation EGFR-TKIs adjuvant therapy | The proportion of patients alive at 3 years |
| Overall Survival（OS） | Approximately 5 years | From date of 3rd generation EGFR-TKIs adjuvant therapy started until date of death (by any cause in the absence of recurrence). |
| Incidence of Adverse Events | From the start of adjuvant therapy to 28 days after the end of treatment | The type, frequency and severity of adverse events during treatment (TEAE) and treatment-related adverse events (TRAE) |
Countries
China
Contacts
CONTACTNuo Yang, Prof.
Outcome results
None listed