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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Group | Third-generation EGFR-TKI adjuvant therapy for Chinese patients with stage IA EGFR-positive NSCLC who have high-risk factors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Third-generation EGFR-TKI | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-Year Disease-Free Survival Rate | The proportion of patients who did not PD or all-cause death after 3-years 3rd generation EGFR-TKIs adjuvant therapy | 3 years after 3rd generation EGFR-TKIs adjuvant therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 5-Year Disease-Free Survival rate | The proportion of patients who did not PD or all-cause death after 3-years 3rd generation EGFR-TKIs adjuvant therapy | 5 years after 3rd generation EGFR-TKIs adjuvant therapy |
| Disease-free Survival (DFS) |
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Inclusion Criteria:
Exclusion Criteria:
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This is a prospective, non-interventional, real-world study. The study population consists of 500 Chinese patients with stage IA NSCLC with high-risk factors and EGFR mutations. All participants have undergone or are planned to undergo surgical resection and are receiving or planned to receive third-generation EGFR-TKI adjuvant therapy according to the standard of care and the approved registration study protocol. Treatment duration is planned for up to 3 years until disease recurrence/progression, intolerable toxicity, withdrawal of consent, or completion of the 3-year treatment period. The study aims to collect data for final analysis without interfering with the patients' routine clinical treatment decisions.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nuo Yang, Prof. | Contact | +86-0771-5356708 | yangnuogxmu@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China |
This is a single-center retrospective observational study. Due to practical limitations in data management infrastructure and the lack of specific funding allocated for data sharing activities, the research team does not plan to share individual participant data.
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|
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).
| Approximately 5 years |
| 5-Year Overall Survival Rate | The proportion of patients alive at 5 years | 5 years after 3rd generation EGFR-TKIs adjuvant therapy |
| 3-Year Overall Survival Rate | The proportion of patients alive at 3 years | 3 years after 3rd generation EGFR-TKIs adjuvant therapy |
| Overall Survival(OS) | From date of 3rd generation EGFR-TKIs adjuvant therapy started until date of death (by any cause in the absence of recurrence). | Approximately 5 years |
| Incidence of Adverse Events | The type, frequency and severity of adverse events during treatment (TEAE) and treatment-related adverse events (TRAE) | From the start of adjuvant therapy to 28 days after the end of treatment |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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