The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
NCT Number: NCT07686185
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Nanning, Guangxi, 530021, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 5 years after 3rd generation EGFR-TKIs adjuvant therapy
The proportion of patients alive at 5 years
Time frame: 3 years after 3rd generation EGFR-TKIs adjuvant therapy
The proportion of patients alive at 3 years
Time frame: 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).
Time frame: 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)
Contact information is provided by the study sponsor or research team.
First Affiliated Hospital of Guangxi Medical University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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