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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-Small Cell Lung Cancer; Adjuvant Therapy
• Intervention / Treatment: Drug: Third-generation EGFR-TKI

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Nuo Yang, Prof.; Phone Number: +86-0771-5356708; Email: yangnuogxmu@163.com

Study Locations

• China
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The First Affiliated Hospital of Guangxi Medical University
      • Contact: Nuo Yang; Phone Number: +86-0771-5356708; Email: yangnuogxmu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational Group; Third-generation EGFR-TKI adjuvant therapy for Chinese patients with stage IA EGFR-positive NSCLC who have high-risk factors

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Guangxi Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: June 30, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Non-Small Cell Lung Cancer; EGFR Mutation; Stage IA; Third-generation EGFR-TKI; High-risk Factors
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2026-K0033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No