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NCT Number: NCT07686185

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.

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Small cell lung cancer
  • With other malignant tumors that require treatment
  • Pregnant or lactating women
  • Those who the researchers consider not suitable to participate in this clinical trial.

Treatment and study plan

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.

Primary outcomes

  1. 3-Year Disease-Free Survival Rate

    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

Secondary outcomes

  1. 5-Year Disease-Free Survival rate

    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

  2. Disease-free Survival (DFS)

    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).

  3. 5-Year Overall Survival Rate

    Time frame: 5 years after 3rd generation EGFR-TKIs adjuvant therapy

    The proportion of patients alive at 5 years

  4. 3-Year Overall Survival Rate

    Time frame: 3 years after 3rd generation EGFR-TKIs adjuvant therapy

    The proportion of patients alive at 3 years

  5. Overall Survival(OS)

    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).

  6. Incidence of Adverse Events

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Nuo Yang, Prof.

CONTACT

[email protected]

+86-0771-5356708

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Guangxi Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

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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