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Набор скоро начнётся 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.

— Наблюдательное Non-Small Cell Lung Cancer Adjuvant Therapy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Third-generation EGFR-TKI.
Кому может быть актуально
Состояния в реестре: Non-Small Cell Lung Cancer, Adjuvant Therapy. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Препарат 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.

Первичные конечные точки

  • 3-Year Disease-Free Survival Rate [Срок оценки: 3 years after 3rd generation EGFR-TKIs adjuvant therapy]
Вторичные конечные точки (6)
  • 5-Year Disease-Free Survival rate [Срок оценки: 5 years after 3rd generation EGFR-TKIs adjuvant therapy]
  • Disease-free Survival (DFS) [Срок оценки: Approximately 5 years]
  • 5-Year Overall Survival Rate [Срок оценки: 5 years after 3rd generation EGFR-TKIs adjuvant therapy]
  • 3-Year Overall Survival Rate [Срок оценки: 3 years after 3rd generation EGFR-TKIs adjuvant therapy]
  • Overall Survival（OS） [Срок оценки: Approximately 5 years]
  • Incidence of Adverse Events [Срок оценки: From the start of adjuvant therapy to 28 days after the end of treatment]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • The First Affiliated Hospital of Guangxi Medical University — Nanning

Идентификаторы

NCT: NCT07686185 · 2026-K0033

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗