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Идёт набор NCT05598528

Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)

— Наблюдательное Lung Cancer, Non-small Cell EGFR Gene Mutation EGFR-TKI Resistant Mutation Primary Resistance

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: Genomic profiles detection, circulating tumor DNA detection.
Кому может быть актуально
Состояния в реестре: Lung Cancer, Non-small Cell, EGFR Gene Mutation, EGFR-TKI Resistant Mutation, Primary Resistance. 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 Multicenter Clinical Study to Explore the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)

Обзор

Lung cancer is currently the world's largest malignant tumor for cancer-related deaths with non-small cell lung cancer (NSCLC) accounting for 80%-85%. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), especially the 3rd-generation EGFR-TKIs have demonstrated strong antitumor effects in EGFR-positive patients. However, approximately 20% of EGFR-positive were primarily resistant to 3rd generation EGFR-TKIs, i.e., clinical non-response or disease progression in the short term. This study aimed to clarify the molecular indicators that predict the benefits of 3-rd EGFR-TKIs as first-line therapy in NSCLCpatients with EGFR-positive. Further, to clarify their primary drug resistance mechanisms, which is of great significance for the treatment and clinical decision-making of NSCLC disease.

Вмешательства

  • Другое Genomic profiles detection
    The Paraffin-embedded tumor tissue at diagnosis is collected and assessed by Next- generation gene sequencing
  • Другое circulating tumor DNA detection
    The Plasma at diagnosis and at 1-month treatment are collected and assessed by Next-generation gene sequencing

Первичные конечные точки

  • Objective Response Rate (ORR) [Срок оценки: 2 years]
  • Progression-free survival (PFS) [Срок оценки: 3 years]
  • Differences in genomic profiles of tumor tissues and ctDNA clearance of third-generation EGFR-TKIs sensitive and primary drug-resistant NSCLC. [Срок оценки: 3 years]
Вторичные конечные точки (2)
  • Overall survival (OS) [Срок оценки: 5 years]
  • Disease Control Rate (DCR) [Срок оценки: 3 years]

Критерии участия

Критерии включения

  • Age >18 years;
  • Histological or cytopathological diagnosed NSCLC;
  • According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is unresectable IIIB-IV or recurrence and metastasis after surgery;
  • At least one measurable lesion can be evaluated according to the Response Evaluation Criteria In Solid Tumours v1.1 (RECIST1.1) criteria;
  • Positive EGFR mutation confirmed by tissue or cytology (pleural fluid, cerebrospinal fluid, etc.);
  • Use of third-generation EGFR-TKIs approved by the NMPA for NSCLC as first-line therapy;
  • Cooperate with the provision of clinicopathological data, imaging data, sample collection, and follow-up required for the research process, and agree to use the test data for subsequent research and product development;
  • Agree to participate in this study and sign an informed consent form.

Критерии исключения

  • Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form;
  • Pregnant and lactating women;
  • Other malignant neoplastic diseases within 3 years;
  • Patients who have undergone other clinical drug trials;
  • Received systemic anti-tumor therapy within 2 years;

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
  • Department of Oncology, The Second Xiangya Hospital, Central South University — Чанша

Идентификаторы

NCT: NCT05598528 · XYEYY20220928

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗