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Идёт набор NCT05768490

Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases

Фаза III С лечением Brain Metastases Radiotherapy EGFR Activating Mutation

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: brain radiotherapy, Almonertinib.
Кому может быть актуально
Состояния в реестре: Brain Metastases, Radiotherapy, EGFR Activating Mutation. Базовые параметры: 18 лет — 75 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 Prospective, Multicenter, Randomized, Controlled Clinical Study of Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases

Обзор

This is a prospective, multicenter, randomized, controlled clinical study of NSCLC patients with intracranial oligo-metastatic EGFR-sensitive mutations treated with EGFR-TKI Almonertinib , according to the implementation time of brain radiotherapy. Patients were randomly divided into two groups, experimental group (early intervention group of brain radiotherapy) : the brain radiotherapy started within 1 month of TKI treatment, the brain radiotherapy here specifically refers to stereotactic radiotherapy; Control group (brain radiotherapy late intervention group) : Brain radiotherapy was given within 3 months after brain progression during TKI treatment. The differences in OS,iPFS, PFS, iORR, safety, neurocognitive function and quality of life between the two groups were compared.

Вмешательства

  • Лучевая терапия brain radiotherapy
    Patients were randomly divided into two groups, experimental group (early intervention group of brain radiotherapy) : the brain radiotherapy started within 1 month of TKI treatment, the brain radiotherapy here specifically refers to stereotactic radiotherapy; Control group (brain radiotherapy late intervention group) : Brain radiotherapy was given within 3 months after brain progression during TKI treatment.
  • Препарат Almonertinib
    almonertinib po 110mg QD

Первичные конечные точки

  • overall survival [Срок оценки: 3 years]
Вторичные конечные точки (3)
  • intracranial progression free survival [Срок оценки: 2 years]
  • progression free survival [Срок оценки: 2 years]
  • intracranial objective response rate [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Patients with histologically or cytologically confirmed non-small cell lung cancer;
  • Initial diagnosis of intracranial oligometastases (no treatment after brain metastases) was defined as brain parenchymal metastases confirmed by MRI, the number of intracranial parenchymal metastases was less than 5, and the lesions were 3mm away from the optic nerve and brainstem; There must be at least one measurable lesion with a diameter of 5mm or more in the brain.
  • EGFR sensitivity mutation (exon19del or exon21 L858R);
  • Anti-EGFR-targeting drugs and other TKI drugs have not been used in the past;
  • Age 18-75;

Критерии включения

  • A history (past or concurrent) of malignancies in other sites, excluding curable non-melanoma skin cancer and cervical carcinoma in situ;
  • The subjects had received brain radiotherapy before enrollment;
  • Patients whose lung lesions were surgically evaluated as resectable were not included if there was no metastasis in other parts of the body;
  • Received EGFR inhibitors (including small molecule or monoclonal antibody therapy) or systematic anti-tumor therapy before treatment;
  • Prior patients with interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy, or any clinically proven active interstitial lung disease with idiopathic pulmonary fibrosis found on CT scan at baseline;
  • Pregnant and lactating patients;
  • MRI contraindicated patients;
  • Patients who cannot receive oral administration, need intravenous high-energy nutrition, have undergone previous surgery that interferes with absorption, or have active digestive tract ulcers;
  • The researchers judged that brain radiotherapy could not be received because of other head and facial diseases;
  • Any unstable systemic disease (including active infection, poorly controlled hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic disease).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Sun-Yat-Sen university — Guangdong

Идентификаторы

NCT: NCT05768490 · B2022-428-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗