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Идёт набор NCT06394674

High-dose Furmonertinib in the Treatment in Patients With Advanced, Metastatic NSCLC With Progressed After First- or Second-line Treatment With Osimertinib

Фаза II С лечением Non-Small Cell Lung Cancer

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: Furmonertinib.
Кому может быть актуально
Состояния в реестре: Non-Small Cell Lung Cancer. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Prospective, Randomized, Phase ll Clinical Trial of Single-agent Treatment With Different Doses of Sulfamethoxazole Furmonertinib in Patients With Advanced, Metastatic Lung Adenocarcinoma Who Have Progressed After First- or Second-line Treatment With EGFR-TKl Osimertinib

Обзор

This is a prospective, randomised, uncontrolled phase II clinical trial planned to include 84 subjects with metastatic lung adenocarcinoma that had progressed after first- or second-line treatment with Osmertinib, who were randomly assigned to trial group 1 and trial group 2, and were given Furmonertinib 160 mg and 240 mg once/day, orally, respectively, with efficacy evaluated every 6 weeks until disease progression, intolerable toxic side effects, or Subjects voluntarily withdrew informed consent.

Вмешательства

  • Препарат Furmonertinib
    Drug: Furmonertinib

Первичные конечные точки

  • Objective Response Rate(ORR) [Срок оценки: Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment]
Вторичные конечные точки (3)
  • Progression-free survival (PFS) [Срок оценки: The primary analysis of Progression-free survival (PFS) based on investigator assessment will occur when PFS maturity is observed at approximately 12 months after the first patient begin study treatment]
  • Disease Control Rate (DCR) [Срок оценки: Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment]
  • Duration of Response (DoR) [Срок оценки: Duration of Response analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 12 months from the first patient begin study treatment]

Критерии участия

Критерии включения

  • Histologically or cytologically confirmed metastatic lung adenocarcinoma
  • Progression of imaging-confirmed extracranial lesions after first- or second-line treatment with Osimertinib
  • Previous genetic testing for a definite EGFR-sensitive mutation and imaging-confirmed extracranial lesion progression after first-line treatment with Osimertinib; or previous genetic testing for a definite T790M mutation and imaging-confirmed extracranial lesion progression after second-line treatment with Osimertinib.
  • Pre-existing clinical benefit after treatment with Osimertinib, including CR, PR, SD (duration >6 months);
  • Patients with at least 1 measurable lesion according to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1)
  • Normal functioning of major organs
  • Pre-menopausal women of childbearing potential with a negative serum or urine pregnancy test within 7 days prior to the first dose of the drug
  • Subjects volunteered and signed a written informed consent form.

Критерии исключения

  • Previous chemotherapy or immunotherapy
  • Patients with non-lung adenocarcinoma, including squamous lung cancer or mixed histological types
  • Progression of imaging-confirmed extracranial lesions after prior Osimertinib treatment with accessible treatment options after genetic testing
  • Patients with symptomatic brain metastases, meningeal metastases or spinal cord compression
  • Any unrecovered CTCAE > grade 1 toxicity reaction following prior Osimertinib treatment at the start of study drug therapy
  • Other malignant tumors within 5 years or history of other malignant tumours; except effectively controlled basal cell carcinoma of the skin, carcinoma in situ of the uterine cervix, ductal carcinoma in situ of the breast, papillary carcinoma of the thyroid, superficial bladder tumors, etc.
  • History of interstitial pneumonia with previous diagnosis
  • Other circumstances that, in the judgement of the investigator, make them unsuitable for inclusion in the study

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
  • Changhai Hospital — Шанхай

Идентификаторы

NCT: NCT06394674 · CHEC2023-155

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗