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Идёт набор NCT06071013

Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients

Фаза I / Фаза II С лечением Non-small Cell Lung Cancer EGFR Gene Mutation EGFR-TKI Resistant 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: Nintedanib, gefitinib, erlotinib, afatinib, osimertinib.
Кому может быть актуально
Состояния в реестре: Non-small Cell Lung Cancer, EGFR Gene Mutation, EGFR-TKI Resistant Mutation. Базовые параметры: 20 лет — 70 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
Тайвань
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 Phase I/Phase II Study of Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients

Обзор

The purpose of this study is to evaluate the efficacy and safety of Nintedanib with EGFR-TKI in participants with advanced EGFR-TKI-resistant non-small cell lung cancer

Подробное описание

The efficacy of the regimen is evaluated by participants' progression-free survival and overall survival.

Nintedanib is a medication that blocks endothelial cells in tumor microenvironments and is effective in delaying tumor progression. Nintedanib is also a drug approved for idiopathic pulmonary fibrosis in the clinic.

The participants will take 1 nintedanib tablet after a meal twice per day with a twelve-hour interval. EGFR TKI-gefitinib, erlotinib, afatinib, or osimertinib will be taken 1 tablet once per day during each treatment cycle. The treatment cycle in this study is 30 days.

In this study, the participants will have a physical exam in 6 weeks and 12 weeks after the initiation of the treatment. In the 6 weeks of the study, the participants will have blood tests and a CT scan. About 5cc of blood will be collected each time. In addition, the participant's tumor will be measured by a CT scan every 12 weeks.

If the participants develop any unacceptable symptoms or changes in liver function tests, the participants' treatment may be delayed and/or the dose decreased until the symptoms are disappeared. It may even be necessary to stop your treatment. The doctor will inform the participant of any changes in the participants' treatment schedule or in the doses of medication after he/she evaluates the participants in the clinic.

After treatment ends, the participants will have a follow-up visit at the clinic. At this visit, the participants will have a complete physical exam, including blood (about 5cc) tests and CT scan to measure the size of the tumors.

This is an investigational study. Up to 20 participants will take part in this study.

Вмешательства

  • Препарат Nintedanib, gefitinib, erlotinib, afatinib, osimertinib
    Nintedanib is a multiple tyrosine kinase inhibitor that can bind competitively to the ATP-binding pocket of these receptors and block intracellular signaling, which is critical for the proliferation and migration. Gefitinib, erlotinib and afatinib are the first- and second- generation of EGFR tyrosine kinase inhibitors that reversibly and irreversibly inhibit the binding of ATP to the phosphate-binding loop of ATP binding site in the kinase domain of EGFR, leading to the inhibition of cell prol

Первичные конечные точки

  • The toxicity of combinate nintedanib and EGFR TKI [Срок оценки: Assessed every 6 weeks of chest CT scan until PD.]
  • Patient objective response rate [Срок оценки: Assessed every 6 weeks of chest CT scan]
Вторичные конечные точки (1)
  • Overall survival [Срок оценки: Assessed every 12 weeks thereafter up to end of study at approximately 2 years]

Критерии участия

Критерии включения

  • Participants between 20 to 70 years old, are pathologically confirmed advanced (stage III and IV) non-small cell lung cancer.
  • Positive EGFR mutations are diagenesis.
  • Participants with histologically/cytologically confirmed locally advanced or metastatic adenocarcinoma subtype NSCLC after the failure of first-line EGFR tyrosine kinase inhibitors- gefitinib, erlotinib, afatinib, or osimertinib.
  • Participants must have adequate hepatic, renal, and bone marrow function

Критерии исключения

  • Participants previously received first-line EGFR tyrosine kinase inhibitor with serious side effects.
  • Participants have known hypertension, and chronic liver and gastrointestinal disease.
  • Participants have known brain metastasis.
  • Female participants who are pregnant or breast-feeding
  • Participants have a known diagnosis of negative nPKCδ expression by immunohistochemistry (IHC).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Тайвань · 1 центр
  • China Medical University Hospital — Taichung

Идентификаторы

NCT: NCT06071013 · CMUH112-REC2-121

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗