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Набор скоро начнётся NCT06634667

Third-generation EGFR-TKI Plus Anlotinib as Maintenance for NSCLC With Small Cell Transformation After EGFR-TKI Resistance

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: third-generation EGFR-TKI combined with anlotinib.
Кому может быть актуально
Состояния в реестре: Non-small Cell Lung Cancer. 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

Efficacy and Safety of Third-generation EGFR-TKI Combined With Anlotinib as Maintenance Therapy Following 4-6 Cycles of Chemotherapy and Immunotherapy in NSCLC With Small Cell Transformation After EGFR-TKI Resistance: a Single-arm Prospective Phase II Study

Обзор

This study aimed to evaluate the efficacy and safety of third-generation EGFR-TKI plus anlotinib as maintenance after chemotherapy plus immunotherapy in advanced NSCLC with small cell transformation after EGFR-TKI resistance.

Подробное описание

This prospective interventional clinical study aims to evaluate the efficacy and safety of third-generation EGFR-TKI combined with anlotinib as maintenance therapy following 4-6 cycles of chemotherapy and immunotherapy in patients with advanced NSCLC who developed small cell transformation after EGFR-TKI resistance.Approximately 30 non-small cell lung cancer patients who developed small cell transformation after EGFR-TKI resistance were enrolled and treated with 4-6 cycles of chemotherapy plus immunotherapy followed by maintenance therapy with third-generation EGFR-TKI combined with anlotinib.The study is expected to commence recruitment in mainland China in about November 2024. It is expected that the trial will end in December 2026.

Вмешательства

  • Препарат third-generation EGFR-TKI combined with anlotinib
    third-generation EGFR-TKI combined with anlotinib as maintenance therapy following 4 to 6 cycles of chemotherapy and immunotherapy until progressive disease.

Первичные конечные точки

  • progression-free survival (PFS) [Срок оценки: Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month]
Вторичные конечные точки (2)
  • Objective Response Rate (ORR) [Срок оценки: Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month]
  • Adverse events (AEs) according to CTCAE 5.0 [Срок оценки: Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month]

Критерии участия

Критерии включения

  • 1\. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
  • 2\. Age ≥ 18 years.
  • 3\. Histopathology is confirmed non-small cell lung cancer .
  • 4.Patients with advanced non-small cell lung cancer (NSCLC) who experienced small cell transformation after EGFR-TKI resistance.
  • 5\. Predicted survival ≥ 12 weeks. .
  • 6\. ECOG 0-2.
  • 7\. Adequate bone marrow hematopoiesis and organ function.

Критерии исключения

  • 1\. History of other malignant tumors within 2 years.
  • 2\. Adverse events (except alopecia of any degree) of CTCAE > grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
  • 3\. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
  • 4\. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
  • 5\. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.
  • 6\. Heart-related diseases or abnormalities
  • 7\. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.
  • 8\. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.
  • 9\. Live vaccine was given 2 weeks before the first medication.
  • 10\. Women who are breastfeeding or pregnant.
  • 11\. Hypersensitivity to the test drug and the ingredients.
  • 12\. Other conditions assessed by the investigator to be unsuitable for participation in the study.

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

Китай · 1 центр
  • Yongchang Zhang — Чанша

Идентификаторы

NCT: NCT06634667 · 20241006

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗