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Идёт набор NCT06862869

Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy

— Наблюдательное Carcinoma, Non-Small-Cell Lung

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: Alectinib.
Кому может быть актуально
Состояния в реестре: Carcinoma, Non-Small-Cell Lung. 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

Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy in China: A Multicenter, Prospective Cohort Study

Обзор

This study is a multicenter, prospective, cohort study designed to evaluate the clinical outcomes and characteristics of resected stage II-IIIB anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) adult patients treated with Alectinib as adjuvant therapy in China.

Вмешательства

  • Препарат Alectinib
    Participants will have received alectinib adjuvant treatment for resected stage II-IIIB ALK-positive NSCLC in routine clinical practice. NOTE: No intervention will be provided in this study as the study is observational.

Первичные конечные точки

  • Real-world disease-free survival (rwDFS) [Срок оценки: From baseline to the date of the first documentation of cancer recurrence, as determined by the physician according to local clinical standard of care, or death due to any cause, whichever occurs first (up to approximately 2.5 years)]
Вторичные конечные точки (6)
  • Duration of alectinib therapy [Срок оценки: From start of treatment to the date of treatment discontinuation (up to approximately 2.5 years)]
  • Participant demographics by disease stage and city tier [Срок оценки: Up to approximately 2.5 years]
  • Participant clinical characteristics as determined by Eastern Cooperative Oncology Group performance status (ECOG PS) by disease stage and city tier [Срок оценки: Up to approximately 2.5 years]
  • Participant clinical characteristics as determined by surgery history by disease stage and city tier [Срок оценки: Up to approximately 2.5 years]
  • Emotional and physical functioning as determined by the 36-item short form survey (SF-36) v2 questionnaires [Срок оценки: At enrollment, then every approximately 3 months thereafter (up to approximately 2.5 years)]
  • Incidence and severity of adverse events (AEs) [Срок оценки: Baseline to withdrawal from study or 28 days after the last dose of alectinib, whichever occurs first]

Критерии участия

Критерии включения

  • Histologically-confirmed stage II-IIIA or selected IIIB (T3N2) NSCLC as per the American Joint Committee on Cancer and International Union Against Cancer (UICC/AJCC), 8th edition
  • ALK positive
  • Postoperative NSCLC patients who have undergone complete resection
  • Had taken Alectinib monotherapy without prior systemic therapy (including other ALK-TKIs or chemotherapy) as adjuvant† therapy for resected stage II-IIIB ALKpositive NSCLC and the time from the first dose to enrollment was no more than 28 days

Критерии исключения

  • Patients participating in interventional study of adjuvant treatment
  • Pregnant, lactating, or breastfeeding women

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 · 44 центра
  • Affiliated Hospital of Guangdong Medical University — Zhanjiang
  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Гуанчжоу
  • Huai He Hospital of Henan University — Kaifeng
  • Henan Provincial Chest Hospital — Чжэнчжоу
  • The First Affiliated Hospital of Xinjiang Medical University — Ürümqi
  • Peking University First Hospital — Пекин
  • Xuanwu Hospital, Capital Medical University — Пекин
  • Hunan Cancer Hospital — Чанша
  • … и ещё 36 центров

Идентификаторы

NCT: NCT06862869 · ML45766

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗