Меню
Набор скоро начнётся NCT07596524

Analysis of Different Second Line Treatment in Advanced NSCLC Patients Progressing After 1st Line Immune Checkpoint Inhibitor Therapy

— Наблюдательное Lung Cancer (NSCLC)

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: Observation.
Кому может быть актуально
Состояния в реестре: Lung Cancer (NSCLC). Базовые параметры: от 1 год · 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Analysis of Different Treatment Modalities and Clinical Outcomes in Advanced NSCLC Patients Progressing After First-Line Immune Checkpoint Inhibitor Therapy: An Observational Study Based on Real-World Data

Обзор

The second-line treatment options in clinical practice for immunotherapy progress are complex. Treatment strategies need to be selected based on different progression patterns. It is difficult to simultaneously explore multiple treatment modalities through previous clinical studies. Observational studies through real-world research can efficiently convert clinical practice data into clinical treatment evidence. This study aims to observe the treatment patterns and clinical outcomes of advanced NSCLC patients who received first-line immunotherapy checkpoint inhibitor treatment after progression, in order to provide guidance for the second-line treatment options for patients with first-line immunotherapy progress.

Вмешательства

  • Другое Observation
    The patients' second-line treatment received and the follow-up observations were retrospectively collected.

Первичные конечные точки

  • Overall Survival [Срок оценки: Time from 2nd line treatment initiation to patient death from any cause, assessed up to 60 months]
  • Progression Free Survival [Срок оценки: Time from 2nd line treatment initiation to the first recorded progression event in the medical information system (radiographic report or physician assessment) or death from any cause, whichever occurs first, assessed up to 60 months]
Вторичные конечные точки (3)
  • Objective Response Rate [Срок оценки: From 2nd line treatment initiation, assessed up to 24 months]
  • Disease control rate [Срок оценки: From 2nd line treatment initiation, assessed up to 24 months]
  • Immune-related adverse events [Срок оценки: From 2nd line treatment initiation and before 3rd line treatment, assessed up to 24 months]

Критерии участия

Критерии включения

  • Locally advanced or metastatic NSCLC that is not curable and confirmed by histological or cytological examination based on the 8th edition of AJCC staging.
  • Previously received advanced first-line treatment based on immune checkpoint inhibitor drugs.
  • Has a medical record of disease progression during the first-line treatment.
  • Complete clinical and pathological data, such as age, gender, smoking history, primary tumor location, differentiation, metastatic site, and imaging and serological review as required.

Критерии исключения

  • First-line treatment with immune checkpoint inhibitor drugs was ≤ 2 cycles.
  • Excluding patients with incomplete key baseline and treatment information.
  • Have other potential factors that may affect the study results or result in the premature discontinuation, as determined by the investigator

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Китай · 3 центра
  • Cancer Hospirtal, Chinese Academy of Medical Sciences — Пекин
  • Cancer Hospirtal, Chinese Academy of Medical Sciences, Shenzhen — Шэньчжэнь
  • Shanxi Provincial Cancer Hospital — Taiyuan

Идентификаторы

NCT: NCT07596524 · NCC-021875

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗