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Набор скоро начнётся NCT06465238

Clinical Study of SHR-A1921 or SHR-A2009 in Previously Treated Advanced NSCLC

Фаза II С лечением 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: SHR-A2009, SHR-A1921.
Кому может быть актуально
Состояния в реестре: NSCLC. 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 Phase II Study of the Efficacy and Safety of SHR-A1921 or SHR-A2009 in Patients With Previously Treated Advanced NSCLC

Обзор

This study is an open-label Phase II clinical trial to evaluate the safety and efficacy of SHR-A1921 or SHR-A2009 in patients with advanced NSCLC who progressed after standard therapy.

Вмешательства

  • Препарат SHR-A2009
    Treatment group: Subjects will receive an intravenous infusion of SHR-A2009 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.
  • Препарат SHR-A1921
    Treatment group: Subjects will receive an intravenous infusion of SHR-A1921 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

Первичные конечные точки

  • Overall response rate (ORR) [Срок оценки: up to 12 months]
Вторичные конечные точки (6)
  • Progression-free survival (PFS) [Срок оценки: up to 12 months]
  • overall survival (OS) [Срок оценки: up to 24 months]
  • Duration of response(DoR ) [Срок оценки: up to 12 months]
  • Disease control rate (DCR) [Срок оценки: up to 12 months]
  • Time to Response (TTR) [Срок оценки: up to 12 months]
  • The incidence and severity of adverse events (AEs) [Срок оценки: from Day1 to 90 days after last dose]

Критерии участия

Критерии включения

  • Voluntary participation and written informed consent;
  • Aged 18-75 years (inclusive), males and females;
  • Has a histologically or cytologically confirmed diagnosis of metastatic NSCLC (according to 8th AJCC/UICC Classification);
  • Has failed to standard therapy and disease progressed after antibody-conjugated drugs therapy;
  • Has at least 1 measurable lesion per RECIST 1.1;
  • Patients with ECOG score of 0-1;
  • Life expectancy ≥12 weeks;
  • Have adequate organ function;
  • Participants agrees to use contraception, and be abstinent from heterosexual intercourse during the treatment period and for ≥180 days after the last dose of study treatment.

Критерии исключения

  • Histologically or cytologically confirmed presence of small-cell lung cancer or other benefit-limiting tumor components;
  • Untreated brain metastasis or accompanied by meningeal metastases, spinal cord compression;
  • Cancerous ascites, pleural effusion or pericardial effusion with clinical symptoms;
  • Subjects who have received systemic anti-tumor treatments prior to the initiation of the study treatment;
  • Has received major organ surgery or high-intensity thoracic radiotherapy within before first dose of study therapy；
  • Has a history of a second malignancy;
  • Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
  • Subjects with active pulmonary tuberculosis infection；
  • Serious infection before the first dose；
  • Uncontrolled cardiac diseases or symptoms;
  • Arterial/venous thrombosis events occurred before the first dose；
  • Hypertension that can not be well controlled through antihypertensive drugs，previous hypertensive crisis or hypertensive encephalopathy；
  • Has a history of active chronic enteritis;
  • Has a history of bleeding prior to the initiation of the study treatment;
  • History of immunodeficiency disease or organ transplant;
  • Subjects with active hepatitis B or active hepatitis C;
  • Has unresolved toxicities from previous anticancer therapy;
  • Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921or SHR-A2009;
  • Subjects with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of the patients.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Henan cancer hospital — Чжэнчжоу

Идентификаторы

NCT: NCT06465238 · NSCLC-IIT-SHRA2009-SHRA1921

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗