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Идёт набор NCT07245446

A Study of Ivonescimab in First-Line ES-SCLC

Фаза II С лечением Extensive-stage Small Cell Lung Cancer (ES-SCLC)

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: Ivonescimab, Cadonilimab, AK117, Etoposide.
Кому может быть актуально
Состояния в реестре: Extensive-stage Small Cell Lung Cancer (ES-SCLC). 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 Clinical Study of Ivonescimab Combination Therapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Обзор

The goal of this clinical trial is to learn if different combinations of a drug called Ivonescimab, along with chemotherapy and other investigational drugs, are safe and effective for the initial treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). The main questions the study aims to answer are: * What side effects do participants experience from these combination treatments? * How well do the treatments work to shrink tumors? Researchers will compare three groups to see which combination works best. All participants will receive Ivonescimab and chemotherapy (etoposide and carboplatin). The differences are: * Group 1 will also receive an additional drug called AK117. * Group 2 will also receive a different additional drug called Cadonilimab. * Group 3 will receive Ivonescimab and chemotherapy only. Participants will: * Be assigned by chance to one of the three groups. * Undergo an initial treatment phase (about 3 months), receiving chemotherapy plus the specific study drugs for their group. * If the treatment is effective and side effects are manageable, continue with a maintenance phase using only the study drugs (without chemotherapy) for up to 2 years. * Attend regular clinic visits for check-ups, blood tests, and imaging scans (like CT scans) to see how they are responding to the treatment.

Вмешательства

  • Препарат Ivonescimab
    Administered intravenously at a specified dose and frequency.
  • Препарат Cadonilimab
    Administered intravenously at a specified dose and frequency.
  • Препарат AK117
    Administered intravenously at a specified dose and frequency.
  • Препарат Etoposide
    Administered intravenously at 100 mg/m² on Days 1-3 of each 3-week cycle for 4 cycles.
  • Препарат Carboplatin (AUC 5)
    Administered intravenously at AUC 5 on Day 1 of each 3-week cycle for 4 cycles.

Первичные конечные точки

  • Objective Response Rate (ORR) [Срок оценки: Up to approximately 2 years.]
  • Incidence of Adverse Events (AEs) [Срок оценки: From first dose up to 90 days after last dose.]
Вторичные конечные точки (7)
  • Disease Control Rate (DCR) [Срок оценки: Up to approximately 2 years.]
  • Duration of Response (DoR) [Срок оценки: Up to approximately 2 years.]
  • Time to Response (TTR) [Срок оценки: Up to approximately 2 years.]
  • Progression-Free Survival (PFS) [Срок оценки: Up to approximately 2 years.]
  • Overall Survival (OS) [Срок оценки: Up to approximately 5 years.]
  • Serum concentrations of Ivonescimab, Cadonilimab, and AK117 [Срок оценки: Up to approximately 2 years.]
  • Incidence of Anti-drug Antibodies (ADA) [Срок оценки: Up to approximately 2 years.]

Критерии участия

Критерии включения

  • Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
  • No prior systemic therapy for ES-SCLC.
  • At least one measurable lesion as defined by RECIST v1.1.
  • Age 18 to 75 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function.

Критерии исключения

  • Active or untreated central nervous system (CNS) metastases (Treated, stable brain metastases are allowed).
  • History of severe hypersensitivity to monoclonal antibodies.
  • Active autoimmune disease requiring systemic treatment within the past 2 years.
  • Significant cardiovascular disease.
  • Active hepatitis B or C, or HIV infection.
  • Interstitial lung disease or non-infectious pneumonitis.
  • Significant bleeding tendency or risk, including tumor invasion of major blood vessels.
  • Pregnancy or lactation.
  • Other active malignancies within 5 years prior to enrollment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 3 центра
  • Cancer Hospital Chinese Academy of Medical Sciences — Пекин
  • The First Affiliated Hospital of Xi'an Jiaotong University — Сиань
  • Shanghai Pulmonary Hospital Affiliated to Tongji University — Шанхай

Идентификаторы

NCT: NCT07245446 · AK112-214

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗