Идёт набор NCT06767514

Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1

Фаза III 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: Ivonescimab Injection, Pembrolizumab Injection.
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: США, Бельгия, Канада, Китай, Франция +12
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 Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression

Обзор

Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.

Вмешательства

Биопрепарат Ivonescimab Injection
Subject will receive ivonescimab as an IV injection
Биопрепарат Pembrolizumab Injection
Subject will receive Pembrolizumab as an IV injection

Первичные конечные точки

Overall Survival (OS) [Срок оценки: Up to approximately 36 months]
Progression free survival (PFS) [Срок оценки: Up to approximately 36 months]

Вторичные конечные точки (4)

Objective response rate (ORR) [Срок оценки: Up to approximately 36 months]
Disease control rate ( DCR) [Срок оценки: Up to approximately 36 months]
Duration of response (DoR) [Срок оценки: Up to approximately 36 months]
Adverse Events (AE): incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results [Срок оценки: [Time Frame: From the subject signs the ICF to 30 days (AE) and 90 days (SAE related to ivonescimab/pembrolizumab ) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first, Up to approximately 24 months.]

Критерии участия

Критерии включения

Age ≥ 18 years old at the time of enrollment
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1
Expected life expectancy ≥ 3 months
Metastatic (Stage IV) NSCLC
Histologically or cytologically confirmed squamous or non-squamous NSCLC
Tumor demonstrates high PD-L1 expression ( TPS>50%) based on a 22C3 immunohistochemistry ( IHC) clinical assay approved / cleared by local health authorities.
At least one measurable noncerebral lesion according to RECIST 1.1
No prior systemic treatment for metastatic NSCLC.

Критерии исключения

Histologic or cytopathologic evidence of the presence of small cell lung carcinoma for which first-line approved therapies are indicated. For patients with non-squamous histology, actionable driver mutation testing results are required before randomization.
Has received any prior therapy for NSCLC in the metastatic setting.
Concurrent enrollment in another clinical study, unless patient is enrolled in a non-interventional clinical study or is completing survival follow -up.
Known actionable genomic alterations for which first-line approved therapies are indicated
Symptomatic CNS metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease
Other prior malignancy (including previously treated NSCLC) unless the patient has undergone curative therapy with no evidence of recurrence of the disease for 3 years prior to randomization
Active autoimmune or lung disease requiring systemic therapy
Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5
Severe infection within 4 weeks prior to randomization
Major surgical procedures or serious trauma within 4 weeks prior to randomization
History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease

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: Четверное слепое
Основная цель: Лечение