Идёт набор NCT05211895

A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC

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: Durvalumab, Domvanalimab, Placebo.
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, Бразилия, Канада, Чили +23
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 III, Randomised, Double-blind, Placebo-controlled, Multicentre, International Study of Durvalumab Plus Domvanalimab(AB154) in Participants With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer Whose Disease Has Not Progressed Following Definitive Platinum-based Concurrent Chemoradiation Therapy

Обзор

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.

Вмешательства

Препарат Durvalumab
Durvalumab IV (Intravenous infusion)
Препарат Domvanalimab
Domvanalimab IV (Intravenous infusion)
Другое Placebo
Placebo IV (Intravenous infusion)

Первичные конечные точки

Progression Free Survival (PFS) [Срок оценки: Up to 8 years after randomization]

Вторичные конечные точки (12)

Progression Free Survival (PFS) [Срок оценки: Up to 8 years after randomization]
Overall Survival (OS) [Срок оценки: Approximately 8 years after randomization]
Objective Response Rate (ORR) [Срок оценки: Approximately 8 years after randomization]
Duration of Response (DoR) [Срок оценки: Approximately 8 years after randomization]
Time from randomization to second progression (PFS2) [Срок оценки: Approximately 8 years after randomization]
Time from randomization to first date of distant metastasis or death (TTDM) [Срок оценки: Approximately 8 years after randomization]
Time to first subsequent therapy (TFST) [Срок оценки: Approximately 8 years after randomization]
Concentration of Durvalumab and Domvanalimab [Срок оценки: Approximately 12 weeks after last IP dose]
PFS6, PFS12, PFS18, PFS24 [Срок оценки: Approximately 6, 12, 18 and 24 months after randomization]
Anti-Drug Antibodies (ADAs) [Срок оценки: Approximately 12 weeks after last IP dose.]
Time to deterioration in pulmonary symptoms (TTFCD) [Срок оценки: Approximately 8 years after randomization]
PFS investigator [Срок оценки: Up to 8 years after randomization]

Критерии участия

Критерии включения

Participant must be ≥ 18 years at the time of screening.
Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
Provision of a tumour tissue sample obtained prior to CRT
Documented tumour PD-L1 status ≥ 1% by central lab
Documented EGFR and ALK wild-type status (local or central).
Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy
Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.
WHO performance status of 0 or 1 at randomization
Adequate organ and marrow function

Критерии исключения

History of another primary malignancy, except for:

Malignancies treated with curative intent and adequate follow-up with no known active disease and have not required active treatment within the past 3 years before the first dose of study intervention and of low potential risk of recurrence.
Adequately resected non melanoma skin cancer or lentigo maligna without evidence of disease .
Adequately treated carcinoma in situ, including Ta tumors without evidence of disease.
Mixed small cell and non-small cell lung cancer histology.
Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia).
Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy.
History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis
Active or prior documented autoimmune or inflammatory disorders (with exceptions)
Active EBV infection, or known or suspected chronic active EBV infection at screening
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

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