Идёт набор NCT07005128

A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)

Фаза III С лечением Small-cell Lung Cancer Extensive Stage 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: Tarlatamab, Durvalumab, Carboplatin, Etoposide.
Кому может быть актуально: Состояния в реестре: Small-cell Lung Cancer, Extensive Stage Small-cell Lung Cancer. Базовые параметры: 18 лет — 99 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, Аргентина, Австралия, Австрия, Бельгия +21
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 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in Combination With Durvalumab, Carboplatin and Etoposide Versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)

Обзор

The main objective of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS).

Вмешательства

Препарат Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Препарат Durvalumab
Durvalumab will be administered as an IV infusion.
Препарат Carboplatin
Carboplatin will be administered as an IV infusion.
Препарат Etoposide
Etoposide will be administered as an IV infusion.

Первичные конечные точки

Overall Survival (OS) [Срок оценки: Up to approximately 3.5 years]
Progression free survival (PFS) (Blinded Independent Central Review [BICR] Assessed) [Срок оценки: Up to approximately 3.5 years]

Вторичные конечные точки (12)

PFS (Investigator Assessed) [Срок оценки: Up to approximately 4 years]
Objective Response (OR) [Срок оценки: Up to approximately 4 years]
Disease Control [Срок оценки: Up to approximately 4 years]
Duration of Response (DOR) [Срок оценки: Up to approximately 4 years]
PFS Rate [Срок оценки: 6 months, 1 year, and 2 years]
OS Rate [Срок оценки: 6 months, 1 year, 2 years and 3 years]
Time to Progression [Срок оценки: Up to approximately 4 years]
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Up to approximately 4 years]
Number of Participants Who Experience Treatment-related Adverse Events [Срок оценки: Up to approximately 4 years]
Number of Participants Who Experience Events of Interest [Срок оценки: Up to approximately 4 years]
Serum Concentrations of Tarlatamab [Срок оценки: Up to approximately 1 year]
Number of Participant Who Develop Anti-Tarlatamab Antibodies [Срок оценки: Up to 13 months]

Критерии участия

Критерии включения

Participant has provided informed consent before initiation of any study-specific activities/procedures.
Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years.
Histologically or cytologically documented ES-SCLC (American Joint Committee on Cancer, 2017, Stage IV SCLC \[T any, N any, M1 a/b/c\]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.
Measurable disease as defined per RECIST 1.1.
Suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment.
Minimum life expectancy ≥ 12 weeks.

Критерии исключения

Participants can have no history of other malignancy in the last 2 years.
Any symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.
They will have no history of severe or life-threatening events to immune-mediated therapy.
History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
They will have no active autoimmune or inflammatory disorders.
Presence of active human immunodeficiency virus (HIV) or active Hepatitis (B/C) infection.
Evidence or interstitial lung disease (ILD) or active, non-infectious pneumonitis.
History of solid organ transplant.
They will not have had a myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment.

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

США · 50 центров

Cancer and Blood Specialists of Arizona — Casa Grande
City of Hope Cancer Center Phoenix — Goodyear
Genesis Cancer Center — Hot Springs
Saint Bernards Medical Center — Jonesboro
Providence Saint Jude Medical Center — Fullerton
Translational Research in Oncology US Inc, Trio Central Pharmacy — Los Angeles
University of California Los Angeles — Santa Monica
Presbyterian Intercommunity Hospital Health Whitter Hospital — Whittier
… и ещё 42 центра

Китай · 17 центров

Beijing Cancer Hospital — Пекин
Beijing Cancer Hospital — Пекин
The Second Attached Hospital Of Fujian Medical University — Quanzhou
Harbin Medical University Cancer Hospital — Харбин
Jiamusi Cancer Hospital — Jiamusi
Henan Cancer Hospital — Чжэнчжоу
Jiangxi Cancer hospital — Nanchang
The First Affiliated Hospital of Nanchang University — Nanchang
… и ещё 9 центров

Япония · 13 центров