TRIMPACT: Real-World First-Line Atezolizumab Use in Stage IV NSCLC With PD-L1 ≥50%
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: NSCLC Stage IV, PD-L1 Gene Mutation, Atezolizumab, Real World Study. 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
- Turkey (Türkiye)
- 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
TRIMPACT: A Prospective Real-World Study of Atezolizumab Monotherapy as First-Line (Stage IV) Treatment in Patients With Non-Small Cell Lung Cancer With PD-L1 Tumor Cell Expression ≥50% and No Targetable Mutations
Обзор
This prospective, multicenter, real-world observational study aims to evaluate the clinical outcomes of first-line atezolizumab monotherapy in patients with stage IV non-small cell lung cancer (NSCLC) with PD-L1 tumor cell expression ≥50% and no targetable mutations. The study aim to determine how atezolizumab performs in routine clinical practice with respect to survival, treatment response, and safety outcomes in this patient population in Türkiye.
Подробное описание
This study is a prospective, multicenter, observational study designed to generate real-world evidence on the routine first-line use of atezolizumab in patients with advanced non-small cell lung cancer (NSCLC) who exhibit high PD-L1 expression and have no targetable mutations. The study does not impose any protocol-mandated procedures or intervention requirements, and all assessments, treatments, and follow-up visits are carried out according to local standards of care at each participating center.
Data will be collected prospectively from routine medical records and will include information typically obtained during standard clinical management, such as imaging assessments, laboratory results, performance status evaluations, treatment exposure, and safety monitoring. Clinical outcomes will be analyzed to describe real-world treatment patterns, variations in clinical practice, and survival and safety trends in a national cohort. Approximately 150 patients are expected to be enrolled to ensure adequate precision in estimating long-term outcomes within this population.
Первичные конечные точки
- Overall Survival (OS) [Срок оценки: Up to 24 months]
Вторичные конечные точки (7)
- Progression-Free Survival (PFS) [Срок оценки: Up to 24 months]
- Objective Response Rate (ORR) [Срок оценки: Up to 24 months]
- Disease Control Rate (DCR) [Срок оценки: Up to 24 months]
- Duration of Response (DoR) [Срок оценки: Up to 24 months]
- One-year Overall Survival (1-year OS) [Срок оценки: 12 months]
- Incidence of Hyperprogression [Срок оценки: Up to 24 months]
- Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) [Срок оценки: Up to 24 months]
Критерии участия
Критерии включения
- Signed informed consent form.
- Diagnosis of stage IV non-small cell lung cancer.
- Male or female patients aged 18 years or older.
- Patients who have been prescribed atezolizumab in accordance with routine clinical practice and the locally approved indication in Türkiye.
- Patients who have received up to 3 cycles of atezolizumab at the screening visit.
Критерии исключения
- Patients who are not receiving atezolizumab for the treatment of lung cancer according to standard of care and the approved indication.
- Known or suspected hypersensitivity to atezolizumab.
- Pregnant or breastfeeding women.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Turkey (Türkiye) · 25 центров
- Adana City Hospital — Adana
- Afyonkarahisar Health Sciences University Hospital — Afyonkarahisar
- Ankara Oncology Training and Research Hospital — Ankara
- Memorial Ankara Hospital — Ankara
- Ankara Bilkent City Hospital — Ankara
- Ankara Atatürk Sanatoryum Training and Research Hospital — Ankara
- Antalya Training and Research Hospital — Antalya
- Antalya City Hospital — Antalya
- … и ещё 17 центров
Идентификаторы
NCT: NCT07279402 · MON1068.1.82