Идёт набор NCT06494540

NIS to Examine the Effectiveness of TDC in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations

— Наблюдательное Non-squamous Metastatic Non-Small-Cell Lung Carcinoma

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: Non-squamous Metastatic Non-Small-Cell Lung Carcinoma. Базовые параметры: 18 лет — 120 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: Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Prospective Non-interventional Study (NIS) to Examine the Effectiveness of Tremelimumab + Durvalumab + Platinum Chemotherapy (TDC) in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations

Обзор

This prospective, multicenter, non-interventional study (NIS) in Germany aims to collect real-life data of patients with non-squamous (NSQ) metastatic non-small cell lung cancer (mNSCLC) (incl. large cell neuroendocrine carcinoma (LCNEC) if considered NSCLC-like by the treating physician) for whom 1st line treatment initiation with tremelimumab and durvalumab in combination with a platinum-based chemotherapy (TDC) according to marketing authorization was scheduled. The study aims to describe the effectiveness with respect to mutations in Kirsten rat sarcoma viral oncogene homolog (KRAS), Serine/threonine kinase 11 (STK11), Kelch-like ECH-associated protein 1 (KEAP1), and Tumor protein p53 (TP53) as well as expression of Thyroid transcription factor 1 (TTF-1) and Programmed death-ligand 1 (PD-L1) in routine clinical practice. The generated data aims to deepen the understanding of optimal, biomarker-guided treatment strategies for NSQ mNSCLC in distinct subgroups with a high medical need.

Первичные конечные точки

Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in the total study population [Срок оценки: Time from patient's index date until death by any cause, up to 24 months]
Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in patients with mutations in KRAS [Срок оценки: Time from patient's index date until death by any cause, up to 24 months]
Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in patients with mutations in STK11 [Срок оценки: Time from patient's index date until death by any cause, up to 24 months]

Вторичные конечные точки (10)

Real-world overall survival (rwOS) in the total study population [Срок оценки: 6, 12 and 18 months]
Median overall survival (mOS) in the total study population [Срок оценки: up to 24 months]
Real-world overall survival (rwOS) in a subgroup of patients with mutation in KRAS [Срок оценки: 6, 12 and 18 months]
Median overall survival (mOS) in a subgroup of patients with mutation in KRAS [Срок оценки: up to 24 months]
Real-world overall survival (rwOS) in a subgroup of patients with mutation in STK11 [Срок оценки: 6, 12 and 18 months]
Median overall survival (mOS) in a subgroup of patients with mutation in STK11 [Срок оценки: up to 24 months]
Real-world treatment response of TDC, as judged by the treating physician [Срок оценки: up to 24 months]
Duration of response (DoR) [Срок оценки: up to 24 months]
Real-world progression-free survival (rwPFS) [Срок оценки: up to 24 months]
Safety: Collection of Adverse Events (AE) [Срок оценки: up to 24 months]

Критерии участия

Критерии включения

Aged ≥ 18 years
Decision to start first-line (1L) treatment with TDC according to the current SmPCs
Histologically or cytologically confirmed diagnosis of NSQ mNSCLC (incl. LCNEC if considered NSCLC-like by the treating physician)
No sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) alterations
Molecular Next Generation Sequencing (NGS) panel as per institutional standard has been initiated (including the following genes: KRAS, STK11, KEAP1, and TP53)
TTF-1 expression analysis has been initiated
PD-L1 expression analysis has been initiated
Women of childbearing potential must use effective contraception during treatment with durvalumab and for at least 3 months after the last dose of durvalumab
Ability to understand the study concept
Provision of signed informed consent form in accordance with applicable local provisions