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Идёт набор NCT07309211

Durvalumab as Consolidation Therapy in Patients With LS-SCLC Following sCRT

— Наблюдательное SCLC, Limited Stage

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: SCLC, Limited Stage. 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
Китай
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 Multi-centre, Retrospective Study Assessing Durvalumab as Consolidation Treatment for Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC) Following by Sequential Chemoradiotherapy (sCRT)

Обзор

This is a retrospective, multi-centre, single arm study to assess the safety and efficacy of receiving Durvalumab in patients with Small Cell Lung Cancer Limited Stage (LS-SCLC) who have not progressed following sequential chemoradiotherapy (sCRT) in a real-world setting. The study will enroll 25 patients. The primary endpoint of the study is the incidence of Grade 3 or 4 adverse events (AEs) within 6 months of starting Durvalumab (graded by CTCAE v.5.0). The secondary endpoints of the study include real-world progression-free survival (rwPFS, the time from the start of Durvalumab treatment to disease progression or death for any reason, which occurs first), objective response rate (ORR), duration of response (DoR) and disease control rate (DCR). sCRT is more common in Mid-Eastern Chinese clinical practice. sCRT is also recommended in guideline of Chinese Society of Clinical Oncology (CSCO) Small-cell lung cancer. However, patients treated with sCRT were not included in the ADRIATIC study. So there is lack of data on safety and efficacy of Durvalumab post sCRT. Supplement real-world evidence (RWE) clinical data of sCRT in Chinese patients is needed to enhance the status of Durvalumab as a consolidation therapy for LS-SCLC. The study will retrospectively collect cases of eligible LS-SCLC patients who received sCRT and have not progressed followed by receiving Durvalumab as consolidation therapy.

Первичные конечные точки

  • Incidence of Grade 3 or 4 Adverse Events (AEs) within 6 months of starting Durvalumab [graded by Common Terminology Criteria for Adverse Event (CTCAE) v.5.0] [Срок оценки: Within 6 months of starting Durvalumab]
Вторичные конечные точки (4)
  • Real world PFS (rwPFS) [Срок оценки: From date of the first dose of Durvalumab to date of objective disease progression or death, whichever came first, assessed up to 60 months]
  • ORR (Objective response rate from starting with Durvalumab treatment) [Срок оценки: Up to 60 months]
  • DoR (Duration of response from starting with Durvalumab treatment) [Срок оценки: From the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first, Up to 60 months]
  • DCR (Disease control rate from staring with Durvalumab treatment) [Срок оценки: Up to 60 months]

Критерии участия

Критерии включения

  • Aged ≥18 at initial diagnosis;
  • Histological or cytological evidence of LS-SCLC (Stage I-III); Stage I-II must be medically inoperable;
  • Received chemotherapy sequential with radiotherapy as first-line treatment and no progression, followed by receiving Durvalumab at least 1 dose as consolidation treatment until progression, unacceptable toxicity or for a maximum of 24 months;
  • Start Durvalumab treatment within 3 months after sCRT;
  • Permitted PCI;
  • WHO PS 0-2 before sCRT.

Критерии исключения

  • ES-SCLC or mixed SCLC and NSCLC histology;
  • Active or prior documented autoimmune or inflammatory disorders or uncontrolled intercurrent illness;
  • Any unresolved toxicity (CTCAE Grade ≥ 2) from prior chemoradiotherapy; 4. Received concurrent chemoradiotherapy for LS-SCLC.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Китай · 4 центра
  • Cancer Hospital of Shandong First Medical University — Цзинань
  • Nanjing Chest Hospital — Нанкин
  • The First Affiliated Hospital with Nanjing Medical University — Нанкин
  • The affiliated hospital of qingdao university — Qingdao

Идентификаторы

NCT: NCT07309211 · 2025-SR-343.A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗