Durvalumab Consolidation After Chemoradiation Therapy for Limited Stage SCLC in China

Официальное название

Durvalumab Consolidation After Chemoradiation Therapy (CRT) for Patients With Limited Stage Small-Cell Lung Cancer in China: A Multicentre, Observational Study (DREAM)

Обзор

This prospective, multicentre, observational study aims to assess the effectiveness and safety of durvalumab as consolidation treatment for patients with LS-SCLC who have not progressed following CRT in real-world setting.

Подробное описание

In this study, the effectiveness and safety profile of durvalumab consolidation following CRT in patients with LS-SCLC will be investigated in a real-world setting. Clinical outcomes will be explored across different CRT modalities and regimens according to local practice. Additionally, evidence will be generated on durvalumab consolidation following CRT regardless of concurrent or sequential setting. The subsequent treatment patterns of patients who experience disease progression during or after durvalumab consolidation will also be evaluated.

Первичные конечные точки

• rwPFS [Срок оценки: From 3 months before enrolment to follow-up of up to 36 months]

Вторичные конечные точки (2)

• TTD [Срок оценки: From 3 months before enrolment to follow-up of up to 36 months]
• OS [Срок оценки: From 3 months before enrolment to follow-up of up to 36 months]

Критерии участия

Критерии включения

• Able to provide informed consent
• Age ≥18 years
• Histologically or cytologically documented LS-SCLC (Stage I-III SCLC \[T any, N any, M0\] according to the American Joint Committee on Cancer Staging Manual \[AJCC Cancer Staging Manual, 8th Edition\], that can be safely treated with definitive radiation doses. Excludes T3-4 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)
• ECOG PS 0-2 (prior to the first dose of durvalumab after CRT)
• No disease progression following cCRT/sCRT (cCRT refers to chemotherapy and radiotherapy are administered with overlap; sCRT refers to chemotherapy and radiotherapy are delivered in a sequential manner with no overlap)
• Patients who received platinum-based cCRT/sCRT followed by durvalumab consolidation as first-line treatment at the discretion of physicians are eligible (the time interval from the end of cCRT/sCRT to the first dose of durvalumab consolidation should be within 3 months)

• Patients who started durvalumab consolidation ≤3 months before enrolment in the study will be allowed (irrespective of whether they continue to receive durvalumab at time of enrolment or already discontinued treatment)

Критерии исключения

• Patients treated with CRT only without subsequent durvalumab consolidation
• Patients received durvalumab or any other anti-PD-1/anti-PD-L1 antibodies along with CRT
• Patients who previously were involved, or currently are, or plan to be involved in any other interventional anti-cancer clinical studies for LS-SCLC
• Prior exposure to immune-mediated therapy including, but not limited to, other anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines
• Judgment by the investigator that the patient should not participate in the study because the patient is unlikely to comply with study procedures

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 21 центр

• Research Site — Пекин
• Research Site — Cangzhou
• Research Site — Дунгуань
• Research Site — Фучжоу
• Research Site — Гуанчжоу
• Research Site — Huzhou
• Research Site — Цзинань
• Research Site — Цзинань
• … и ещё 13 центров

Идентификаторы

NCT: NCT07161388 · D419QR00019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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