Durvalumab Consolidation After Chemoradiation Therapy (CRT) for Patients With Limited Stage Small-Cell Lung Cancer in China: A Multicentre, Observational Study (DREAM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 200
- 试验地点
- 21
- 主要终点
- rwPFS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
LS-SCLC
Patients with LS-SCLC who received platinum-based cCRT/sCRT followed by durvalumab consolidation as first line treatment at the discretion of physicians.
结局指标
主要结局
rwPFS
时间窗: From 3 months before enrolment to follow-up of up to 36 months
From date of first dose of durvalumab consolidation treatment until progression as assessed in real-world, or death due to any cause. The primary measure of interest is the median rwPFS.
次要结局
- TTD(From 3 months before enrolment to follow-up of up to 36 months)
- OS(From 3 months before enrolment to follow-up of up to 36 months)