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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- 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]
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •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.
排除标准
- •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;
- •Received concurrent chemoradiotherapy for LS-SCLC.
结局指标
主要结局
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]
时间窗: Within 6 months of starting Durvalumab
次要结局
- Real world PFS (rwPFS)(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)(Up to 60 months)
- DoR (Duration of response from starting with Durvalumab treatment)(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)(Up to 60 months)
研究者
Xin Zhao
Chief Physician
The First Affiliated Hospital with Nanjing Medical University