2024-517937-41-00招募中2 期
Durvalumab (MEDI4736) in combination with consolidative radiochemotherapy and ablative stereotactic radiotherapy in extensive stage SCLC
Universitaet Des Saarlandes10 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2024年10月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 43
- 试验地点
- 10
- 主要终点
- One-year progression-free survival (PFS) rate using investigator assessments according to RECIST 1.1
研究概览
简要总结
- To prove feasibility of a treatment scheme consisting of thoracic radiotherapy concomitant to platinum/etoposide/durvalumab therapy followed by stereotactic radiotherapy concomitant to durvalumab maintenance.
- To study the efficacy of this treatment scheme to improve the PFS rate at 12 months.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed first diagnosis of ES-SCLC according to the Veterans Administration Lung Study Group (VALG) Staging System for SCLC.
- •Oligometastatic disease defined as follows: Primary tumor with or without mediastinal or supraclavicular lymph node metastases. Up to four distant tumor lesions/metastases that can be treated with stereotactic radiotherapy. No cytologically confirmed malignant pleural effusion.
- •Stable disease (SD) or partial response (PR) according to RECIST 1.1 criteria after previous treatment with two cycles of platinum/etoposide/durvalumab.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Must have a life expectancy of at least 12 weeks.
排除标准
- •Prior systemic anticancer therapy (chemotherapy, immunotherapy, targeted therapy), apart from two cycles of etoposide/platinum + durvalumab
- •Any unresolved toxicity NCI CTCAE Grade ≥2 from previous chemo-immunotherapy
- •Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
- •Major surgical procedure within 28 days prior to the first dose of IP.
- •Active or prior documented autoimmune or inflammatory disorders
- •Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
- •Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
结局指标
主要结局
One-year progression-free survival (PFS) rate using investigator assessments according to RECIST 1.1
One-year progression-free survival (PFS) rate using investigator assessments according to RECIST 1.1
次要结局
未报告次要终点
研究者
Prof. Dr. Markus Hecht
Scientific
Universitaet Des Saarlandes
研究点 (10)
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