A Multicenter Phase II Trial of Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in Homologous Recombination Deficiency (HRD) Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC)
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Maintenance durvalumab (MEDI4736) and olaparib (AZD2281) after standard 1st line treatment (carboplatin/ cisplatin, etoposide, durvalumab) in HRD positive extensive disease (ED) small-cell lung cancer (SCLC)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Combination of olaparib and durvalumab after four cycles of standard 1st line treatment
Study treatment (olaparib and durvalumab) starts with the initiation of maintenance therapy and is administered at a 28-day cycle until progression, unacceptable toxicity, or discontinuation for other reasons.
Induction therapy (four cycles of carboplatin/cisplatin, etoposide, durvalumab (the administration of one induction cycle without durvalumab is permitted)) is administered as part of standard of care.
干预措施: Durvalumab (Drug)
Combination of olaparib and durvalumab after four cycles of standard 1st line treatment
Study treatment (olaparib and durvalumab) starts with the initiation of maintenance therapy and is administered at a 28-day cycle until progression, unacceptable toxicity, or discontinuation for other reasons.
Induction therapy (four cycles of carboplatin/cisplatin, etoposide, durvalumab (the administration of one induction cycle without durvalumab is permitted)) is administered as part of standard of care.
干预措施: Olaparib (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Approximately two years (from First patient in (FSI) to Last patient last visit (LSLV))
PFS according to investigator-assessed RECIST 1.1 from start of maintenance therapy
次要结局
- ORR of maintenance.(Approximately two years (from FSI to LSLV))
- Incidence, severity and grading of adverse events (AE) and seriouse adverse events (SAE).(Approximately two years (from FSI to LSLV))
研究者
Prof. Dr. Juergen Wolf
Clinical Prof. Dr. Jürgen Wolf
University of Cologne