2024-511887-10-00招募中2 期
A Phase II Multicenter, Open-Label, Single Arm Study to Determine the Efficacy, Safety and Tolerability of AZD2811 and Durvalumab Combination as Maintenance Therapy After Induction with Platinum-Based Chemotherapy Combined with Durvalumab, for the First-Line Treatment of Patients with Extensive Stage Small-Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Maintenance participants alive and progression free (APF12)
研究概览
简要总结
To evaluate the efficacy of AZD2811 + durvalumab by assessment of the proportion of participants alive and progression free at 12 months (APF12) who have not progressed during EP-durvalumab based induction therapy
研究设计
- 分配方式
- Non-randomized
- 主要目的
- D6132c00001
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Documented evidence of extensive stage SCLC (ES-SCLC)
- •Participants must be considered suitable to receive a platinum-based chemotherapy regimen, combined with durvalumab, as first-line treatment for ES-SCLC
- •No prior exposure to immune-mediated therapy
- •Life expectancy ≥12 weeks
- •ECOG 0 or 1 at enrolment
排除标准
- •Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy
- •Has a paraneoplastic syndrome (PNS) of autoimmune systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS
- •Active infection including tuberculosis, HIV, hepatitis B and C
- •Active or prior documented autoimmune or inflammatory disorders
- •Uncontrolled intercurrent illness, including but not limited to interstitial lung disease
结局指标
主要结局
Maintenance participants alive and progression free (APF12)
Maintenance participants alive and progression free (APF12)
次要结局
- Maintenance participants alive at 12 months (OS12), 15 months (OS15), and 18 months (OS18)
- Maintenance participants alive and progression free at 6 months (APF6) and 9 months (APF9) using investigator assessments according to RECIST 1.1
- Objective response rate (ORR) for all participants using investigator assessments according to RECIST 1.1
- Maintenance participants Progression-free survival (PFS) using investigator assessments according to RECIST 1.1
- Overall survival (OS) in maintenance participants
- The safety and tolerability profile of study intervention in SCLC
- The pharmacokinetics of durvalumab and AZD2811
- Disease-related symptoms & Health-related QoL measured by EORTC QLQ-LC30 & EORTC QLQ-LC13
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (1)
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