EUCTR2020-004091-18-PL进行中（未招募）1 期
A Phase II Multicenter, Open-Label, Single Arm Study toDetermine the Efficacy, Safety and Tolerability of AZD2811 andDurvalumab Combination as Maintenance Therapy AfterInduction with Platinum-Based Chemotherapy Combined withDurvalumab, for the First-Line Treatment of Patients withExtensive Stage Small-Cell Lung Cancer. - TAZMA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 at Day 1.
- •ECOG 0 or 1 at enrolment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
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.
研究者
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