JPRN-jRCT2080223579已完成3 期
A Phase 3, Randomized, Multicenter,Open-Label, Comparative Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for the First-Line Treatment in Patients With Extensive Disease (Stage IV) Small-Cell Lung Cancer (SCLC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 53
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 130age old（—）
- 性别
- All
入选标准
- •1. Histologically or cytologically documented extensive disease. Brain metastases; must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment.
- •2. Suitable to receive a platinum-based chemotherapy regimen as 1st line treatment.
- •3. Life expectancy 12 weeks or more at Day 1.
- •4. ECOG 0 or 1 at enrolment.
- •5. No prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines.
排除标准
- •1. Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy (except paliative care outside of the chest).
- •2. Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical symptomatology suggesting worsening of PNS.
- •3. Active infection including tuberculosis, HIV, hepatitis B anc C.
- •4. Active or prior documented autoimmune or inflammatory disorders.
- •5. Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
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