JPRN-jRCTs071210050进行中（未招募）2 期
A Phase II study of Durvalumab (MEDI4736) plus carboplatin and etoposide in elderly patients with extensive-stage small-cell lung cancer - LOGIK2003 (Turtle study)
Koichi Azuma0 个研究点目标入组 40 人开始时间: 2021年8月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- >= 75age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Histologically or cytologically confirmed small-cell lung cancer
- •2) Extensive-stage (ES)-SCLC
- •3) No prior systemic chemotherapy for ES-SCLC
- •4) 75 years of age or older
- •5) ECOG performance status of 0 to 1
- •6) With measurable lesions according to the RECIST criteria version 1.1
- •7) Written informed consent
- •8) Expected to survive for 12 weeks or longer
- •9) Body weight > 30kg
排除标准
- •1) Synchronous or metachronous (within a year) malignancies
- •2) Active infection requiring systemic therapy and/or surgical procedures such as drainage
- •3) Active hepatitis B and C, and active tuberculosis
- •4) Interstitial lung disease on CT
- •5) Active autoimmune or inflammatory disease, or the history of autoimmune disease
- •6) Administration of immunosuppressants within 14 days prior to the protocol treatment
- •7) Grade2 or worse complications
- •8) Uncontrolled complications
- •9) Surgical treatment with general anesthesia within 14 days prior to the registration
研究者
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