JPRN-jRCTs031200319进行中（未招募）2 期
A phase II study of carboplatin and etopside plus durvalumab for previously-untreated extensive-stage small-cell lung cancer (ES-ECLC) patients with poor performance status (PS) - NEJ045A
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Extensive stage small cell lung cancer proven by histology and/or cytology without indication of curative surgery or curative radiotherapy, 2) No prior cytotoxic chemotherapy or immunotherapy, 3) ECOG PS 2 or 3, 4) 20 years or older, 5)Measurable disease, as defined by RECIST ver 1.1, 6) adequate hematologic and end organ function,7) Written informed consent form.
排除标准
- •1) History of interstitial lung disease, 2) Symptomatic CNS metastases, CNS metastases treated with corticosteroids, leptomeningeal disease, 3) Irradiation for primary tumor or target lesion defined by RECIST ver1.1, 4) Uncontrolled heart, lung, liver, renal diseases, 5) History of autoimmune diseases or immunodeficiency, 6) Patients with active hepatitis B or hepatitis C or positive for HIV test, 7) Men without an intention to use the measure for contraception or women who are pregnant, lactating, or intending to become pregnant during the study, 8) Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, 9) Malignancies other than NSCLC within 5 years, 10) Systemic steroid administration at a dose of more than 10 mg of prednisolone for 4 weeks or longer.
研究者
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