NL-OMON49619招募中2 期
A randomized phase II study comparing atezolizumab after concurrent chemo-radiotherapy with chemo-radiotherapy alone in limited disease small-cell lung cancer (ACHILES study) - ACHILES
orwegian University of Science and Technology0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age >= 18 years.
- •2. Histologically or cytologically confirmed SCLC
- •3. Previous radiotherapy to the thorax is allowed as long as the patient can
- •receive TRT of 45-60 Gy.
- •4. Stage I-III according to TNM v8, ineligible for surgery provided all lesions
- •can be included in a tolerable radiotherapy field (*limited disease*).
- •5. ECOG performance status 0-2.
- •6. Measureable disease.
- •7. Adequate organ function. See protocol chapter 5 for details.
- •8. FEV1 > 1 L or > 30 % of predicted value and DLCO > 30 % of predicted value.
- •9. Female patients of childbearing potential should use highly effective
- •contraception. See protocol chapter 5 for details.
排除标准
- •1. Prior systemic therapy for SCLC or immune checkpoint blockade therapy.
- •2. Malignant cells in pericardial or pleural fluid. See protocol chapter 5 for
- •3. Serious concomitant systemic disorders. See protocol chapter 5 for details.
- •4. Lung disease requiring systemic steroids in doses of >10 mg prednisolone (or
- •equivalent dose of other steroid).
- •5. Previous allogeneic or organ transplant.
- •6. Active or history of autoimmune disease or immune deficiency. See protocol
- •chapter 5 for details.
- •7. History of certain lung diseases. See protocol chapter 5 for details.
- •8. Live vaccine administered last 30 days, active infection requiring IV
- •antibiotics, active viral hepatitis or HIV.
- •9. Pregnancy or lactation
研究者
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