EUCTR2017-004572-62-DK进行中（未招募）1 期
A randomized phase II study comparing atezolizumab after concurrent chemo-radiotherapy with chemo-radiotherapy alone in limited disease small-cell lung cancer - ACHILES
orwegian University of Science and Technology, Department of Clinical and molecular medicine0 个研究点目标入组 212 人开始时间: 2018年6月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 212
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
- •1.Histologically or cytologically confirmed small-cell lung cancer
- •2.No prior systemic therapy for SCLC or immune checkpoint blockade therapy
- •3.Previous radiotherapy to the thorax is allowed as long as the patient can receive TRT of 45 Gy. If it later turns out that 45 Gy cannot be administered, the patient should be excluded.
- •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.Age = 18 years
- •6.ECOG performance status 0-2
- •7.Measureable disease according to the RECIST 1.1
- •8.Adequate organ function defined as:
- •a.Serum alanine transaminase (ALT) = 2.5 x upper limit of normal (ULN)
- •b.Total serum bilirubin = 1.5 x ULN
- •c.Absolute neutrophil count (ANC) = 1.5 x 109/L
- •d.Platelets = 100 x 109/L
- •e.Creatinine < 100 µmol/L and calculated creatinine-clearance > 50 ml/min. If calculated creatinine-clearance is < 50 ml/min, an EDTA clearance should be performed.
- •9.No malignant cells in pericardial or pleural fluid (at least 1 sample should be obtained if pleural fluid is present) If there is so little fluid that it cannot easily be collected, the patient is considered eligible.
- •10.Pulmonary function: FEV1 > 1 l or > 30 % of predicted value and DLCO > 30 % of predicted value
- •11.All fertile patients should use safe contraception
- •12.Written informed consent
- •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 106
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 106
排除标准
- •11.Any serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) that in the opinion of the investigator would compromise the patient’s ability to complete the study or interfere with the evaluation of the efficacy and safety of the study treatment
- •12.Any autoimmune or lung disease requiring systemic steroids in doses of >10 mg prednisolone (or equivalent dose of other steroid)
- •13.Any previous allogeneic or organ transplant
- •14.Any active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis
- •15.Any history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- •16.Any live vaccine last 30 days, active infection requiring IV antibiotics, no active viral hepatitis or HIV-positive
- •17.Any conditions – medical, social, psychological – which could prevent adequate information and follow-up
- •18.Any clinically active cancer other than SCLC with the exception of malignancies with a negligible risk of metastases or death (e.g. 5-years OS rate of >90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer. Hormonal therapy for non-metastatic prostate or breast cancer is allowed.
- •19.Pregnancy or lactating women
研究者
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