jRCT1031210706招募中不适用
Verification study for stratification marker of immune checkpoint inhibitor in patients with advanced or recurrent non-small cell lung cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 主要终点
- overall survival
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients with pathologically or cytologically diagnosed, advanced (Stage III or IV)or recurrent non-small-cell lung cancer
- •Patients scheduled to receive anti-PD-1/PD-L1 antibody treatment with or without combination chemotherapy or anti-CTLA-4 antibody treatment
- •Patients over 20 years old with written informed consent
- •Patients with ECOG PS 0-2
- •Patients with measurable target lesions for response evaluation with RECIST(Ver1.1)
- •Patients expected to survive more than 12 weeks after treatment initiation.
排除标准
- •Patients with the past history of immunological treatments (anti-PD-1/PD-L1 antibody therapy, anti-CTLA-4 antibody therapy, cancer vaccines, or immune cell therapy)
- •Patients with regular use of amino acid formulations (as intravenous or enteral nutrition) or supplements, excluding anamorelin
- •Patients with presumed abnormalities of amino acid metabolism, such as liver cirrhosis, renal failure, inborn error of amino acid metabolism, pregnancy, and feeding
- •Patients enrolled in other clinical trials on novel anti-cancer agents or treatment regimens
- •Patients with active double cancer [synchronic double cancer or asynchronous double cancer with no more than 5-year disease-free period, excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured by local treatment]
- •Patients who have brain metastases with clinical symptoms and require administration of corticosteroids (at doses equivalent to, or exceeding, prednisolone 5 mg daily) or antihydropic
- •Patients with poorly controlled pleural effusion, ascites, or pericardial effusion
- •Patients with severe infections or complications
- •Patients with other inappropriate conditions for enrollment judged by the clinicians
结局指标
主要结局
overall survival
Evaluation of overall survival between good and poor subgroups by multivariate discriminant models (3 types) in patients treated with anti-PD-1/PL-L1 antibody with combined chemotherapy (cohort A)
次要结局
- Evaluation of overall survival between subgroups stratified by multivariate discriminant models
- Evaluation of the effects of various factors on overall survival prediction by multivariate discriminant models
研究者
相似试验
已完成
不适用
Validation of novel diagnostic marker of lung squamous cell carcinoma by using detection of urinary protein fragment: a multicenter studyung squamous cell carcinomaJPRN-UMIN000030957niversity of Miyazaki190
尚未招募
不适用
ongitudinal analysis of lung cancer-specific immunity in stage III and IV non-small cell lung cancer patients10038666non-small cell lung cancerNL-OMON37300Antoni van Leeuwenhoek Ziekenhuis50
招募中
2 期
Immune profiling of stage III non-small cell lung cancer patients treated with concurrent chemoradiation and adjuvant durvalumab: A prospective observational phase II trialimmune changes1003866610029107non-small cell lung cancerNL-OMON52550MAASTRO clinic120
已完成
不适用
Validation of novel diagnostic marker of lung adenocarcinoma by using detection of urinary protein fragment: a multicenter studyung adenocarcinomaJPRN-UMIN000030956niversity of Miyazaki190
招募中
不适用
ongitudinal analysis of lung cancer-specific immunity in stage III and IV non-small cell lung cancer patients.NL-OMON25535Stichting Het Nederlands Kanker Instituut - Antoni van Leeuwenhoek ZiekenhuisAmsterdam, The Netherlands50