Phase II Study of Multidisciplinary Therapy using Pembrolizumab for Patients with Synchronous Oligometastatic Stage IV Non-Small Cell Lung Cancer (TRAP OLIGO study) (WJOG11118L) - TRAP OLIGO study

Hirotsugu Kenmotsu0 个研究点目标入组 30 人开始时间: 2020年9月29日最近更新: 2023年10月17日

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方
入组人数: 30

研究概览入排标准研究者记录与标识符相似试验

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 < 75age old（—）
性别: All

入选标准

•Inclusion Criteria:
•1.The age is within 20-75 years.
•2.Histologically confirmed non-small cell lung cancer
•3.No or unknown activating driver mutation: epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), proto-oncogene receptor tyrosine kinase (ROS1), mesenchymal epithelial transition receptor (MET)
•4.Patients who have not received prior systemic chemotherapy
•5.Synchronous oligo-metastatic stage IV disease: maximum of three distant metastases*
•*The metastatic lesions will be counted as follows: each lesion will individually be counted as one, and intrathoracic lymph node involvement (defined here as hilar, mediastinal, or supraclavicular nodes, N1-N3) will collectively be counted as one.
•6.The patient must be a suitable candidate for local therapy (radiotherapy and/or surgery) to every site of disease, as determined by a multidisciplinary tumor board (including specialists in thoracic oncology, radiology, radiotherapy and thoracic surgery).
•7.No malignant ascites, leptomeningeal carcinomatosis and malignant pleural effusion Primary
•8.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
•9.The functions of the main organs are maintained, and all the criteria stated below are satisfied.
•a)WBC >= 1500/mm3
•b)Neutrophil count >= 1,500 /mm3
•c)Hemoglobin: >=9.0 g/dl
•d)Platelet count: >=100,000/mm3
•e)Both AST and ALT: <=100 IU/L
•f)Total bilirubin: <=1.5 mg/dl
•g)Serum creatinine: <=1.5 mg/dl
•h)SpO2: >=92% in the state of no oxygen inhalation (room climate)

排除标准

•1.History of another primary malignancy within 5 years.
•2.Active infection requiring therapy.
•3.Active Hepatitis B or C.
•4.Active autoimmune disease that has required systemic treatment
•5.Unsuitable for thoracic radiotherapy by interstitial lung disease or chronic obstructive lung disease
•6.Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results.

研究者

发起方

Hirotsugu Kenmotsu

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