EUCTR2018-003011-22-ES进行中（未招募）1 期
A multicentre single arm phase II trial assessing the efficacy of immunotherapy, chemotherapy and stereotactic radiotherapy to metastases followed by definitive surgery or radiotherapy to the primary tumour, in patients with synchronous oligo-metastatic nonsmall cell lung cancer - CHESS
ETOP (European Thoracic Oncology Platform)0 个研究点目标入组 47 人开始时间: 2019年7月5日最近更新:
适应症
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
- 47
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
入选标准
- •- Histological confirmed NSCLC
- •- Synchronous oligo-metastatic stage IV disease (max 3 distant metastases, one of which must be extra-cerebral for SBRT)
- •- Neurosurgical resection of one single CNS metastasis or laparoscopic
- •resection of one adrenal metastasis before study inclusion is allowed (one
- •extra-cerebral metastass must be available for SBRT)
- •- Able to understand and give written informed consent and comply with study procedures
- •- Age =18 years
- •- ECOG 0-1
- •- Availability of tumour tissue for translational research
- •- Adequate haematological, renal and liver function
- •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 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Prior chemotherapy, radiotherapy or surgery for NSCLC
- •- Activating driver mutation: EGRF, ALK, ROS1
- •- >3 distant metastases
- •- Brain metastases not amendable for radiosurgery or neurosurgery
- •- Extracranial metastatic locations such as malignant ascites, pleural or pericardial
- •effusion, diffuse lymphangitiosis of skin or lung, diffuse bone marrow metastasis, abdominal masses/abdominal organomegaly, identified by physical exam that is not
- •measurable by reproducible imaging techniques.
- •- Primary lung cancer not suitable for radical therapy (pneumonectomy excluded)
- •- History of leptomeningeal carcinomatosis
- •- Major surgery or significant traumatic injury from which the patient has not
- •recovered at least 28 days before enrolment
- •- Any uncontrolled intercurrent illness, including but not limited to: ongoing or active
- •infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
- •angina pectoris, cardiac arrhythmia, interstitial lung disease or serious chronic gastrointestinal conditions associated with diarrhea, which in the investigator’s
- •opinion makes it undesirable for the patient to participate in the trial or which would
- •jeopardise compliance with the protocol
- •- Active tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- •- Active autoimmune disease requiring systemic treatment
- •- Severe or uncontrolled cardiac disease requiring treatment
- •- History of primary immunodeficiency
- •- History of allogeneic organ transplant
- •- Receipt of live attenuated vaccines within 30 days prior to enrolment
- •- Known allergies or hypersensitivity to trial drugs or to any excipient.
- •- Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the trial and for up to 90 days after last dose of durvalumab.
研究者
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