An exploratory study of durvalumab (MEDI4736) uptake during concurrent chemoradiotherapy in stage III NSCLC patients using 89Zr-labeled durvalumab PET - CONDOR

Amsterdam UMC, VU University Medical Center0 个研究点目标入组 10 人2020年4月14日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Amsterdam UMC, VU University Medical Center
入组人数: 10
状态: 进行中（未招募）
最后更新: 4年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2020年4月14日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Amsterdam UMC, VU University Medical Center

入排标准

入选标准

•Have a histologically or cytologically confirmed diagnosis of thoracic disease stage III NSCLC and planned to receive concurrent chemotherapy and radiotherapy on the thorax.
•Patients with oligometastatic stage IV comprising a thoracic stage III and up to 2 distant metastases amenable for radical local consolidative therapy are also eligible.
•Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
•Written informed consent obtained from the subject prior to performing any protocol\-related procedures, including screening evaluations.
•Age \> 18 years at time of study entry.
•Have a World Health Organisation (WHO) performance status of 0 or 1\.
•Life expectancy of \> 3 months.
•Have measurable disease based on RECIST 1\.1\.
•Must consent to allow use of PD\-L1 measurements obtained from tumor biopsies.
•Adequate organ and bone marrow function, as deemed acceptable by the treating physician in the context of cCRT.

排除标准

•Concurrent enrolment in another clinical study, unless it is an observational (non\-interventional) clinical study, or during the follow\-up period of an interventional study.
•Participation in another clinical study with an investigational product during the last 4 weeks.
•Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) \= 30 days prior to the first dose of study drug If sufficient wash\-out time has not occurred due to the schedule or PK properties of an agent, a longer wash\-out period will be required, as agreed by AstraZeneca/MedImmune and the investigator.
•Any unresolved toxicity NCI CTCAE Grade \=2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
•Patients with Grade \=2 neuropathy will be evaluated on a case\-by\-case basis after consultation with the Study Physician.
•Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
•Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Limited surgical excision of isolated lesions for palliative or diagnostic reasons is acceptable.
•History of allogenic organ transplantation.
•Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease], diverticulitis \[with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
•a.Patients with vitiligo or alopecia