EUCTR2019-004284-51-NL进行中（未招募）1 期
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 人开始时间: 2020年4月14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
- 10
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
- •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.
- •Females of childbearing potential must use reliable methods of contraception from the time of screening until 3 months after discontinuing study treatment. Acceptable methods of contraception include total sexual abstinence, tubal ligation, hormonal contraceptives that are not prone to drug-drug interactions, copper-banded intra-uterine devices and vasectomised partner. All methods of contraception must be used in combination with the use of a condom by their male sexual partners for intercourse.
- •Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
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
- •b.Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- •c.Any chronic skin condition that does not require systemic therapy
- •d.Patients without active disease in the last year may be included but only after consultation with the study physician
- •e.Patients with celiac disease controlled by diet alone.
- •Active infection as judged to be unacceptable by the treating physician in the context of cCRT.
- •History of active primary immunodeficiency.
- •Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
- •a.Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- •b.Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- •c.Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
- •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, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
- •History of another primary malignancy except for
- •a.Malignancy treated with curative intent and with no known active disease =2 years before the
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