NL-OMON55251已完成不适用
An exploratory study of durvalumab (MEDI4736) uptake during concurrent chemoradiotherapy in stage III NSCLC patients using 89Zr-labeled durvalumab PET - CONDOR
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
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
- •* 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.
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
- 另有 3 项未显示
研究者
相似试验
进行中（未招募）
1 期
Does immunotherapy (durvalumab) accumulate in the tumors of patients with lung cancer receiving chemotherapy together with radiotherapy.EUCTR2019-004284-51-NLAmsterdam UMC, VU University Medical Center10
进行中（未招募）
1 期
Treatment of patients with HIV-1 and advanced solid tumors with Durvalumabadvanced solid tumors in HIV-1 infected patientsEUCTR2016-004524-38-ESSpanish Lung Cancer Group (Grupo Español de Cáncer de Pulmón)20
暂停
1 期
A phase Ib study of durvalumab (MEDI4736) tremelimumab combined with particle therapy in advanced hepatocellular carcinoma patients with macrovascular invasiohepatocellular carcinomaJPRN-jRCT2031210046Ogasawara Sadahisa15
进行中（未招募）
1 期
A phase Ib/II study of Durvalumab (MEDI4736) combined with dose-dense EC in a neoadjuvant setting for patients with locally advanced luminal B HER2(-) or triple negative breast cancers (B-IMMUNE)patients with locally advanced luminal B HER2(-) or triple negative breast cancers (B-IMMUNE)EUCTR2016-003998-17-BEGrand Hôpital de Charleroi57
招募中
不适用
Phase II, single-arm study of durvalumab (MEDI4736) and AZD 6738 combination therapy in relapsed small cell lung cancer SubjectsKCT0005058Samsung Medical Center45