EUCTR2019-004336-31-IT进行中（未招募）1 期
A Phase II, Open-label, Multicenter, International Study of Durvalumab following Radiation Therapy in patients with stage III, unresectable NonSmall Cell Lung Cancer Who Are Ineligible for Chemotherapy (DUART) - DUART
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •Informed consent as detailed in the protocol.
- •- 18 years or older at the time of signing the ICF.
- •- Histologically-or cytologically-documented NSCLC with locally-
- •advanced, unresectable Stage III disease (according to the IASLC
- •Staging Manual Version 8 [IASLC 2016]).
- •(a) Imaging to rule out distant metastasis is required.
- •(b) Endobronchial ultrasound with biopsy is encouraged in patients with suspected lymph node involvement.
- •- Deemed ineligible for chemotherapy per Investigator assessment (eg, comorbidities, poor PS, etc).
- •- Receipt of radiation therapy that was completed within 42 days prior tofirst IP dose administration in the study.
- •- Patients must have received a total dose of radiation of 40 to 66 Gy
- •(standard or hypofractionated BED). Further details are provided in the protocol.
- •- Patients must not have progressed following radiation therapy, as per Investigator assessed RECIST 1.1 criteria as defined in the protocol.
- •- WHO/ECOG PS of < = 2.
- •- No prior exposure to immune-mediated therapy including, but not
- •limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, and antiprogrammed cell death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
- •- Adequate organ and marrow function as defined in the protocol.
- •- Must have a life expectancy of at least 12 weeks.
- •- Body weight > 30 kg at enrollment and first IP dose administration
- •- Male or female
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •-Patients with locally-advanced NSCLC whose disease has progressed.
- •following radiation therapy.
- •- Mixed small cell lung cancer and NSCLC histology.
- •- History of allogeneic organ transplantation.
- •- Active or prior documented autoimmune or inflammatory disorders as defined in the protocol.
- •- Uncontrolled intercurrent illness as defined in the protocol.
- •- History of another primary malignancy except for (1) Malignancy
- •treated with curative intent and with no known active disease <= 5 years before the first dose of durvalumab and of low potential risk for
- •recurrence (2) Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease (3) Adequately treated carcinoma insitu without evidence of disease.
- •- History of leptomeningeal carcinomatosis
- •- History of active primary immunodeficiency
- •- Active infection including tuberculosis, hepatitis B, hepatitis C, or
- •human immunodeficiency virus (HIV; positive HIV 1/2 antibodies).
- •- Any unresolved toxicity NCI CTCAE Grade > = 2 from previous anticancer therapy with the exception of alopecia, vitiligo, lymphopenia, and the
- •laboratory values defined in the inclusion criteria
- •-Patients with Grade > = 2 neuropathy will be evaluated on a case-by-casebasis 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.
- •- Known allergy or hypersensitivity to any of the study drugs or any of
- •the study drug excipients
- •Prior/concomitant therapy
- •- Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab.
- •- Major surgical procedure (as defined by the Investigator) within 28
- •days prior to the first dose of durvalumab.
- •- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. Please refer to protocol for
- •exceptions.
- •- Participation in another clinical study with an IP administered in the last 4 weeks.
- •- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- •- Prior randomization or treatment in a previous durvalumab clinical
- •study regardless of treatment arm assignment
研究者
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