EUCTR2019-004336-31-FR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 Non-Small Cell Lung Cancer Who Are Ineligible for Chemotherapy (DUART) - DUART
适应症
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 to first 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 in situ 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-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.
- •- 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
- •Please refer to the protocol pages 38-39 for further criteria.
研究者
相似试验
进行中（未招募）
1 期
This is a phase II, open-label, multi-centre study to determine the safety and tolerability of durvalumab in patients with non-small cell lung cancer who were treated with radiation therapy but are ineligible for chemotherapyPatients with Stage III unresectable Non-small cell lung cancer (NSCLC),who have an Eastern Cooperative Oncology Group (ECOG) PS of 0 to 2 and who are treated with radiotherapy but are ineligible for chemotherapyMedDRA version: 21.1Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-004336-31-ITASTRAZENECA AB150
进行中（未招募）
1 期
This is a phase II, open-label, multi-centre study to determine the safety and tolerability of durvalumab in patients with non-small cell lung cancer who were treated with radiation therapy but are ineligible for chemotherapyPatients with Stage III unresectable Non-small cell lung cancer (NSCLC), who have an Eastern Cooperative Oncology Group (ECOG) PS of 0 to 2 and who are treated with radiotherapy but are ineligible for chemotherapyMedDRA version: 21.1Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-004336-31-PLAstraZeneca AB150
进行中（未招募）
1 期
Study comparing palbociclib and fulvestrant versus capecitabine in patients with advanced breast cancerAdvanced breast cancer.MedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864EUCTR2016-002893-11-GBKarolinska University Hospital196
进行中（未招募）
1 期
Study comparing palbociclib and fulvestrant versus capecitabine in patients with advanced breast cancerEUCTR2016-002893-11-SEKarolinska University Hospital196
进行中（未招募）
1 期
This is a Phase II, open-label, multi-centre study to determine the safety of a fixed dose of durvalumab in patients with Non-Small Cell Lung Cancer who have not progressed after sequential chemoradiation therapy.Patients with unresectable Stage III non-small cell lung cancer (NSCLC), who have not progressed following platinum-based sequential chemoradiation therapy (sCRT)MedDRA version: 20.0Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-002220-16-ESAstraZeneca AB150