EUCTR2019-002537-11-LT进行中（未招募）1 期
Durvalumab (MEDI4736) After chemoRadioTherapy (DART) for NSCLC patients – a phase II translational and biomarker study investigating PDL1 positive and negative patients - DART (19-14434)
Oslo University Hospital0 个研究点目标入组 100 人开始时间: 2020年2月13日最近更新:
适应症
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
- 100
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
- •For inclusion in the study patients must fulfill all of the following criteria:
- •1.Locally-advanced, unresectable, stage 3 NSCLC (including PET-CT
- •and MRI-brain in the diagnostic work-up).
- •2.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 and
- •any locally required authorization (European Union [EU] Data Privacy
- •Directive in the EU) obtained from the patient/legal representative prior
- •to performing any protocol-related procedures, including screening evaluations.
- •3.Diagnostic biopsy with PDL1 <1% in 50 patients PDL1 =1% in 50
- •4.Adequate core or excisional biopsy
- •5.Age = 18 years at time of study entry
- •6.Eastern Cooperative Oncology Group (ECOG performance status of 0,
- •7.Life expectancy of at least 12 weeks
- •8.Body weight >30 kg
- •9.Adequate normal organ and marrow function as defined below:
- •Hemoglobin =9.0 g/dL
- •Absolute neutrophil count (ANC) 1.5 (or 1.0) x (> 1500 per mm3)
- •Platelet count =100 (or 75) x 109/L (>75,000 per mm3)
- •Serum bilirubin =1.5 x institutional upper limit of normal (ULN).
- •AST (SGOT)/ALT (SGPT) =2.5 x institutional upper limit of normal
- •unless liver metastases are present, in which case it must be =5x ULN
- •Measured creatinine clearance (CL) >40 mL/min or Calculated
- •creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and
- •Gault 1976) or by 24-hour urine collection for determination of
- •creatinine clearance
- •10.Evidence of post-menopausal status or negative urinary or serum
- •pregnancy test for female pre-menopausal patients. Women will be
- •considered post-menopausal if they have been amenorrheic for 12
- •months without an alternative medical cause.
- •11.Women of childbearing potential should have a negative urine or
- •serum pregnancy test within 7 days prior to receiccing first dose of study
- •medication. if the urine test is positive or cannot be confirmed as
- •negative, a serum pregnancy test will be required. A woman is
- •considered WOCBP, i.e. fertile, following menarche and untill becoming
- •post-menopausal unkess permanently sterile. Permanent sterilisation
- •methods include hysterectomy, bilateral salpingectomy and bilateral
- •oophorectomy.
- •12. WOCBP should use an adequate method to avoid pregnancy
- •13.Males who are sexually active with women of childbearing potential
- •must agree to follow instructions for method(s) of contraception for a
- •period of 90 days (duration of sperm turnover) plus the time required for
- •the investigational drug to undergo five half-lives
- •14.Patient 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 50
- 另有 2 项未显示
排除标准
- •1.Non-small cell lung cancer disease suitable for curative surgery
- •2.Significant cardiac, pulmonary or other medical illness that would
- •limit activity or survival
- •3.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 during the last 2 weeks.
- •4.Any concurrent chemotherapy, Investigational product (IP), biologicor homonal therapy for cancer treatment. Concurrent use of hormonal
- •therapy for non-cancer related conditions (e.g. hormone replacement
- •therapy) is acceptable.
- •5. Major surgical procedure (as defined by the Investigator) within 28
- •days prior to the first dose of IP. Note: Local surgery of isolated lesions
- •for palliative intent is acceptable.
- •6. History of allogenic organ transplantation.
- •7.Active or prior documented autoimmune or inflammatory disorders
- •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 5 years may be included
- •but only after consultation with the study physician
- •e.Patients with celiac disease controlled by diet alone
- •8.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
- •9.History of another primary malignancy except for
- •a.Malignancy treated with curative intent and with no known active
- •disease =5 years before the first dose of IP and of low potential risk for
- •b.Adequately treated non-melanoma skin cancer or lentigo maligna
- •without evidence of disease
- •c.Adequately treated carcinoma in situ without evidence of disease
- •10.History of active primary immunodeficiency or medical condition
- •requiring high doses (>30 mg prednisolone daily) of systemic steroids or
- •other forms of immunosuppressive therapy
- •11.Active infection including tuberculosis (clinical evaluation that
- •includes clinical history, physical examination and radiographic findings,
- •and TB testing in line with local practice), hepatitis B (known positive
- •HBV surface antigen (HBsAg) result), and hepatitis C. Patients with a
- •past or resolved HBV infection (defined as the presence of hepatitis B
- •core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients
- •positive for hepatitis C (HCV) antibody are eligible only if polymerase
- •chain reaction is negative for HCV RNA.
- •12.Current or prior use of immunosuppressive medication within 14
- •days before the first dose of durvalumab. The following are exceptions to
- •this criterion:
- 另有 8 项未显示
研究者
相似试验
进行中（未招募）
1 期
Durvalumab (MEDI4736) After chemoRadioTherapy (DART) for NSCLC patients – a phase II translational and biomarker study investigating PDL1 positive and negative patientsEUCTR2019-002537-11-FIOslo University Hospital100
招募中
2 期
DART (19-14434)
Durvalumab (MEDI4736) After chemoRadioTherapy (DART) for NSCLC patients – a phase II translational and biomarker study investigating PDL1 positive and negative patients2022-502640-12-01Oslo University Hospital Hf130
已完成
不适用
Durvalumab after chemoradiotherapy in non-small cell lung cancer harboring driver gene mutation/translocation: a retrospective multicenter study (HOT2101)non-small cell lung cancerJPRN-UMIN000048100Hokkaido Lung Cancer Clinical Study Group(HOT)88
已完成
2 期
Radiochemotherapy +/- Durvalumab for locally-advanced Anal Carcinoma. A multicenter, randomized, phase II trial of the German Anal Cancer Study GroupC21Malignant neoplasm of anus and anal canalDRKS00020739Goethe Universität; Universitätsklinikum Frankfurt Goethe-Universität180
招募中
1 期
Radiochemotherapy +/- Durvalumab for locally-advanced Anal CarcinomaA multicenter, randomized, phase II trial of the German Anal Cancer Study Groupanal cancer (UICC-Stage IIB-IIIC, incl. T2>4cm Nany )MedDRA version: 21.1Level: PTClassification code 10002136Term: Anal cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10002137Term: Anal cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-003005-25-ATniversity Hospital Frankfurt, Goethe University178