EUCTR2019-002369-36-ES进行中（未招募）1 期
Clinical Utility of Liquid Biopsy as a tool to assess the evolution of brigatinib treated patients with non-small cell lung cancer with EML4-ALK translocation: an exploratory study - Clinical Utility of liquid biopsy in Brigatinib ALK+ patients_CUBIK
Fundación GECP0 个研究点目标入组 30 人开始时间: 2020年1月14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
- 30
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
- •1. Male or female, aged = 18 years old
- •2. ECOG performance status of 0-2
- •3. Histologically or cytologically confirmed, Stage IIIB or IV NSCLC
- •4. Patients who have documented locally ALK rearrangement
- •5. No prior treatment for Stage IIIB or IV non-squamous NSCLC.
- •6. Having a life expectancy = 3 months
- •7. Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemo-radiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from enrollment since the last chemotherapy, radiotherapy, or chemo-radiotherapy.
- •8. Untreated or treated CNS metastases allowed, as long as asymptomatic and neurologically stable
- •9. Patients with at least 1 measurable lesion, as defined by RECIST v1.1
- •10. Normal QT interval (QT) on screening ECG evaluation, defined as QT interval corrected (Fridericia) (QTcF) of = 450 milliseconds (msec) in males of = 470 msec in females
- •11. Adequate hematologic and organ function
- •12. All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention.
- •13. Willingness and ability to comply with scheduled visits and study procedures
- •14. For female patients of childbearing potential, a negative pregnancy test must have been documented prior to enrollment (within 14 days prior to enrollment)
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Patients with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene, STK-1 Ligand alteration, MDM2 amplification or ROS1 translocations.
- •2. Patients that received any prior TKI, including ALK-targeted TKIs or any systemic anticancer therapy for locally advanced or metastasic disease
- •3. Patients that have received chemotherapy or radiation within 14 days of first dose of study drug.
- •4. Symptomatic CNS metastases (parenchymal or leptomeningeal) that are neurologically unstable or required an increasing dose of corticosteroids within 7 days prior to first dose of study drug
- •5. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression is allowed.
- •6. Malignancies other than NSCLC within 3 years prior to enrollment
- •7. Women who are pregnant, lactating, or intending to become pregnant during the study.
- •8. Patients that received monoclonal antibodies or had major surgery within 30 days of the first dose of brigatinib
- •9. History of idiopathic pulmonary fibrosis, pulmonary interstitial disease, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- •10. Have uncontrolled hypertension
- •11. Positive test for HIV. A and patients with active hepatitis B or active tuberculosis
- •12. Severe infections within 2 weeks prior to be included in the study
- •13. Have significant, uncontrolled or active cardiovascular disease
- •14. Patients with illnesses or conditions that interfere with their capacity to understand follow and/or comply with study procedures
研究者
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