2024-511317-38-00招募中2 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 (CUBIK)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 33
- 试验地点
- 14
- 主要终点
- Overall response rate
研究概览
简要总结
To evaluate the Overall response rate (ORR) of brigatinib as measured by investigator. Overall response will be assessed per RECIST V1.1 criteria
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged equal or greater ≥18 years old
- •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
- •Adequate hematologic and organ function
- •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.
- •Willingness and ability to comply with scheduled visits and study procedures
- •For female patients of childbearing potential, a negative pregnancy test must have been documented prior to enrollment (within 14 days prior to enrollment)
- •ECOG performance status of 0-2
- •Histologically or cytologically confirmed, Stage IIIB or IV NSCLC
- •Patients who have documented locally ALK rearrangement
- •No prior treatment for Stage IIIB or IV non-squamous NSCLC.
- •Having a life expectancy ≥ 3 months
- •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.
- •Untreated or treated CNS metastases allowed, as long as asymptomatic and neurologically stable
- •Patients with at least 1 measurable lesion, as defined by RECIST v1.1
排除标准
- •Patients with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene, STK-1 Ligand alteration, MDM2 amplification or ROS1 translocations.
- •Have uncontrolled hypertension
- •Positive test for HIV. A and patients with active hepatitis B or active tuberculosis
- •Severe infections within 2 weeks prior to be included in the study
- •Have significant, uncontrolled or active cardiovascular disease
- •Patients with illnesses or conditions that interfere with their capacity to understand follow and/or comply with study procedures
- •Patients that received any prior TKI, including ALK-targeted TKIs or any systemic anticancer therapy for locally advanced or metastasic disease
- •Patients that have received chemotherapy or radiation within 14 days of first dose of study drug.
- •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
- •Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression is allowed.
- •Malignancies other than NSCLC within 3 years prior to enrollment
- •Women who are pregnant, lactating, or intending to become pregnant during the study
- •Patients that received monoclonal antibodies or had major surgery within 30 days of the first dose of brigatinib
- •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.
结局指标
主要结局
Overall response rate
Overall response rate
次要结局
- Duration of response (DOR)
- Intracranial overall response rate
- PFS rate at 1 year and 2 years
- Overall Survival (OS) rate at 1 year and 2 years
- Safety and tolerability of brigatinib
研究者
Mariano Provencio
Scientific
Fundacion GECP
研究点 (14)
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