Osimertinib Combined With Bevacizumab in Patients With Brain Metastasis Epidermal Growth Factor Receptor (EGFR) Mutation Positive Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
There is no positive data on osimertinib in the treatment of metastatic EGFR mutation positive non-small-cell lung cancer (NSCLC). The purpose of this study is to study osimertinib combined with bevacizumab in the management of patients with brain metastasis harboring EGFR mutation.
详细描述
Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer (almost 20 percent [%] of cancer deaths); NSCLC accounts for 80% to 85% of lung cancers. The hypothesis is that osimertinib combined bevacizumab in patients with advanced NSCLC patients with brain metastasis characterized by EGFR mutations . Efficacy assessments will include disease assessment, symptomatic progression and patient-reported outcome. Safety assessments will include physical examinations, vital signs, electrocardiograms (ECGs), Eastern Cooperative Oncology Group (ECOG) performance status and clinical safety laboratory assessments (serum chemistry, hematology, coagulation, and urinalysis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must have histologically or cytologically confirmed, metastatic, nonsquamous non-small cell lung cancer (NSCLC) Partipiant harboring primary epidermal growth factor receptor (EGFR) Exon 18-21 mutation and brain metastasis.
- •Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.
- •Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, or
- •Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream.
- •A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.
排除标准
- •Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation.
- •Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis.
- •Participant has a contraindication to the use Osimertinib or Bevacizumab.
研究组 & 干预措施
study drug
osimertinib 80 mg, oral daily and bevacizumab 15mg/KG body weight intravenously infusion every 21 days
干预措施: osimertinib oral and bevazizumab intravenously (Drug)
结局指标
主要结局
PFS
时间窗: 30 months
Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review (BICR)
次要结局
- OS(Up to 48 months)
- ORR(Up to 48 months)