Phase II Study of Afatinib Plus Bevacizumab in the Treatment Epidermal Growth Factor Receptor (EGFR) Exon G719X, S768I, and L861Q Mutation Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
There is no report afatinib plus bevacizumab in the treatment of EGFR G719X, S768I, and L861Q single or compond mutation of metastatic non-small-cell lung cancer (NSCLC). The purpose of this study is to study afatinib combined with bevacizumab in the management of it.
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 afatinib plus bevacizumab in patients with metastatic NSCLC characterized by EGFRuncommon mutations with G719X, S768I, and L861Q. 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 85 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, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon G719X, S768I, L861Q mutation 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 2 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 afatinib or Bevacizumab
研究组 & 干预措施
afatinib plus bevacizumab
afatinib 40mg oral continually bevacizumab 15mg/kg, iv day 1, every 21days until disease progression, untolerated toxicities of patient death.
干预措施: afatinib (Drug)
结局指标
主要结局
progression-free survival
时间窗: up to 18 months
Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review (BICR)
次要结局
- overall survival(Up to 48 months ])
- Objective Response Rate (ORR)(up to 18 months)