A Phase I/Phase II Study of Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The toxicity of combinate nintedanib and EGFR TKI
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Nintedanib with EGFR-TKI in participants with advanced EGFR-TKI-resistant non-small cell lung cancer
详细描述
The efficacy of the regimen is evaluated by participants' progression-free survival and overall survival.
Nintedanib is a medication that blocks endothelial cells in tumor microenvironments and is effective in delaying tumor progression. Nintedanib is also a drug approved for idiopathic pulmonary fibrosis in the clinic.
The participants will take 1 nintedanib tablet after a meal twice per day with a twelve-hour interval. EGFR TKI-gefitinib, erlotinib, afatinib, or osimertinib will be taken 1 tablet once per day during each treatment cycle. The treatment cycle in this study is 30 days.
In this study, the participants will have a physical exam in 6 weeks and 12 weeks after the initiation of the treatment. In the 6 weeks of the study, the participants will have blood tests and a CT scan. About 5cc of blood will be collected each time. In addition, the participant's tumor will be measured by a CT scan every 12 weeks.
If the participants develop any unacceptable symptoms or changes in liver function tests, the participants' treatment may be delayed and/or the dose decreased until the symptoms are disappeared. It may even be necessary to stop your treatment. The doctor will inform the participant of any changes in the participants' treatment schedule or in the doses of medication after he/she evaluates the participants in the clinic.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants between 20 to 70 years old, are pathologically confirmed advanced (stage III and IV) non-small cell lung cancer.
- •Positive EGFR mutations are diagenesis.
- •Participants with histologically/cytologically confirmed locally advanced or metastatic adenocarcinoma subtype NSCLC after the failure of first-line EGFR tyrosine kinase inhibitors- gefitinib, erlotinib, afatinib, or osimertinib.
- •Participants must have adequate hepatic, renal, and bone marrow function
排除标准
- •Participants previously received first-line EGFR tyrosine kinase inhibitor with serious side effects.
- •Participants have known hypertension, and chronic liver and gastrointestinal disease.
- •Participants have known brain metastasis.
- •Female participants who are pregnant or breast-feeding
- •Participants have a known diagnosis of negative nPKCδ expression by immunohistochemistry (IHC).
研究组 & 干预措施
Nintedanib + gefitinib/erlotinib/afatinib/osimertinib
Nintedanib will administered orally twice per day Gefitinib will administered orally once daily Erlotinib will administered orally once daily Afatinib will administered orally once daily Osimertinib will administered orally once daily
干预措施: Nintedanib, gefitinib, erlotinib, afatinib, osimertinib (Drug)
结局指标
主要结局
The toxicity of combinate nintedanib and EGFR TKI
时间窗: Assessed every 6 weeks of chest CT scan until PD.
Patient objective response rate
时间窗: Assessed every 6 weeks of chest CT scan
次要结局
- Overall survival(Assessed every 12 weeks thereafter up to end of study at approximately 2 years)