Clinical Study of Personalized Neoantigen Peptide Vaccine Combined With Targeted Drugs in the Treatment of Non-small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adverse events evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
研究概览
简要总结
Neoantigen vaccine is a new field of research in tumor immunotherapy, and some studies have been conducted with success on Melanoma and glioblastoma. Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV) and EGFR mutant non-small cell lung cancer will be resistant after targeted drug treatment. Neoantigen vaccine is a new treatment method for lung cancer, especially for patients with drug resistance.
详细描述
This is a phase I clinical study of individualized neoantigen peptide vaccine combined with targeted drugs in the treatment of EGFR mutant non-small cell lung cancer aimed to evaluated the safety and immune response of the neoantigen vaccine treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Histologically confirmed locally advanced or metastatic non-small-cell lung cancer (stage III or stage IV).
- •With EGFR-TKI sensitive mutations and no T790M.
- •First generation EGFR-TKI treatment is in progress, the treatment time is 5-6 months and there is no disease progression.
- •Patients aged 18 to 85
- •Life expectancy of at least 3 months.
- •ECOG Performance Status 0 to
- •No previous immunotherapy, including anti-PD-1/PD-L1 or co-suppressive T cell receptor drug therapy, peptide / mRNA neoantigen immunotherapy and cell therapy.
- •Ability to follow research and follow-up procedures. Able to understand and willing to sign an IRB approved written informed consent document.
排除标准
- •Pregnant and/or breastfeeding.
- •With active, known or suspected autoimmune diseases or other concurrent immune system diseases.
- •Receive systemic cytotoxic chemotherapy or experimental drugs within 4 weeks before the start of neoantigen treatment, excluding EGFR-TKI and anti-angiogenesis targeted drugs.
- •Patients participated in other anticancer drug clinical trials within 4 weeks.
- •Liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and impaired hematopoietic function.
- •Systemic infection.
- •Any uncertainties that have an impact on the safety or compliance of the patient.
- •Any disease, treatment, abnormal laboratory history or medical history that affects the participant's participation in the entire research process, or the investigator believes that it is not suitable to participate in this study.
研究组 & 干预措施
neoantigen vaccine + EGFR-TKI
干预措施: neoantigen vaccine + EGFR-TKI (Drug)
neoantigen vaccine + anti-angioge
干预措施: neoantigen vaccine + anti-angioge (Drug)
结局指标
主要结局
Adverse events evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
时间窗: 24 months
Safety
次要结局
- Progression-free Survival (PFS)(Up to 2 years)
- Overall survival (OS)(Up to 2 years)
- Disease Control Rate(DCR)(Up to 12 weeks)
研究者
YAN ZHANG
Director of Oncology IV
First Hospital of Shijiazhuang City