Phase II Study of Peptide Cancer Vaccine S-488410 to Treat Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Evaluation of difference in overall survival after vaccination therapy between HLA-A 24:02 and non-HLA-A 24:02 patients.
研究概览
简要总结
The investigators identified three cancer-testis antigens, as targets for cancer vaccination against lung cancer. In this clinical study, the investigators examine using a combination of three peptides from these three antigens (S-488410) the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced non-small cell lung cancer patients.
详细描述
The purpose of this study is to evaluate the clinical efficacy and safety of S-488410 for advanced non-small cell lung cancers who failed to standard therapy.
The investigators previously identified three novel HLA-A*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, as targets for cancer vaccination against lung cancer. In this phase II trial, we examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A*2402-positive advanced small cell lung cancer patients who failed to standard therapy.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced NSCLC that cannot undergo curative surgery.
- •Patients that are refractory to standard chemotherapy or cannot be treated with further therapy due to severe adverse effects of chemotherapy.
- •Histologically diagnosed NSCLC.
- •Clinical efficacy can be evaluated by radiologic methods within 4 weeks prior to receiving treatment.
- •ECOG performance status 0-2 within 2 weeks prior to receiving treatment.
- •Life expectancy > 3 months.
- •Age between 20 to 79
- •Male or Female.
- •In patients or out patients.
- •Able and willing to give valid written informed consent.
排除标准
- •Other malignancy requiring treatment
- •radiation, immunotherapy, hyperthermia, or surgery.
- •Active and uncontrolled infectious disease
- •Active and uncontrolled hepatic dysfunction, kidney dysfunction, cardiac disease, or lung disease (i.e. interstitial pneumonia).
- •Autoimmune disease.
- •HIV-Ab or antigen positive
- •Prior anti-cancer therapy within 4 weeks
- •Laboratory values as follows: 2000<mm3 < WBC < 15000/mm3, Platelet count < 50000/mm3, Asparate transaminase > 5 X cutoff value, Alanine transaminase > 5 X cutoff value, Total bilirubin > 3 X cutoff value, and Serum creatinine > 3X cutoff value.
- •Patients knows HLA-A type.
- •Breastfeeding and Pregnancy (woman of child bearing potential)
- •Refusal of pregnancy conception.
- •Treated with S-488401, S-488402, or S-
- •Treated with other investigational drug within 3 months prior to receiving S-48810 treatment.
- •Decision of nonenrollment of the patients by principal investigator or physician-in-charge from the view point of patient's safety.
研究组 & 干预措施
S-488410
干预措施: S-488410 (Drug)
结局指标
主要结局
Evaluation of difference in overall survival after vaccination therapy between HLA-A 24:02 and non-HLA-A 24:02 patients.
时间窗: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
次要结局
- CTL response between HLA-A24:02 and non-HLA-A24:02(Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.)
- PFS and ORR between HLA-A24:02 and non-HLA-A24:02(Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.)
- PFS and OS between CTL response positive and negative(Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.)
- Safety and tolerability: Number of Adverse Events with information of disease, grade and incidence(Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.)
- Identification of biomarkers for efficacy and safety that are mentioned above(Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.)
研究者
Yataro Daigo
Professor of Medical Oncology, Director of Cancer Center
Shiga University