Drug Concentration Monitoring of Pembrolizumab in Treatment-naive Non-Small Cell Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Objective response
研究概览
简要总结
This observational study explores associations between drug trough-levels and clinical outcomes in Non Small Cell Lung Cancer (NSCLC) patients treated with immunotherapy (pembrolizumab) either alone or combined with chemotherapy. Through-levels of pembrolizumab will be examined in blood samples collected during the first-line treatment period. In addition T-cell responses in peripheral blood and anti-drug antibodies will be monitored. Results of drug trough-levels and T-cell responses will be linked to clinical outcome. 250 patients with NSCLC will be enrolled in this trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be > 18 years and must voluntary sign an informed consent
- •Treatment-naïve patients with advanced NSCLC receiving immunotherapy alone (pembrolizumab) or combined with chemotherapy
排除标准
- •Any anti-cancer therapy < 6 months prior to study start
- •Radio- or chemotherapy against lung cancer <2 years before study start
- •Previous treatment with immunotherapy
- •Patients with mutations with specific treatment (i.e. EGFR, ALK, Ros1)
研究组 & 干预措施
Treatment-naive NSCLC patients
Treatment-naive NSCLC patients receiving immunotherapy (pembrolizumab) alone or in combination With chemotherapy divided in groups based on treatment administered. Clinical information will be gathered at start of treatment and at evaluations every 3rd month.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Objective response
时间窗: 3 months
Radiological response (Partial response/stable disease/Complete response)
次要结局
- Overall survival(5 years observation)
- Adverse events(2 years)
- PD-1 Expression on CD-8 T-cells(First 3 months)
- Progression-Free survival(1 year)
研究者
Ragnhild Nome
Principal Investigator
Oslo University Hospital