Effect of Platinum-based Chemotherapy on Tumor Mutation Burden in Patients With Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tumor Mutation Burden Change
研究概览
简要总结
Tumor mutation burden is identified as an important biomarkers for predicting PD-1/PD-L1 inhibitors in advanced Non-Small Cell Lung Cancer. Several previous clinical trials have demonstrated that chemotherapy could enhance the efficacy of PD-1/L1 immunotherapy in NSCLC such as Checkmate-227, Impower-150, Keynote-189, etc. Pre-clincial experiment shows that chemotherapy could increase CD8 TIL infiltration in tumor microenvironment, activate T cell immune reaction. However, it remains unclear whether chemotherapy could affect tumor mutation burden in advanced NSCLC patients. The present study aims to evaluate whether tumor mutation burden will change after receiving chemotherapy in advanced NSCLC patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced NSCLC diagnosed histologically; Expected survival ≥ 6 month;
- •Without Druggable molecular events (EGFR, ALK, c-Met, BRAF, Ret, etc)
- •ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min
排除标准
- •Patient can not comply with research program requirements or follow-up;
- •Patient will receive immunotherapy;
结局指标
主要结局
Tumor Mutation Burden Change
时间窗: every 6 weeks up to progression disease
Tumor mutation burden will be calculated using a 520 genes NGS panel
次要结局
未报告次要终点
研究者
Baodong Qin
Principal Investigator
Shanghai Changzheng Hospital