跳至主要内容
临床试验/NCT05965557
NCT05965557招募中不适用

A Biomarker Study for Predicting the Response of Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer Based on Circulating Tumor DNA and Homologous Recombination Deficiency Analysis

Geneplus-Beijing Co. Ltd.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Correlation between HRD and MPR rate/2 years DFS

研究概览

简要总结

Neoadjuvant immunotherapy has become the standard perioperative treatment in lung cancer, but its effective predictive biomarkers are lacking. A small cohort reported that homologous recombination deficiency (HRD) can be used as a reliable biomarker to predict the efficacy of neoadjuvant immunotherapy, but the findings need to be validated in larger cohorts. Moreover, circulating tumor DNA (ctDNA) has the potential to predict the therapeutic efficacy of neoadjuvant immunotherapy.

This study intends to prospectively collect patients with driver-negative stage II-IIIB NSCLC who are scheduled to receive neoadjuvant immunotherapy and surgical resection and verify the value of HRD in predicting the efficacy of neoadjuvant immunotherapy. Meanwhile, the blood samples before and after neoadjuvant immunotherapy were collected for high-depth ctDNA detection to explore the correlation between the dynamic changes of ctDNA and the efficacy and prognosis of neoadjuvant immunotherapy.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stage II-IIIB NSCLC
  • EGFR/ALK negative
  • The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up

排除标准

  • A history of other malignancies within the past 5 years
  • Patients with autoimmune disease are not suitable for PD1 monoclonal antibody therapy

结局指标

主要结局

Correlation between HRD and MPR rate/2 years DFS

时间窗: 2023/12-2025/12

Correlation between homologous recombination deficiency (HRD) events and major pathological response (MPR) rate and DFS of 2 years

次要结局

未报告次要终点

研究者

发起方
Geneplus-Beijing Co. Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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