NCT04945200Unknown不适用
Neoadjuvant Immune Checkpoint Inhibitor Combined With Chemotherapy in Non-small Cell Lung Cancer: Clinical Response and Biomarkers Analysis
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- molecular biomarkers related to clinical response
研究概览
简要总结
The primary object of this study is to determine tumor major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer who subjected to neoadjuvant immune checkpoint inhibitor combined with chemotherapy and molecular biomarkers related to the clinical response.
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
- 否
入选标准
- •1.Able to understand the nature of this trial and provide written informed consent.
- •2.18 years ≤ age ≤ 80 years
- •3.Histologically documented non-small cell lung cancer
- •4.NSCLC with resection option for potential cure.This may include clinical stage IB, II and IIIA.
- •5.Subjected to neoadjuvant immune checkpoint inhibitor combined with chemotherapy according to disease evaluation.
- •6.Measurable disease by RECIST v1.1
- •7.Tumor tissue sample and/or alveolar lavage fluid must be available for biomarker evaluation before operation.
排除标准
- •Subjects are excluded if they are enrolled in any other interventional studies.
- •Administration of chemotherapy, device therapy or any other cancer therapy in 4 weeks before the study drug administration.
- •Subjects are excluded if they have an active, known or suspected autoimmune disease requiring systemic treatment (e.g.corticosteroids or other immunosuppressive medications) in 2 years before the study drug administration. substitution therapy ( e.g. thyroxine, insulin) are permitted.
- •Subjects with active concurrent malignancies are excluded i.e. cancers other than NSCLC.
- •History of allergy to study drug components
- •Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results.
- •Any other conditions that, in the Investigator's opinion, unfit to attend this study.
结局指标
主要结局
molecular biomarkers related to clinical response
时间窗: change from baseline to postoperation, an average of 1 week
molecular biomarkers related to tumor major pathological response (MPR) and pathologic complete response (pCR) in stage IB-IIIA non-small cell lung cancer who subjected to neoadjuvant immune checkpoint inhibitor combined with chemotherapy
次要结局
未报告次要终点
研究者
研究点 (1)
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