Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors With or Without Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12,000
- 试验地点
- 1
- 主要终点
- Correlation between Adverse events (AEs) and gene profile
研究概览
简要总结
The purpose of the study is to find some biomarkers to predict the the adverse events of Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy in lung cancer.
详细描述
The purpose of the study is to find some biomarkers to predict the the adverse events of Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy in lung cancer.
Step 1: All the lung cancer patients treated with Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy were enrolled in this study.
Step 2: All the adverse events were evaluated by principal investigator. Step 3: All the blood and FFPE samples were collected for further anaysis. Step 4: Correlation between adverse events and gene profile was analysis. Step 4: Predict model was construted with AI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
- •Age ≥ 18 years.
- •Histologically or cytologically confirmed lung cancer.
- •Treated with Immune Checkpoint Inhibitors with or without chemotherapy.
- •Predicted survival ≥ 12 weeks.
- •Adequate bone marrow hematopoiesis and organ function
- •Presence of measurable lesions according to RECIST 1.1.
排除标准
- •Any conditions can not match for the Inclusion Criteria, includign do not have the data to perform Adverse Events evalutation.
研究组 & 干预措施
Cohort A: Chemotherapy plus Immune Checkpoint Inhibitors
Lung Cancer patients treated with Chemotherapy plus Immune Checkpoint Inhibitors.
干预措施: Pemetrexed plus Pembrolizumab (Drug)
Cohort B: Immune Checkpoint Inhibitors monotherapy
Lung Cancer patients treated with Immune Checkpoint Inhibitors monotherapy.
干预措施: Pembrolizumab (Drug)
Cohort C: Chemotherapy Group.
Lung Cancer patients treated with Chemotherapy.
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Correlation between Adverse events (AEs) and gene profile
时间窗: Time from first subject dose to study completion, or up to 36 month
Correlation between Adverse events (AEs) and gene profile
次要结局
- Correlation between Adverse events (AEs) and survival outcome(Time from first subject dose to study completion, or up to 36 month)
- Adverse events (AEs) rate according to CTCAE 5.0(Time from first subject dose to study completion, or up to 36 month)
研究者
Yongchang Zhang
Professor, Director of Clinical Trial Center
Hunan Province Tumor Hospital