Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Although several clinical trials provide evidence for efficacy benefit for Checkpoint Inhibitors plus chemotherapy for lung cancer. However, there was rare evidence for clinical evidence in Hunan province.
详细描述
This prospective study aimed to assess its efficacy and adverse event for Checkpoint Inhibitors with or without chemotherapy in clincial practice. Several cohorts were devided including pathological type, treatment line, treatment regiems, combination strategies. Tissue samples were collected with permission of patients for TME evaluation.
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
- •≥18，Lung Cancer Confirmed by Histopathology
- •Treated with Chemotherapy with or Without Checkpoint Inhibitors.
- •Predicted survival ≥ 12 weeks.
- •Adequate bone marrow hematopoiesis and organ function
- •Presence of measurable lesions according to RECIST 1.
- •Subjects with stable brain metastases may be included in the study.
排除标准
- •Patients did not match for the Inclusion Criteria.
研究组 & 干预措施
Cohort A
Extansive Stage Small Cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors .
干预措施: Immune checkpoint inhibitor (Drug)
Cohort B
Limit Stage Small Celll Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors .
干预措施: Immune checkpoint inhibitor (Drug)
Cohort C
Small Celll Lung Cancer who progressed from first line treatment and received subsequential Chemotherapy with or without Checkpoint Inhibitors.
干预措施: Immune checkpoint inhibitor (Drug)
Cohort D
Metastastic Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.
干预措施: Immune checkpoint inhibitor (Drug)
Cohort E
Metastastic Non-small cell Lung Cancer who progressed from first line treatment and received subsequential Chemotherapy with or without Checkpoint Inhibitors.
干预措施: Immune checkpoint inhibitor (Drug)
Cohort F
Resectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.
干预措施: Immune checkpoint inhibitor (Drug)
Cohort G
Unresectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.
干预措施: Immune checkpoint inhibitor (Drug)
Cohort H
Non-small cell Lung Cancer received neoadjuvent or adjuvent Chemotherapy with or without Checkpoint Inhibitors.
干预措施: Immune checkpoint inhibitor (Drug)
Cohort I
Cohort I, Non-small cell Lung Cancer with EGFR, ALK and ROS1 sensitive mutation who received Chemotherapy with or without Checkpoint Inhibitors.
干预措施: Immune checkpoint inhibitor (Drug)
Cohort J
Non-small cell Lung Cancer with other oncogenic mutation including RET, BRAF etc who received Chemotherapy with or without Checkpoint Inhibitors.
干预措施: Immune checkpoint inhibitor (Drug)
Cohort K
Non-small cell Lung Cancer received Chemotherapy plus bevacizumab with or without Checkpoint Inhibitors.
干预措施: Immune checkpoint inhibitor (Drug)
Cohort L
Non-small cell Lung Cancer who enrolled in clinical trials.
干预措施: Immune checkpoint inhibitor (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Time from first subject dose to study completion, or up to 36 month
To assess progression-free survival of patients treated by different treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause
次要结局
- Overall survival (OS)(Time from first subject dose to study completion, or up to 36 months.)
- Duration of Response (DOR)(Time from first subject dose to study completion, or up to 36 month)
- Patient reported outcome(Time from first subject dose to study completion, or up to 36 months.)
- Objective Response Rate (ORR)(Time from first subject dose to study completion, or up to 36 months.)
- Adverse events (AEs) according to CTCAE 5.0(From first dose until 28 days after the last dose, up to 24 month)
研究者
Yongchang Zhang
Professor, Director of Clinical Trial Center
Hunan Province Tumor Hospital