Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The purpose of this study is to assess the Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.
详细描述
The purpose of this study is to assess the Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.
Our study was set up with several group with EGFR mutant, ALK fusion, ROS1 fusion, RET fusion, BRAF mutation, NRG1 fusion, MET alteration, KRAS mutation, etc.
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, Stage IV NSCLC.
- •Oncogenic mutations confirmed by an accredited local laboratory, including EGFR, ALK, ROS1 etc.
- •Predicted survival ≥ 12 weeks.
- •Adequate bone marrow hematopoiesis and organ function
- •Presence of measurable lesions according to RECIST 1.1.
排除标准
- •The patient did not match from the Inclusion Criteria.
研究组 & 干预措施
Cohort A: EGFR mutation
Lung Cancer with EGFR mutation including EGFR exon19del, exon 21L858R, etc.
干预措施: Osimertinib (Drug)
Cohort B: ALK fusion
Lung Cancer with ALK fusion.
干预措施: Alectinib 150 MG (Drug)
Cohort C: ROS1 fusion
Lung Cancer with ROS1 fusion.
干预措施: Crizotinib 250 MG (Drug)
Cohort D: MET alterations
Lung Cancer with MET alteration including amplification, exon 14 skipping and met fusion etc.
干预措施: Savolitinib, Crizotinib. (Drug)
Cohort E: RET fusion
Lung Cancer with RET fusion.
干预措施: Chemotherapy (Drug)
Cohort F: KRAS mutation
Lung Cancer with KRAS mutation.
干预措施: Chemotherapy (Drug)
Cohort G: uncommon mutation
Cohort G mainly includes all identified lung cancer mutations except EGFR mut, ALK fusion, ROS1 fusion, MET alterations, KRAS mut and RET fusion. These include: BRAF V600E and non-V600E, NRG fusion, NTRK fusion, ERBB2 amp and mut，NRAS mut, MAP2K1 mut，RIT1 mut, RAF1 mut, FGFR fusion, ARAF mut, HRAS mut etc.
干预措施: Chemotherapy (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 with target 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)(To assess overall survival, define as first dose to the death of the subject due to any cause up to 5 years)
- Adverse events (AEs) according to CTCAE 5.0(From first dose until 28 days after the last dose, up to 24 month)
- Objective Response Rate (ORR)(Time from first subject dose to study completion, or up to 36 month)
- Patient reported outcome (PRO)(To assess overall survival, define as first dose to the death of the subject due to any cause up to 5 years)
研究者
Yongchang Zhang
Professor, Director of Clinical Trial Center
Hunan Province Tumor Hospital