Molecular Landscape Analysis and Clinical and Therapeutic Implications for NSCLC Patients With Rare Mutations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Lung cancer is the most common primary cancer of the lung and is responsible for the ever increasing number of cancer-related deaths worldwide. Especially in China, the burden of lung cancer has been rising rapidly due to its large and growing population. Histologically, approximately 85% of lung cancers are non-small-cell lung cancer (NSCLC).
Molecular targeted therapy has been shown to dramatically improve the quality of life and survival outcomes of NSCLC patients. One of the most important targeted drugs in NSCLC has been the epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs), while there exists some other rare targetable mutation in NSCLC. Emerging evidence underlines that, rather than a single point mutation, some rare mutations present with a wide array of mutations, essentially in NSCLC.
Different rare mutations with NSCLC have divergent clinical and therapeutic implications with a particular distinction. Therefore, there is an unmet need for more effective therapies for NSCLC with rare mutations. In summary, identification of genetic alterations in NSCLC with rare mutations is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with NSCLC with rare mutations to further the characterization of molecular alterations and develop (novel) treatments based on the detection.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Histologically proven diagnosis of NSCLC with rare mutations including EGFR rare mutations, ALK fusion, ROS1 fusion, BRAF V600E, cMET exon 14 skipping, KRAS G12C, RET fusion, NTRK fusion, etc.
- •18 years of age or older
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- 未提供
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 20 years
Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records
Objective response rate (ORR)
时间窗: 20 years
Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records
Disease control rate (DCR)
时间窗: 20 years
Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records
次要结局
- Overall survival (OS)(20 years)
研究者
Xiaomin Niu
Principal Investigator
Shanghai Chest Hospital
