跳至主要内容
临床试验/NCT05701787
NCT05701787招募中不适用

Molecular Landscape Analysis and Clinical and Therapeutic Implications for NSCLC Patients With Rare Mutations

Shanghai Chest Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年1月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaomin Niu

Principal Investigator

Shanghai Chest Hospital

研究点 (1)

Loading locations...

相似试验

Molecular Landscape Analysis and Clinical... | 临床试验