The CNS AE of Lorlatinib in Patients with ALK-positive Advanced NSCLC
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Incidence of central nervous system (CNS) adverse events (AEs) associated with lorlatinib in real world study.
研究概览
简要总结
The goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of Lorlatinib in patients with ALK-positive advanced non-small cell lung cancer.
详细描述
The goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of Lorlatinib in patients with ALK-positive advanced non-small cell lung cancer.
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
- •Patients with locally advanced (stage IIIb/IIIc), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not eligible for curative surgery and cannot undergo definitive radiotherapy/chemotherapy, according to the 8th edition of the TNM staging classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;
- •ALK-positive and the test results were based on RT-PCR /FISH /IHC /NGS methods in the laboratory department or testing institution of the hospital
- •receiving targeted therapy with Lorlatinib
- •age ≥18 years old
- •follow-up after receipt of Lorlatinib
- •voluntarily participate in the study and sign informed consent
排除标准
- •evidence of any severe or uncontrolled systemic illness, including uncontrolled hypertension and active bleeding, active infections including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
- •combined with other malignant tumors and received other anti-tumor therapy during the treatment of Lorlatinib
结局指标
主要结局
Incidence of central nervous system (CNS) adverse events (AEs) associated with lorlatinib in real world study.
时间窗: 2 year
The incidence of central nervous system (CNS) adverse events (AEs) associated with lorlatinib will be reported, such as cognitive effects, mood effects, speech effects and psychotic effects.
次要结局
- To explore the optimized therapy management strategies for CNS AEs associated with lorlatinib in real-world study.(1 year)
- Analysis of factors associated with developing CNS AEs related to lorlatinib treatment.(1 year)
- Correlation analysis between CNS AEs occurrence and anti-tumor efficacy(24 weeks)
研究者
Chunxia Su
Director of Clinical Research Center, Shanghai Pulmonary Hospital
Shanghai Pulmonary Hospital, Shanghai, China