An Observational Study of Patients With Newly Diagnosed Unresectable Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC) in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,378
- 试验地点
- 11
- 主要终点
- Demographic and Socio-Behavioral Characteristics
研究概览
简要总结
The purpose of this observational study is to describe patient and disease characteristics as well as treatment patterns in Chinese patients with unresectable stage IIIB or IV non-small cell lung cancer (NSCLC). In addition, this study characterizes the clinical outcomes for various populations of patients defined by clinical and tumor characteristics, treatment patterns, and hospital category defined by city tier and geographic region.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically/cytologically confirmed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
- •Received at least one anti-cancer treatment targeting unresectable Stage IIIB or IV NSCLC in the study site after study initiation
- •Radiographic evidence of disease
排除标准
- •Prior systematic treatment for unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
- •Participation in any anti-cancer, regimen-specified clinical study of first-line treatment for unresectable Stage IIIB or IV NSCLC.
结局指标
主要结局
Demographic and Socio-Behavioral Characteristics
时间窗: At enrollment
Medical History Characteristics
时间窗: At enrollment
Score Tumor Characteristics Based on Tumor Histology, Stage, Grade, and Lung Cancer Molecular Profile
时间窗: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years
Progression-Free Survival (PFS)
时间窗: From enrollment to end of study up to 1.5 years
Treatment Patterns of First-Line and Subsequent Treatments
时间窗: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years
Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status
时间窗: At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years
Overall Survival (OS)
时间窗: From enrollment to end of study up to 1.5 years
次要结局
- Percentage of Non-Serious AEs of Special Interest (AESIs)(From enrollment to end of study up to 1.5 years)
- Percentage of Serious Adverse Events (SAEs)(From enrollment to end of study up to 1.5 years)
- Score Health Economic Status Based on Household Income, Diagnosis and Treatment Costs, and Insurance Coverage(At enrollment, during quarterly and semi-annual follow up and at end of study up to 1.5 years)
- Percentage of Adverse Events (AEs)(From enrollment to end of study up to 1.5 years)