Understanding Non-small Cell Lung Cancer (NSCLC) Patient Characteristics, Treatment Patterns and Outcomes Via Cross-sEctional Physicians suRvey-based Chart Audit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 833
- 试验地点
- 1
- 主要终点
- Outcomes of interest are real-world overall survival (rwOS)
研究概览
简要总结
This is a retrospective, cross-sectional, non-interventional, multi-country survey-based chart audit study to evaluate real-world treatment patterns, patient clinical profiles, and clinical outcomes among a NSCLC patients receiving at least 1L SACT (Systemic anticancer therapy)
详细描述
This is a retrospective, cross-sectional, non-interventional, multi-country survey-based chart audit study to evaluate real-world treatment patterns, patient clinical profiles, and clinical outcomes among aNSCLC patients receiving at least 1L SACT in Argentina, Brazil, Mexico, Australia, India, Taiwan, Malaysia, Hong Kong, and Turkey. All patient-level data, including patient demographic and clinical characteristics, treatment history, and clinical outcomes, will be collected retrospectively from existing patient medical records provided by participating physicians, without interference with treatment decisions. Informed consent from individual patients will not be required, as this study describes the analysis of deidentified patient data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Eligibility Criteria - Inclusion Criteria Diagnosis: Confirmed de novo stage IIIB, IIIC, or IV NSCLC.
- •Biomarker Status:
- •Either: EGFR mutation present Or: No actionable gene alterations (AGAs) detected (including EGFR, ALK, ROS1, NTRK, BRAF V600E, RET, MET, KRAS, HER2; patients not tested for these also eligible).
- •Treatment Start Window: Initiated 1L SACT (systemic anticancer therapy) for advanced NSCLC between the date of first Tagrisso® (osimertinib) approval for NSCLC in their country and 31 December
- •Age: 18 years or older at time of 1L SACT initiation.
排除标准
- •Concurrent Malignancies: Patients on active treatment for another primary malignancy at 1L SACT initiation.
结局指标
主要结局
Outcomes of interest are real-world overall survival (rwOS)
时间窗: 12 month
Definition of rwOS rwOS is defined as the interval between the index date and the date of death due to any cause. \*Patients who are alive or for whom vital status is unknown at the time of data collection will be censored at the date the patient is last known to be alive.
次要结局
未报告次要终点