A Real-world Study to Explore Therapeutic Changing Mode of Locally Therapy During 1L Lorlatinib Treatment in Unresectable ALK+ NSCLC Patients
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
- Time-to treatment discontinuation (TTD)
研究概览
简要总结
This real-word study is designed to prospectively explore whether local treatment (surgery, ablation, radiotherapy and others) can prolong the time to treatment discontinuation during 1L lorlatinib treatment in Chinese patients with unresectable ALK+ NSCLC. Participation in this study is not intended to change the routine treatment received as determined by their attending physicians. Patients will be treated according to the routine medical practice in terms of visit frequency and types of assessments performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Time-to treatment discontinuation (TTD)
时间窗: From November 2024 to April 2027
Time-to treatment discontinuation is defined as the time from start of treatment to the date of discontinuation of these therapeutic methods.
次要结局
- Objective Response Rate (ORR)(From November 2024 to April 2027)
- Duration of response (DOR)(From November 2024 to April 2027)
- Time to Progression (TTP)(From November 2024 to April 2027)
- Intracranial Objective Response Rate (IC-ORR)(From November 2024 to April 2027)
- Intracranial Time to Progression (IC-TTP)(From November 2024 to April 2027)
- Overall Survival (OS)(From November 2024 to April 2027)
- Safety: To explore the adverse events (AEs), the dose modification and the reason for interruption or discontinuation of lorlatinib in first line for Chinese patients with ALK-positive locally advanced or metastatic NSCLC recorded in medical records(From November 2024 to April 2027)
- Proportion of patients experiencing a 10-points change from baseline in total score for the EORTC QLQ-C30(From November 2024 to April 2027)
- Dynamic molecular response(From November 2024 to April 2027)
- Safety and tolerability of the therapeutic changing mode(From November 2024 to April 2027)
研究者
Jun Zhao
Deputy Director of Thoracic Cancer Center;
Peking University Cancer Hospital & Institute