Retrospective Chart Review and Historical Comparison of Capmatinib vs. Standard of Care for German Adult Patients With Locally Advanced or Metastatic NSCLC Harboring METex14 Mutations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
The objective of the study was to compare the therapeutic benefit of capmatinib versus appropriate comparative therapy (ACT) defined by the German HTA agency G-BA for its benefit assessment of capmatinib but also versus the standard of care (SoC) practiced in German routine care. Due to its design as an adjusted, patient-level comparison, the RECAP study addresses the evidence gap due to the single-arm nature of pivotal evidence for capmatinib.
For this purpose, data on patients treated with ACT resp. SoC in German routine care has been collected via a retrospective chart review. This data was then used as an external control for a non-randomized, patient-level adjusted comparison with data from the GEOMETRY mono-1 study of capmatinib (NCT02414139).
Due to the non-interventional nature of this study, the definition of endpoints as primary or secondary was omitted formally.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
Overall response rate (ORR)
时间窗: Up to an average of approximately 18 months
For external control patients, ORR was defined as proportion of patients with a radiologically documented decrease in sum of tumor lesions (primary tumor and metastases). Decrease in sum of tumor lesions included complete cessation of any radiologically detectable tumor lesions. For GEOMETRY mono-1 patients, ORR was defined as proportion of patients with a best overall response as complete response (CR) or partial response (PR). CR and PR were assessed per RECIST 1.1 by BIRC. Per the protocol and due to the non-interventional nature of this study, outcome measures were not formally ranked as primary or secondary.
Overall survival (OS)
时间窗: Up to an average of approximately 18 months
OS was defined as time from start of treatment to death due to any cause. Per the protocol and due to the non-interventional nature of this study, outcome measures were not formally ranked as primary or secondary.
Progression-free survival (PFS)
时间窗: Up to an average of approximately 18 months
PFS was defined as time from start of treatment to first documented disease progression or death due to any cause. Per the protocol and due to the non-interventional nature of this study, outcome measures were not formally ranked as primary or secondary.
Time to central nervous system (CNS) progression (CNSprog)
时间窗: Up to an average of approximately 18 months
For patients without brain metastases at start of treatment, CNSprog was defined as time from start of treatment to first radiologically documented brain metastases. Per the protocol and due to the non-interventional nature of this study, outcome measures were not formally ranked as primary or secondary.
次要结局
未报告次要终点