Treatment Patterns and Real-World Clinical Outcomes in Patients With Advanced NSCLC and MET Exon 14 Skipping Mutation in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 1
- 主要终点
- Real-world overall response rate (rwORR)
研究概览
简要总结
This was a retrospective, noninterventional cohort study of patients with a confirmed diagnosis of advanced non-small cell lung cancer (aNSCLC) with MET exon 14 skipping mutation who received treatment with capmatinib, immunotherapy (IO), or chemotherapy (CT) in real-world practice settings. Data abstraction was performed by the participating physician.
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
- •Patient was aged ≥ 18 years at the time of NSCLC diagnosis.
- •Had histologically confirmed advanced (stage IIIB, IIIC, or IV) NSCLC with MET exon 14 skipping mutation.
- •Initiated first-line (1L) treatment for aNSCLC between 1 January 2017 and date of data abstraction with one of the following treatment regimen:
- •Capmatinib
- •IO agent in monotherapy (e.g., atezolizumab, pembrolizumab)
- •CT regimen, single agent or combinations of CT agents (e.g., platinum agents, taxane agents, gemcitabine, pemetrexed)
- •Combination regimen containing IO and CT agents
- •Had ≥ 6 months of potential follow-up time after the initiation of 1L treatment for aNSCLC, except if the patient died sooner.
- •Living or deceased at the time of chart abstraction.
排除标准
- •Presence of other mutations (e.g., EGFR, ALK, ROS1, RET, NTRK, BRAF, or KRAS) at any time.
- •Treatment with other MET inhibitors such as crizotinib or tepotinib at any time during the study period.
- •Participation in clinical trials related to treatment for NSCLC at any timepoint.
结局指标
主要结局
Real-world overall response rate (rwORR)
时间窗: Up to approximately 5 years
Proportion of patients with best overall response of either a complete response (CR) or partial response (PR) to the line of therapy based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or per healthcare professional (HCP) assessment.
Real-world disease control rate (rwDCR)
时间窗: Up to approximately 5 years
Proportion of patients with best overall response of either a CR+PR or stable disease to the line of therapy based on RECIST version 1.1, or per HCP assessment.
Real-world progression-free survival (rwPFS)
时间窗: Up to approximately 5 years
Time from start of therapy until the earliest of a clinically documented systemic disease progression.
Time-to-treatment discontinuation (TTD)
时间窗: Up to approximately 5 years
Real-world duration of response (rwDOR)
时间窗: Up to approximately 5 years
Time from the date of first documented CR or PR to the first documented systemic disease progression or death due to any cause.
Overall survival (OS)
时间窗: Up to approximately 5 years
Time from start of therapy until death.
次要结局
- Number of patients per demographic category(Baseline)
- Number of patients per clinical characteristic category(Baseline)
- Mean age(Baseline)
- Number of patients per comorbidity(Up to 6 months pre-baseline)