Effectiveness and Safety of Mobocertinib in Patients With EGFR Exon 20 Insertion NSCLC in Routine Clinical Practice in China: A Prospective, Single-arm, Multicenter, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Real-World Time-to-Treatment Discontinuation (rwTTD)
研究概览
简要总结
The main aim of this study is to learn about the time from start of mobocertinib to end of treatment with mobocertinib for any reason in Chinese adults with lung cancer who carry a certain gene mutation (epidermial growth factor receptor - EGFR exon 20 insertion mutation) during normal clinical practice.
Participants will be treated with mobocertinib as per their normal routine. Data for this study will be collected from the available medical records of a participant.
详细描述
This is a non-interventional, prospective, observational study of participants with EGFR ex20ins positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who received mobocertinib in China's routine clinical practice setting. The primary objective of this study is to assess the real-world time-to-treatment discontinuation (rwTTD) of mobocertinib in study participants.
The study will enroll approximately 120 participants. Participants will be enrolled in the following cohort:
• Mobocertinib
Participants will be treated with mobocertinib as per their normal routine treatment. Data for this study will be collected from the available medical records of a participant every 3 months until the end of treatment and follow up (up to 18 months).
This multi-center trial will be conducted in China. The overall duration of the study will be approximately 3 years.
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
- •Participants with histologically/cytologically confirmed diagnosis of EGFR ex20ins positive locally advanced or metastatic NSCLC by local hospitals.
- •Participants who received mobocertinib as treatment therapy in routine clinical practice; the decision to treat with mobocertinib had to be made independently by physician before enrollment into the study.
- •The decision to treat a participant with mobocertinib had to be made independently by physician before enrollment into the study.
排除标准
- •Participants who are participating in other NSCLC interventional clinical study during the treatment of mobocertinib in this study will be excluded;
- •Other situations that the investigators consider not suitable for participation in this study.
结局指标
主要结局
Real-World Time-to-Treatment Discontinuation (rwTTD)
时间窗: Up to 18 months
Real-world time-to-treatment discontinuation (rwTTD) is defined as the time from initiation of mobocertinib to discontinuation of treatment with mobocertinib for any reason, including disease progression, death, serious adverse events, or participant preference.
次要结局
- Median Real-World Progression-Free Survival (rwPFS)(Up to 18 months)
- TTD Based on Cough per EORTC Quality of Life Questionnaire Lung Cancer module (QLQ-LC13) Scale(Up to 18 months)
- TTD Based on Dyspnea per EORTC QLQ-LC13 Scale(Up to 18 months)
- Real-World Duration of Response (rwDOR)(Up to 18 months)
- Real-World Disease Control Rate (rwDCR)(Up to 18 months)
- Time to Deterioration (TTD) Based on Physical Functioning per European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) (v3.0) Scale(Up to 18 months)
- TTD Based on Chest Pain Scores per EORTC QLQ-LC13 Scale(Up to 18 months)
- Number of Participants Categorized with Clinicopathological Characteristics at Baseline(At Baseline (Day 1))
- Real-World Overall Response Rate (rwORR)(Up to 18 months)
- Real-World PFS (rwPFS) Rate at 1-year, 1.5-year and 2-year(Up to 2 years)
- Number of Participants with Adverse Events (AEs) Related to Mobocertinib(Up to 18 months)
- Real-World Overall Survival (rwOS) Rate at 1-year, 1.5-year and 2-year(Up to 2 years)
- Number of Participants Categorized with Demographic Characteristics at Baseline(At Baseline (Day 1))
- Number of Participants Categorized with Co-Mutation Characteristics at Baseline(At Baseline (Day 1) at the timing of mobocertinib initiation date)