A Real-World Study to Evaluate the Effectiveness and Safety of Brigatinib in First Line in Patients With ALK Positive Locally Advanced or Metastatic NSCLC in China: An Ambispective, Non-interventional, Observational, Multi-center Study.
概览
- 阶段
- 不适用
- 干预措施
- Brigatinib
- 疾病 / 适应症
- Non-small Cell Lung Cancer (NSCLC)
- 发起方
- Takeda
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Real-World Time-to-Treatment Discontinuation (rwTDD)
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
The main aim of this study is to learn about the time between the start and stop of treatment with brigatinib in Chinese participants with non-small-cell lung cancer (NSCLC) and who have been positively diagnosed with having the anaplastic lymphoma kinase (ALK) gene. Other study aims are to learn about the progression of NSCLC and participants' response to treatment with brigatinib.
详细描述
This is a non-interventional, ambispective (retrospective + prospective) study of Chinese participants with ALK-positive locally advanced or metastatic NSCLC receiving brigatinib as their first line of treatment from September 1, 2022.This study will evaluate the time-to-treatment discontinuation and other efficacy outcomes of brigatinib in participants with NSCLC in real-world settings. This study will enroll approximately 200 participants in the following cohort: • Brigatinib 90 mg/180mg This study is an ambispective study that will have prospective data collection if participants enrolled after the study initiation or it will have retrospective data collection if the participants have already started receiving brigatinib as first line treatment before study initiation. This multi-center trial will be conducted in China. Participants will be followed up for safety from signing informed consent until 36 months after the last dose of treatment or until death of the last participant. The overall time for data collection is approximately 8 years.
研究者
入排标准
入选标准
- •Age ≥ 18 years.
- •Participant with histologically/cytologically confirmed locally advanced or metastatic NSCLC.
- •Participants with ALK gene rearrangement confirmed by local hospital medical records.
- •Participants who received brigatinib since September 1, 2022 as first line treatment confirmed by medical records.
- •Participants who have at least one medical record after the start of brigatinib treatment.
排除标准
- •Participants participated in NSCLC-related interventional clinical trials after locally advanced or metastatic NSCLC diagnosis and during brigatinib treatment.
- •Previously received any other TKIs, including ALK-targeted TKIs.
- •Previously received more than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease.
- •Participants have been diagnosed as malignancies (excluding completely resected basal cell carcinoma, bladder carcinoma in situ, cervical carcinoma in situ) in addition to NSCLC within the past 5 years.
研究组 & 干预措施
Brigatinib 90 mg/180mg
Participants with ALK positive locally advanced or metastatic NSCLC will be observed ambispectively (retrospective plus prospective) after receiving recommended dose of brigatinib, 90 mg orally once daily for first 7 days followed by 180 mg once daily for up to 36 months as their first line of treatment as part of routine medical care. Data will be collected every 3 months after their first dose until the 36 month or participant death, loss to follow-up, or withdrawal from the study for any reason in the real-world setting from September 1, 2022.
干预措施: Brigatinib
结局指标
主要结局
Real-World Time-to-Treatment Discontinuation (rwTDD)
时间窗: Up to 8 years
rwTTD is defined as the time from initiation of brigatinib to discontinuation of treatment for any reason, including disease progression, death, serious adverse events, or participant preference.
次要结局
- Real-World Progression-Free Survival at Years 1, 2 and 3(Up to 8 years)
- Real-World Overall Survival (rwOS) at Years 1, 2 and 3(Up to 8 years)
- Real-World Progression-Free Survival (rwPFS)(Up to 8 years)
- Real-World Objective Response Rate (rwORR)(Up to 8 years)
- Real-World Duration of Response (rwDOR)(Up to 8 years)