A Non Interventional Pilot Study on Machine Learning for ILD Detection Based on the Patient Data From Digital Devices in Unresectable Stage III Non-Small Cell Lung Cancer Patients Receiving Durvalumab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Grade 2 and higher ILD including radiation pneumonitis
研究概览
简要总结
Objective in this study is to investigate feasibility of developing machine-learning based model for the identification of future development of diagnosed Grade 2 and higher ILD and of disease progression in patients with unresectable Stage III NSCLC receiving durvalumab
详细描述
Study design: Multicentre, prospective, non-interventional pilot study
Data Source(s): Medical records, wearable devices, and mobile application.
Study Population:Patients treated durvalumab following chemoradiation therapy for stage III unresectable NSCLC in Japan from the June 2021 to June 2022. They must fulfil all of the inclusion /exclusion criteria.
Exposure(s): dulvalumab
Outcome(s): Disease progression, ILD including radiation pneumonitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who provided written signed informed consent prior to the first study-specific procedures.
- •Patient who receives durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy
- •Patient whose performance status showed 0 or 1 prior to durvalumab treatment
- •Patient who is able and willing to wear the devices daily for up to 6 months as instructed
排除标准
- •Patient under immunotherapy treatment other than durvalumab.
- •Patient had received prior immunotherapy
- •Patient under the interventional clinical studies using unapproved drugs or off-label use of drugs
- •Patient who showed ILD (including radiation pneumonitis) of Grade 2 and higher, after consolidated chemoradiation therapy.
- •Patient who is judged as not suitable for the study by the study site investigators, in terms of fitting wearable devices, presence of silicone or metallic allergy
结局指标
主要结局
Grade 2 and higher ILD including radiation pneumonitis
时间窗: 6 months
次要结局
- Disease progression(6 months)