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
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT1051210033
- Lead Sponsor
- Kouda Shigetaka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
1.Patient who provided written signed informed consent prior to the first study-specific procedures.
2.Patient who receives durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy
3.Patient whose performance status showed 0 or 1 prior to durvalumab treatment
4.Patient aged 20 age old over
5.Patient who is able and willing to wear the devices daily for up to 6 months as instructed
1. Patient under immunotherapy treatment other than durvalumab.
2. Patient had received prior immunotherapy
3. Patient under the interventional clinical studies using unapproved drugs or off-label use of drugs
4. Patient who showed ILD (including radiation pneumonitis) of Grade 2 and higher, after consolidated chemoradiation therapy.
5.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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Grade 2 and higher ILD including radiation pneumonitis
- Secondary Outcome Measures
Name Time Method Disease progression