Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
20+ years
Brief Summary
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 progres...
Detailed Description
Study design: Multicentre, prospective, non-interventional pilot study Data Source(s): Medical records, wearable devices, and mobile application. Study Population:Patients treated durvalumab followi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 3 2023
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04884269
Start Date
August 11 2021
End Date
March 3 2023
Last Update
February 15 2024
Active Locations (27)
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1
Research Site
Nagoya, Aichi-ken, Japan, 460-0001
2
Research Site
Nagoya, Aichi-ken, Japan, 464-8681
3
Research Site
Toyoake, Aichi-ken, Japan, 470-1192
4
Research Site
Matsuyama, Ehime, Japan, 791-0280