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

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

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

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.

Sample Size Estimations : 150 patients

Statistical Analysis: Continuous variables will be reported as mean, median, standard deviation, IQR, maximum, and minimum. Categorical variables will be summarized as absolute frequency and percentage. Ninety-five percent confidence intervals (CIs) will be presented where appropriate. Time-to event for ILD/Disease progression will be estimated by Kaplan-Meir method. Also, in the process of developing model, data production such as per-patient plots of the physiological data(multivariate time series) and physiological data before and after (in a shorter time-scale) the ILD event per event will be considered.

Inclusion Criteria:

• 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 Criteria:

• 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