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

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT04884269
• Lead Sponsor: AstraZeneca

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 progression in patients with unresectable Stage III NSCLC receiving durvalumab

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 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.

Study Timeline

• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-12
• Study Start: 2021-08-11
• Primary Completion: 2023-03-03
• Study Completion: 2023-03-03
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Grade 2 and higher ILD including radiation pneumonitis	6 months

Secondary Outcome Measures

Name	Time	Method
Disease progression	6 months

Trial Locations

Locations (1)

Research Site; 🇯🇵 Wakayama, Japan