Carcinoma, Non-Small-Cell Lung
Conditions
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade 2 and higher ILD including radiation pneumonitis | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Disease progression | 6 months |
Countries
Japan
Outcome results
None listed