Clinical trial NCT04884269: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-05-12
Enrollment: 144
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of stage III unresectable NSCLC patients treated durvalumab following chemoradiation therapy in Japan from the June 2021 to June 2022. They must fulfil all of the following inclusion /exclusion criteria.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Grade 2 and higher ILD including radiation pneumonitis
timeFrame: 6 months
Secondary outcomes:
measure: Disease progression
timeFrame: 6 months
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Toyoake
country: Japan
facility: Research Site
state: Aichi
city: Matsuyama
country: Japan
facility: Research Site
state: Ehime
city: Ota
country: Japan
facility: Research Site
state: Gunma
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Matsusaka
country: Japan
facility: Research Site
state: Mie
city: Natori
country: Japan
facility: Research Site
state: Miyagi
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Kurashiki
country: Japan
facility: Research Site
state: Okayama
city: Hirakata
country: Japan
facility: Research Site
state: Osaka
city: Sakai
country: Japan
facility: Research Site
state: Osaka
city: Hidaka
country: Japan
facility: Research Site
state: Saitama
city: Kitaadachi-gun Ina
country: Japan
facility: Research Site
state: Saitama
city: Sunto-gun Nagaizumi
country: Japan
facility: Research Site
state: Shizuoka
city: Bunkyo
country: Japan
facility: Research Site
state: Tokyo
city: Bunkyo
country: Japan
facility: Research Site
state: Tokyo
city: Mitaka
country: Japan
facility: Research Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Tokushima
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
Study officials:
References: