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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

NCT04884269

CompletedN/A

Sponsor: AstraZeneca

Conditions: Carcinoma, Non-Small-Cell Lung

Countries: Japan

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

Eligibility overview

Sex: ALL

Age: 20 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (27)

Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Toyoake, Aichi-ken, Japan
Matsuyama, Ehime, Japan
Ōta, Gunma, Japan
Sapporo, Hokkaido, Japan
Yokohama, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Matsusaka, Mie-ken, Japan
Natori-shi, Miyagi, Japan
Sendai, Miyagi, Japan
Kurashiki, Okayama-ken, Japan
Hirakata, Osaka, Japan
Sakai, Osaka, Japan
Hidaka, Saitama, Japan
Kitaadachi-gun Ina, Saitama, Japan
Sunto-gun Nagaizumi, Shizuoka, Japan
Bunkyo, Tokyo, Japan
Bunkyo, Tokyo, Japan
Mitaka, Tokyo, Japan
Fukuoka, Japan
Niigata, Japan
Okayama, Japan
Osaka, Japan
Tokushima, Japan
Wakayama, Japan