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

JRCT ID: jRCT1051210033

Registered date:02/06/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-Small Cell Lung Cancer
• Date of first enrollment: 10/08/2021
• Target sample size: 150
• Study type: Observational

Outcome(s)

• Primary Outcome: Grade 2 and higher ILD including radiation pneumonitis
• Secondary Outcome: Disease progression

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patient who provided written signed informed consent prior to the first study-specific procedures.
2.Patient who receives durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy
3.Patient whose performance status showed 0 or 1 prior to durvalumab treatment
4.Patient aged 20 age old over
5.Patient who is able and willing to wear the devices daily for up to 6 months as instructed

Exclude criteria

1. Patient under immunotherapy treatment other than durvalumab.
2. Patient had received prior immunotherapy
3. Patient under the interventional clinical studies using unapproved drugs or off-label use of drugs
4. Patient who showed ILD (including radiation pneumonitis) of Grade 2 and higher, after consolidated chemoradiation therapy.
5.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

Related Information

• Primary Sponsor: Kouda Shigetaka
• Source(s) of Monetary Support: AstraZeneca K.K.
• Secondary ID(s): NCT04884269