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
iDETECT
1 other identifier
observational
144
1 country
27
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2021
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2021
CompletedFirst Posted
Study publicly available on registry
May 12, 2021
CompletedStudy Start
First participant enrolled
August 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2023
CompletedFebruary 15, 2024
February 1, 2024
1.6 years
May 11, 2021
February 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Grade 2 and higher ILD including radiation pneumonitis
6 months
Secondary Outcomes (1)
Disease progression
6 months
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (27)
Research Site
Nagoya, Aichi-ken, 460-0001, Japan
Research Site
Nagoya, Aichi-ken, 464-8681, Japan
Research Site
Toyoake, Aichi-ken, 470-1192, Japan
Research Site
Matsuyama, Ehime, 791-0280, Japan
Research Site
Ōta, Gunma, 373-8550, Japan
Research Site
Sapporo, Hokkaido, 060-8648, Japan
Research Site
Yokohama, Kanagawa, 232-0024, Japan
Research Site
Yokohama, Kanagawa, 236-0051, Japan
Research Site
Yokohama, Kanagawa, 241-8515, Japan
Research Site
Matsusaka, Mie-ken, 515-8544, Japan
Research Site
Natori-shi, Miyagi, 981-1293, Japan
Research Site
Sendai, Miyagi, 980-0873, Japan
Research Site
Kurashiki, Okayama-ken, 710-8602, Japan
Research Site
Hirakata, Osaka, 573-1191, Japan
Research Site
Sakai, Osaka, 591-8555, Japan
Research Site
Hidaka, Saitama, 350-1298, Japan
Research Site
Kitaadachi-gun Ina, Saitama, 362-0806, Japan
Research Site
Sunto-gun Nagaizumi, Shizuoka, 411-8777, Japan
Research Site
Bunkyo, Tokyo, 113-8603, Japan
Research Site
Bunkyo, Tokyo, 113-8677, Japan
Research Site
Mitaka, Tokyo, 181-8611, Japan
Research Site
Fukuoka, 811-1395, Japan
Research Site
Niigata, 951-8566, Japan
Research Site
Okayama, 700-8558, Japan
Research Site
Osaka, 541-8567, Japan
Research Site
Tokushima, 770-8503, Japan
Research Site
Wakayama, 641-8510, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2021
First Posted
May 12, 2021
Study Start
August 11, 2021
Primary Completion
March 3, 2023
Study Completion
March 3, 2023
Last Updated
February 15, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract fordata accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials/studies via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.