Carcinoma, Non-Small-Cell LungiDETECTNCT04884269
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
An observational study of Carcinoma, Non-Small-Cell Lung, run by AstraZeneca at 27 sites in Japan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- 144 participants
- Where
- 27 sitesJapan
- Study dates
- 11 Aug 2021to 3 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Japan27 sites
Research Site
Bunkyo, Tokyo, 113-8603
Research Site
Bunkyo, Tokyo, 113-8677
Research Site
Fukuoka, 811-1395
Research Site
Hidaka, Saitama, 350-1298
Research Site
Hirakata, Osaka, 573-1191
Research Site
Kitaadachi-gun Ina, Saitama, 362-0806
Research Site
Kurashiki, Okayama-ken, 710-8602
Research Site
Matsusaka, Mie-ken, 515-8544
Research Site
Matsuyama, Ehime, 791-0280
Research Site
Mitaka, Tokyo, 181-8611
Research Site
Nagoya, Aichi-ken, 460-0001
Research Site
Nagoya, Aichi-ken, 464-8681
Research Site
Natori-shi, Miyagi, 981-1293
Research Site
Niigata, 951-8566
Research Site
Okayama, 700-8558
Research Site
Osaka, 541-8567
Research Site
Ōta, Gunma, 373-8550
Research Site
Sakai, Osaka, 591-8555
Research Site
Sapporo, Hokkaido, 060-8648
Research Site
Sendai, Miyagi, 980-0873
Research Site
Sunto-gun Nagaizumi, Shizuoka, 411-8777
Research Site
Tokushima, 770-8503
Research Site
Toyoake, Aichi-ken, 470-1192
Research Site
Wakayama, 641-8510
Research Site
Yokohama, Kanagawa, 232-0024
Research Site
Yokohama, Kanagawa, 236-0051
Research Site
Yokohama, Kanagawa, 241-8515
About this study
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
Read the 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.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 2 and higher ILD including radiation pneumonitis
Measured: 6 months
Secondary outcomes (1)
Disease progression
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start11 Aug 2021
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884269
- Sponsor's protocol ID
- D4194R00024
- Acronym
- iDETECT
- Status last verified
- Feb 2024
- First submitted
- 11 May 2021
- Last updated
- 15 Feb 2024
- Results posted
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04884269
- Acronym / sponsor ID
- iDETECT / D4194R00024
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Grade 2 and higher ILD including radiation pneumonitis
Time frame: 6 months
1 secondary outcome
Disease progression
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by AstraZeneca at 27 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 2 and higher ILD including radiation pneumonitis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.