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)

February 14, 2024 updated by: AstraZeneca
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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 811-1395
        • Research Site
      • Niigata, Japan, 951-8566
        • Research Site
      • Okayama, Japan, 700-8558
        • Research Site
      • Osaka, Japan, 541-8567
        • Research Site
      • Tokushima, Japan, 770-8503
        • Research Site
      • Wakayama, Japan, 641-8510
        • Research Site
    • Aichi
      • Nagoya, Aichi, Japan, 460-0001
        • Research Site
      • Nagoya, Aichi, Japan, 464-8681
        • Research Site
      • Toyoake, Aichi, Japan, 470-1192
        • Research Site
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • Research Site
    • Gunma
      • Ota, Gunma, Japan, 373-8550
        • Research Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Research Site
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 232-0024
        • Research Site
      • Yokohama, Kanagawa, Japan, 236-0051
        • Research Site
      • Yokohama, Kanagawa, Japan, 241-8515
        • Research Site
    • Mie
      • Matsusaka, Mie, Japan, 515-8544
        • Research Site
    • Miyagi
      • Natori, Miyagi, Japan, 981-1293
        • Research Site
      • Sendai, Miyagi, Japan, 980-0873
        • Research Site
    • Okayama
      • Kurashiki, Okayama, Japan, 710-8602
        • Research Site
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Research Site
      • Sakai, Osaka, Japan, 591-8555
        • Research Site
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Research Site
      • Kitaadachi-gun Ina, Saitama, Japan, 362-0806
        • Research Site
    • Shizuoka
      • Sunto-gun Nagaizumi, Shizuoka, Japan, 411-8777
        • Research Site
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8603
        • Research Site
      • Bunkyo, Tokyo, Japan, 113-8677
        • Research Site
      • Mitaka, Tokyo, Japan, 181-8611
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Grade 2 and higher ILD including radiation pneumonitis
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease progression
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2021

Primary Completion (Actual)

March 3, 2023

Study Completion (Actual)

March 3, 2023

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4194R00024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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