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Trial record 1 of 1 for:    NCT04381494
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Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab. (ON TRAX)

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ClinicalTrials.gov Identifier: NCT04381494
Recruitment Status : Recruiting
First Posted : May 8, 2020
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
A study of whether mobile devices can improve the detection of pulmonary AEs (including pneumonitis) in stage III NSCLC patients post-CRT, while on durvalumab.

Condition or disease Intervention/treatment Phase
Unresectable Stage III NSCLC Device: Multiparametric Mobile Technology Phase 4

Detailed Description:

Patients undergoing post-CRT treatment for lung cancer with consolidation durvalumab can experience pulmonary AEs that could become severe if not recognized and treated in time.

Data collected will be used to evaluate the likelihood of early detection of pulmonary AEs in unresectable Stage III NSCLC patients on durvalumab. This project seeks to understand if multiparametric mobile technology collecting patient reported outcomes, vital signs, and respiratory function, integrate well into a patients daily life and aid physicians in early detection of pulmonary AEs.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prospective, Interventional Pilot Study of Mobile Devices and Digital Applications to Detect Early Pneumonitis and Other Pulmonary Adverse Events in Unresectable Stage III Non-Small Cell Lung Cancer Patients on Durvalumab
Actual Study Start Date : April 27, 2020
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : July 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Durvalumab

Arm Intervention/treatment
Observational/Other
Patients will be enrolled after their treating physician has prescribed durvalumab and before they start durvalumab treatment. Patients will receive mobile and wearable devices alongside their durvalumab treatment without any additional interventions.
Device: Multiparametric Mobile Technology
Using a spirometer, an armband, and a tablet to collect data.




Primary Outcome Measures :
  1. Total number of confirmed pneumonitis cases by grade & number of cases identified early through mobile technology [ Time Frame: up to 12 months ]
    To describe the identification of treatment-emergent pneumonitis by grade (regardless of radiation therapy and/or immune-related etiology) in patients with unresectable Stage III NSCLC receiving durvalumab through the use of mobile technology which collects patient reported outcomes (PROs), vital signs (temperature, heart rate, respiratory rate), oxygen saturation (pulse oximetry), pulmonary function tests (spirometry), and physical movement (number of steps per day).


Secondary Outcome Measures :
  1. Number of patients discontinued early from durvalumab treatment for any reason. [ Time Frame: up to 12 months ]

    Number of patients permanently discontinued from durvalumab treatment due to pulmonary AEs including pneumonitis.

    Number of patients discontinued early from durvalumab treatment for any reason.


  2. Incidences of pulmonary AEs by grade [ Time Frame: up to 12 months ]
    Number of confirmed pulmonary AEs by grade

  3. Quality of life (QoL): Assessment of general cancer-associated parameters by use of European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire - Core 30 (EORTC QLQ-C30) [ Time Frame: up to 12 months ]
    The EORTC QLQ-C30 consists of 30 questions that can be combined to produce functional scales (e.g. physical), symptom scales (e.g. fatigue), and a global measure of health status. Each of the scales are measured from 0 to 100. The EORTC QLQ-C30 will be scored according to the EORTC QLQ-C30 Scoring Manual (Fayers et al. 2001). Higher scores on the global measure of health status and functional scales indicate better health status/function, but higher scores on symptom scales/scores represent greater symptom severity. Changes from baseline scores will be assessed.

  4. Quality of life (QoL): Assessment of lung cancer associated parameters by use of European Organisation For Research And Treatment Of Cancer Quality Of Life Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13) [ Time Frame: up to 12 months ]
    The EORTC QLQ-LC13 is a lung cancer specific module from the EORTC comprising 13 questions to assess lung cancer symptoms (dyspnoea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and haemoptysis). Scores from 0 to 100 were derived for each symptom item with higher scores indicating a higher level of symptomatology/problems. Changes from baseline scores will be assessed.


Other Outcome Measures:
  1. Quantify patient experience with the multiparametric mobile devices and applications by using a customized end user questionnaire [ Time Frame: up to 12 months ]
    Quantify patient experience by using a customized end user questionnaire that captures experience with devices and applications used in the study

  2. Quantify physician experience with data dashboard by using a customized end user questionnaire [ Time Frame: up to 12 months ]
    Quantify physician experience by using a customized end user questionnaire that captures experience with data dashboard (real-time and retrospective review of the data provided by the multiparametric mobile devices used in the study).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Select Inclusion Criteria:

  • Patient has unresectable Stage III NSCLC that has not progressed following concurrent platinum-based chemotherapy and radiation therapy and is eligible to receive durvalumab according to the US FDA approved package insert.
  • Patient is able and willing to use the mobile application and connected devices.
  • Patient is able to complete QoL assessments.

Select Exclusion Criteria:

  • Patient is currently oxygen dependent.
  • Patient has comorbidities that will prevent consistent and reliable measurement assessments with multiparametric mobile technology including severe chronic obstructive pulmonary disorder (COPD), severe asthma, congestive heart failure [CHF], interstitial lung disease [ILD], and others.
  • Patients on other immunotherapy or systemic immunosuppressants.
  • Patients with active or prior autoimmune disease or history of immunodeficiency.
  • Currently pregnant women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381494


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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United States, California
Research Site Not yet recruiting
Long Beach, California, United States, 90806
Research Site Recruiting
Santa Ana, California, United States, 92705
United States, Colorado
Research Site Not yet recruiting
Aurora, Colorado, United States, 80045
Research Site Recruiting
Golden, Colorado, United States, 80401
United States, Florida
Research Site Not yet recruiting
Boca Raton, Florida, United States, 33486
Research Site Not yet recruiting
Tallahassee, Florida, United States, 32308
Research Site Not yet recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Research Site Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Research Site Suspended
Park Ridge, Illinois, United States, 60068
United States, Kansas
Research Site Recruiting
Westwood, Kansas, United States, 66226
United States, Kentucky
Research Site Not yet recruiting
Louisville, Kentucky, United States, 40241
United States, Massachusetts
Research Site Not yet recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
Research Site Not yet recruiting
Pontiac, Michigan, United States, 48341
United States, Nebraska
Research Site Recruiting
Omaha, Nebraska, United States, 68114
United States, Nevada
Research Site Recruiting
Reno, Nevada, United States, 89502
United States, New York
Research Site Not yet recruiting
New York, New York, United States, 10029
United States, Ohio
Research Site Not yet recruiting
Cincinnati, Ohio, United States, 45267
Research Site Not yet recruiting
Massillon, Ohio, United States, 44646
United States, Pennsylvania
Research Site Not yet recruiting
Bethlehem, Pennsylvania, United States, 18015
Research Site Suspended
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Research Site Not yet recruiting
Knoxville, Tennessee, United States, 37916
United States, Texas
Research Site Not yet recruiting
Austin, Texas, United States, 78705
Research Site Not yet recruiting
Dallas, Texas, United States, 75203
Research Site Recruiting
Harlingen, Texas, United States, 78550
Research Site Recruiting
San Antonio, Texas, United States, 78229
United States, Utah
Research Site Suspended
Salt Lake City, Utah, United States, 84112
United States, Virginia
Research Site Not yet recruiting
Alexandria, Virginia, United States, 22031
United States, Washington
Research Site Not yet recruiting
Lacey, Washington, United States, 98503
Sponsors and Collaborators
AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04381494    
Other Study ID Numbers: D4194C00008
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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 for data 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.

URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AstraZeneca:
NSCLC
Non-Small Cell Lung Cancer
durvalumab
Stage III
Stage IIIA
Spirometer
Spirometry
PROs
Mobile Applications
Digital Applications
Stage IIIB
Stage IIIC
Device
Parametric
Pneumonitis
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections