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 : Terminated (Study was not terminated for any safety concerns; it was stopped early due to inability to enroll patients in a timely manner and retain patients on study for the entire duration)
First Posted : May 8, 2020
Last Update Posted : April 13, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Unresectable Stage III NSCLC||Device: Multiparametric Mobile Technology||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||January 27, 2022|
|Actual Study Completion Date :||January 27, 2022|
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.
- 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).
- 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.
- Incidences of pulmonary AEs by grade [ Time Frame: up to 12 months ]Number of confirmed pulmonary AEs by grade
- 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.
- 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.
- 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
- 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).
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.
|Ages Eligible for Study:||18 Years to 130 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
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
|United States, California|
|Long Beach, California, United States, 90806|
|Santa Ana, California, United States, 92705|
|United States, Colorado|
|Englewood, Colorado, United States, 80113|
|United States, Connecticut|
|Plainville, Connecticut, United States, 06062|
|United States, Florida|
|Boca Raton, Florida, United States, 33486|
|Tallahassee, Florida, United States, 32308|
|Tampa, Florida, United States, 33612|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Kansas|
|Westwood, Kansas, United States, 66205|
|United States, Kentucky|
|Louisville, Kentucky, United States, 40241|
|United States, Michigan|
|Pontiac, Michigan, United States, 48341|
|United States, New York|
|New York, New York, United States, 10029|
|United States, Ohio|
|Cincinnati, Ohio, United States, 45267|
|Massillon, Ohio, United States, 44646|
|United States, Tennessee|
|Knoxville, Tennessee, United States, 37916|
|United States, Texas|
|San Antonio, Texas, United States, 78229|
|United States, Washington|
|Lacey, Washington, United States, 98503|
|Tacoma, Washington, United States, 98405|
|Other Study ID Numbers:||
|First Posted:||May 8, 2020 Key Record Dates|
|Last Update Posted:||April 13, 2022|
|Last Verified:||April 2022|
|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.|
Statistical Analysis Plan (SAP)
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:
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:
|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|
Non-Small Cell Lung Cancer
Respiratory Tract Infections
Respiratory Tract Diseases