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 : June 18, 2021
|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)|
|Estimated Enrollment :||75 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|
|Estimated Primary Completion Date :||July 30, 2022|
|Estimated Study Completion Date :||July 30, 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).
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
|Contact: AstraZeneca Clinical Study Information Centerfirstname.lastname@example.org|
|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, Iowa|
|Cedar Rapids, Iowa, United States, 52403|
|United States, Kansas|
|Westwood, Kansas, United States, 66205|
|United States, Kentucky|
|Louisville, Kentucky, United States, 40241|
|United States, Massachusetts|
|Worcester, Massachusetts, United States, 01655|
|United States, Michigan|
|Pontiac, Michigan, United States, 48341|
|United States, Minnesota|
|Research Site||Not yet recruiting|
|Rochester, Minnesota, United States, 55905|
|United States, Nebraska|
|Omaha, Nebraska, United States, 68114|
|United States, Nevada|
|Reno, Nevada, United States, 89502|
|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|
|Austin, Texas, United States, 78705|
|Harlingen, Texas, United States, 78550|
|San Antonio, Texas, United States, 78229|
|United States, Virginia|
|Fairfax, Virginia, United States, 22031|
|United States, Washington|
|Lacey, Washington, United States, 98503|
|Tacoma, Washington, United States, 98405|