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Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab. | Clinical Trials | Clareo Health

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Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab.

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

NCT04381494•AstraZeneca

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - 130 years

Sex

ALL

Healthy Volunteers

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.

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.

Locations (18)

Research Site

Long Beach, California, United States

Research Site

Santa Ana, California, United States

Research Site

Englewood, Colorado, United States

Research Site

Plainville, Connecticut, United States

Research Site

Boca Raton, Florida, United States

Research Site

Tallahassee, Florida, United States

Research Site

Tampa, Florida, United States

Research Site

Atlanta, Georgia, United States

Research Site

Westwood, Kansas, United States

Research Site

Louisville, Kentucky, United States

Key Dates

Start Date

April 27, 2020

Primary Completion Date

January 27, 2022

Completion Date

January 27, 2022

Last Updated

June 22, 2023

Enrollment

ACTUAL participants

Conditions

Unresectable Stage III NSCLC

Interventions

Multiparametric Mobile Technology

DEVICE

Endostar Combined With Concurrent Radiochemotherapy for Treatment of Unresectable Stage III NSCLC

NCT04161352

Unresectable Stage III NSCLC

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 22, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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