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

  • STATUS
    Recruiting
  • participants needed
    75
  • sponsor
    AstraZeneca
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Updated on 5 August 2020
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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.

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.

Details
Condition Unresectable Stage III NSCLC
Age 18years - 100years
Treatment Multiparametric Mobile Technology
Clinical Study IdentifierNCT04381494
SponsorAstraZeneca
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
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