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

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

Recruiting
18 years and older
All
Phase 4

Overview

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.

Eligibility

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.

Study details
    Unresectable Stage III NSCLC

NCT04381494

AstraZeneca

5 August 2020

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