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Clinical Trial 20528

Cancer Type: Thoracic
Study Type: Device Feasibility
NCT#: NCT04381494

Phase: N/A
Prinicipal Investigator: Andreas Saltos

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Overview

Study 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

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.

Objective

Primary Objective: 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) Secondary Objectives: To describe durvalumab treatment discontinuation due to pulmonary AEs,including pneumonitis To describe the duration of durvalumab use To describe the incidence of pulmonary AEs by grade To describe the severity of pulmonary AEs (including pneumonitis) and use of medication to manage AEs To describe the time to development of Grade 3 to 5 AEs, including pneumonitis To describe health-related quality of life (QoL) during the study and its relationship with AEs Exploratory Objectives: To describe the patients experience with the device(s) and application(s) used in the study To describe the physician s experience with the dashboard and data provided by the devices used in the study To incorporate data collected from positive results to evaluate the potential development of an algorithm to detect pneumonitis in subsequent (future) studies To determine the importance of different variables in discriminating between pneumonitis and other pulmonary AEs

Treatments

Therapies

Medications

Inclusion Criteria

Inclusion Criteria:

  • 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.
  • Able and willing to use the mobile application and connected devices.
  • Able to complete QoL assessments.

  • Exclusion Criteria

    Exclusion Criteria:

  • Patient is currently oxygen dependent.
  • 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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