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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-27

Study Completion Date

2022-01-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Unresectable Stage III NSCLC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Observational/Other

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.

Group Type OTHER

Multiparametric Mobile Technology

Intervention Type DEVICE

Using a spirometer, an armband, and a tablet to collect data.

Interventions

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Multiparametric Mobile Technology

Using a spirometer, an armband, and a tablet to collect data.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No