Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab. (ON TRAX)

AstraZeneca logo

AstraZeneca

Status and phase

Terminated
Phase 4

Conditions

Unresectable Stage III NSCLC

Treatments

Device: Multiparametric Mobile Technology

Study type

Interventional

Funder types

Industry

Identifiers

NCT04381494
D4194C00008

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 130 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Observational/Other
Other group
Description:
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.
Treatment:
Device: Multiparametric Mobile Technology

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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