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

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