Clinical trial NCT04381494: Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab.
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Unresectable Stage III NSCLC
Keywords: NSCLC
Non-Small Cell Lung Cancer
durvalumab
Stage III
Stage IIIA
Spirometer
Spirometry
PROs
Mobile Applications
Digital Applications
Stage IIIB
Stage IIIC
Device
Parametric
Pneumonitis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2020-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed 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 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Event (TEAE) of Pneumonitis by Grade
timeFrame: TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
Secondary outcomes:
measure: Number of Participants With Permanent Discontinuation of Durvalumab Due to Pulmonary TEAEs
timeFrame: TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
measure: Duration of Durvalumab Treatment
timeFrame: Up to Month 12
measure: Number of Participants With Early Discontinuation of Durvalumab
timeFrame: Up to Month 12
measure: Number of Participants With Treatment Interruptions
timeFrame: Up to Month 12
measure: Duration of Durvalumab Treatment Interruption
timeFrame: Up to Month 12
measure: Number of Participants With Pulmonary TEAEs Excluding Pneumonitis
timeFrame: TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
measure: Duration of Pulmonary TEAEs Excluding Pneumonitis
timeFrame: TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
measure: Number of Participants Who Received Prescription Medication to Manage Pneumonitis TEAEs
timeFrame: Up to Month 12
measure: Duration of Prescription Medication Received by Participants to Manage Pneumonitis TEAEs
timeFrame: Up to Month 12
measure: Duration of Development of Grade 3 to Grade 5 TEAEs, Including Pneumonitis
timeFrame: TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30) in Participants With Pneumonitis TEAEs
timeFrame: Baseline visit (Day 1), every 2 weeks for the first 3 months and once monthly thereafter, and at End-of-Study visit (Month 12)
measure: Change From Baseline in EORTC QLQ-Lung Cancer (LC)13 in Participants With Pneumonitis TEAEs
timeFrame: Baseline visit (Day 1), every 2 weeks for the first 3 months and once monthly thereafter, and at End-of-Study visit (Month 12)
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Research Site
state: California
city: Santa Ana
country: United States
facility: Research Site
state: California
city: Englewood
country: United States
facility: Research Site
state: Colorado
city: Plainville
country: United States
facility: Research Site
state: Connecticut
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Tallahassee
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Westwood
country: United States
facility: Research Site
state: Kansas
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Pontiac
country: United States
facility: Research Site
state: Michigan
city: New York
country: United States
facility: Research Site
state: New York
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Massillon
country: United States
facility: Research Site
state: Ohio
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Lacey
country: United States
facility: Research Site
state: Washington
city: Tacoma
country: United States
facility: Research Site
state: Washington
Study officials:
References: