Study Stopped
Study was not terminated for any safety concerns; it was stopped early due to inability to enroll patients in a timely manner and retain patients on study for the entire duration
Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab.
ON TRAX
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
1 other identifier
interventional
40
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2020
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2020
CompletedStudy Start
First participant enrolled
April 27, 2020
CompletedFirst Posted
Study publicly available on registry
May 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2022
CompletedResults Posted
Study results publicly available
June 22, 2023
CompletedJune 22, 2023
May 1, 2023
1.8 years
April 2, 2020
January 24, 2023
May 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-Emergent Adverse Event (TEAE) of Pneumonitis by Grade
An AE was occurrence of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product or device, whether or not considered causally related to the product or device medical occurrence in a participant. The TEAEs of pneumonitis were defined as any pneumonitis event that occurred or worsened at any time after the start of administration of the first dose of durvalumab and through 30 days after the last dose of durvalumab. Severity (intensity of any event) was assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse events (CTCAE) v5. The AEs were assigned to a Grade from 1 through 5 as follows: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening requiring hospitalization; Grade 4: Life-threatening consequences; Grade 5: Death due to any AE.
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 (12)
Number of Participants With Permanent Discontinuation of Durvalumab Due to Pulmonary TEAEs
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
Duration of Durvalumab Treatment
Up to Month 12
Number of Participants With Early Discontinuation of Durvalumab
Up to Month 12
Number of Participants With Treatment Interruptions
Up to Month 12
Duration of Durvalumab Treatment Interruption
Up to Month 12
- +7 more secondary outcomes
Study Arms (1)
Observational/Other
OTHERPatients 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.
Interventions
Using a spirometer, an armband, and a tablet to collect data.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (18)
Research Site
Long Beach, California, 90806, United States
Research Site
Santa Ana, California, 92705, United States
Research Site
Englewood, Colorado, 80113, United States
Research Site
Plainville, Connecticut, 06062, United States
Research Site
Boca Raton, Florida, 33486, United States
Research Site
Tallahassee, Florida, 32308, United States
Research Site
Tampa, Florida, 33612, United States
Research Site
Atlanta, Georgia, 30322, United States
Research Site
Westwood, Kansas, 66205, United States
Research Site
Louisville, Kentucky, 40241, United States
Research Site
Pontiac, Michigan, 48341, United States
Research Site
New York, New York, 10029, United States
Research Site
Cincinnati, Ohio, 45267, United States
Research Site
Massillon, Ohio, 44646, United States
Research Site
Knoxville, Tennessee, 37916, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
Lacey, Washington, 98503, United States
Research Site
Tacoma, Washington, 98405, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This pilot trial was terminated early due to the Coronavirus Disease-2019 (COVID-19) pandemic, shortage of site staff, and limited access to sites resulting in participant enrollment and retention challenges. The trial was not terminated early due to any safety concerns.
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2020
First Posted
May 8, 2020
Study Start
April 27, 2020
Primary Completion
January 27, 2022
Study Completion
January 27, 2022
Last Updated
June 22, 2023
Results First Posted
June 22, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.