Status:
TERMINATED
Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab.
Lead Sponsor:
AstraZeneca
Conditions:
Unresectable Stage III NSCLC
Eligibility:
All Genders
18-130 years
Phase:
PHASE4
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 b...
Eligibility Criteria
Inclusion
- Select
- 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
- 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.
Key Trial Info
Start Date :
April 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04381494
Start Date
April 27 2020
End Date
January 27 2022
Last Update
June 22 2023
Active Locations (18)
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1
Research Site
Long Beach, California, United States, 90806
2
Research Site
Santa Ana, California, United States, 92705
3
Research Site
Englewood, Colorado, United States, 80113
4
Research Site
Plainville, Connecticut, United States, 06062