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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Unresectable Stage III NSCLC
- Sponsor
- AstraZeneca
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Number of Participants With Treatment-Emergent Adverse Event (TEAE) of Pneumonitis by Grade
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Number of Participants With Treatment-Emergent Adverse Event (TEAE) of Pneumonitis by Grade
Time Frame: 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
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.
Secondary Outcomes
- Duration of Prescription Medication Received by Participants to Manage Pneumonitis TEAEs(Up to Month 12)
- Duration of Durvalumab Treatment(Up to Month 12)
- Number of Participants With Treatment Interruptions(Up to Month 12)
- Duration of Durvalumab Treatment Interruption(Up to Month 12)
- Number of Participants Who Received Prescription Medication to Manage Pneumonitis TEAEs(Up to Month 12)
- Duration of Pulmonary TEAEs Excluding Pneumonitis(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)
- Change From Baseline in EORTC QLQ-Lung Cancer (LC)13 in Participants With Pneumonitis TEAEs(Baseline visit (Day 1), every 2 weeks for the first 3 months and once monthly thereafter, and at End-of-Study visit (Month 12))
- 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(Baseline visit (Day 1), every 2 weeks for the first 3 months and once monthly thereafter, and at End-of-Study visit (Month 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)
- Number of Participants With Early Discontinuation of Durvalumab(Up to Month 12)
- Number of Participants With Pulmonary TEAEs Excluding Pneumonitis(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 Development of Grade 3 to Grade 5 TEAEs, Including Pneumonitis(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)