Back to resultsMobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab. (ON TRAX)
Primary Purpose
Unresectable Stage III NSCLC
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Multiparametric Mobile Technology
Sponsored by
About this trial
This is an interventional other trial for Unresectable Stage III NSCLC focused on measuring 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
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.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Observational/Other
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants With Permanent Discontinuation of Durvalumab Due to Pulmonary TEAEs
Pulmonary TEAEs were defined as any pulmonary AEs 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. Number of participants with permanent discontinuation of durvalumab due to pulmonary TEAEs including pneumonitis are reported.
Duration of Durvalumab Treatment
The overall duration of durvalumab treatment, while participants were a part of this wearable study, was calculated as end date of durvalumab treatment minus first dose of durvalumab (Day 1) plus 1.
Number of Participants With Early Discontinuation of Durvalumab
Number of participants who discontinued durvalumab early due to any reason are reported.
Number of Participants With Treatment Interruptions
Treatment interruptions were defined as at least 1 temporary withholding of durvalumab treatment. Treatment withheld was defined as temporarily withheld of durvalumab recorded in case report form. Short interruptions defined as the durvalumab infusion interruption during the administration recorded in CRF in a single visit were excluded from the analysis. Due to data issue, the reason for treatment withheld was not captured in the database.
Duration of Durvalumab Treatment Interruption
The overall duration of durvalumab treatment interruption was calculated as the sum of the duration of each treatment withheld/resumed. The duration of interruption included only treatment withheld. Short interruption which resumed during the same visit was not included in the calculation for duration of interruption.
Number of Participants With Pulmonary TEAEs Excluding Pneumonitis
Pulmonary TEAEs were defined as any pulmonary AEs 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.
Duration of Pulmonary TEAEs Excluding Pneumonitis
Pulmonary TEAEs were defined as any pulmonary AEs 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. Duration of pulmonary TEAEs was calculated as end date of pulmonary TEAE minus onset date of pulmonary TEAE plus 1. For AEs that were missing an end date, the data cut-off date was used as the AE end date for calculation of AE duration.
Number of Participants Who Received Prescription Medication to Manage Pneumonitis TEAEs
Pneumonitis TEAEs were defined as any pneumonitis AEs 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.
Duration of Prescription Medication Received by Participants to Manage Pneumonitis TEAEs
Pneumonitis TEAEs were defined as any pneumonitis AEs 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.
Duration of Development of Grade 3 to Grade 5 TEAEs, Including Pneumonitis
Duration of development of Grade 3 to 5 pneumonitis AEs is defined as the period from Day 1 to earliest of each grade of pneumonitis AE (grade 3, grade 4, and grade 5). Severity (intensity of an event) was assessed using the NCI-CTCAE v5. 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.
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
The EORTC QLQ-C30 consisted of 30 questions and included functional scales (FS) (items 1-7 and items 20-27), symptom scales (items 8-19 and item 28) and global measure of health status (GHS) (items 29-30). The scale ranged from 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much". Scores were averaged and transformed to 0 to 100, a high score for functional scales/GHS represented better functioning ability/QoL, whereas a high score for symptom scales represented stronger symptoms/worse QoL. Participants with pneumonitis TEAEs with causal relationship with durvalumab are presented. Time point 1: prior to occurrence of initial pneumonitis AE; Time point 2: at same time point as initial pneumonitis AE; Time point 3: when highest CTCAE grade of pneumonitis AE occurred. Baseline was defined as the date of informed consent for this parameter.
Change From Baseline in EORTC QLQ-Lung Cancer (LC)13 in Participants With Pneumonitis TEAEs
The EORTC QLQ-LC13 was a disease-specific 13-item questionnaire for lung cancer used in conjunction with the EORTC QLQ-C30. It comprised both multi-item and single-item measures of lung cancer associated symptoms (LCAS) (items 31-35 and items 40-42), treatment related side effects (TREF) (items 36-39) and pain medication (item 43). The scale ranged from 1-4 for most outcome measures of systems, 1 rated as "not at all" and 4 rated as "very much". Scores were averaged and transformed to 0 to 100, higher scores for LCAS and TREF: greater level of symptoms/worse QoL and higher scores for pain medication: better pain relief from medication. Participants with pneumonitis TEAEs with causal relationship with durvalumab are presented. Time point 1: prior to occurrence of initial pneumonitis AE; Time point 2: at same time point as initial pneumonitis AE; Time point 3: when highest CTCAE grade of pneumonitis AE occurred. Baseline was defined as the date of informed consent for this parameter.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04381494
Brief Title
Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab.
Acronym
ON TRAX
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why 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
Study Start Date
April 27, 2020 (Actual)
Primary Completion Date
January 27, 2022 (Actual)
Study Completion Date
January 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Observational/Other
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Multiparametric Mobile Technology
Intervention Description
Using a spirometer, an armband, and a tablet to collect data.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Event (TEAE) of Pneumonitis by Grade
Description
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.
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
Secondary Outcome Measure Information:
Title
Number of Participants With Permanent Discontinuation of Durvalumab Due to Pulmonary TEAEs
Description
Pulmonary TEAEs were defined as any pulmonary AEs 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. Number of participants with permanent discontinuation of durvalumab due to pulmonary TEAEs including pneumonitis are reported.
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
Title
Duration of Durvalumab Treatment
Description
The overall duration of durvalumab treatment, while participants were a part of this wearable study, was calculated as end date of durvalumab treatment minus first dose of durvalumab (Day 1) plus 1.
Time Frame
Up to Month 12
Title
Number of Participants With Early Discontinuation of Durvalumab
Description
Number of participants who discontinued durvalumab early due to any reason are reported.
Time Frame
Up to Month 12
Title
Number of Participants With Treatment Interruptions
Description
Treatment interruptions were defined as at least 1 temporary withholding of durvalumab treatment. Treatment withheld was defined as temporarily withheld of durvalumab recorded in case report form. Short interruptions defined as the durvalumab infusion interruption during the administration recorded in CRF in a single visit were excluded from the analysis. Due to data issue, the reason for treatment withheld was not captured in the database.
Time Frame
Up to Month 12
Title
Duration of Durvalumab Treatment Interruption
Description
The overall duration of durvalumab treatment interruption was calculated as the sum of the duration of each treatment withheld/resumed. The duration of interruption included only treatment withheld. Short interruption which resumed during the same visit was not included in the calculation for duration of interruption.
Time Frame
Up to Month 12
Title
Number of Participants With Pulmonary TEAEs Excluding Pneumonitis
Description
Pulmonary TEAEs were defined as any pulmonary AEs 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.
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
Title
Duration of Pulmonary TEAEs Excluding Pneumonitis
Description
Pulmonary TEAEs were defined as any pulmonary AEs 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. Duration of pulmonary TEAEs was calculated as end date of pulmonary TEAE minus onset date of pulmonary TEAE plus 1. For AEs that were missing an end date, the data cut-off date was used as the AE end date for calculation of AE duration.
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
Title
Number of Participants Who Received Prescription Medication to Manage Pneumonitis TEAEs
Description
Pneumonitis TEAEs were defined as any pneumonitis AEs 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.
Time Frame
Up to Month 12
Title
Duration of Prescription Medication Received by Participants to Manage Pneumonitis TEAEs
Description
Pneumonitis TEAEs were defined as any pneumonitis AEs 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.
Time Frame
Up to Month 12
Title
Duration of Development of Grade 3 to Grade 5 TEAEs, Including Pneumonitis
Description
Duration of development of Grade 3 to 5 pneumonitis AEs is defined as the period from Day 1 to earliest of each grade of pneumonitis AE (grade 3, grade 4, and grade 5). Severity (intensity of an event) was assessed using the NCI-CTCAE v5. 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.
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
Title
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
Description
The EORTC QLQ-C30 consisted of 30 questions and included functional scales (FS) (items 1-7 and items 20-27), symptom scales (items 8-19 and item 28) and global measure of health status (GHS) (items 29-30). The scale ranged from 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much". Scores were averaged and transformed to 0 to 100, a high score for functional scales/GHS represented better functioning ability/QoL, whereas a high score for symptom scales represented stronger symptoms/worse QoL. Participants with pneumonitis TEAEs with causal relationship with durvalumab are presented. Time point 1: prior to occurrence of initial pneumonitis AE; Time point 2: at same time point as initial pneumonitis AE; Time point 3: when highest CTCAE grade of pneumonitis AE occurred. Baseline was defined as the date of informed consent for this parameter.
Time Frame
Baseline visit (Day 1), every 2 weeks for the first 3 months and once monthly thereafter, and at End-of-Study visit (Month 12)
Title
Change From Baseline in EORTC QLQ-Lung Cancer (LC)13 in Participants With Pneumonitis TEAEs
Description
The EORTC QLQ-LC13 was a disease-specific 13-item questionnaire for lung cancer used in conjunction with the EORTC QLQ-C30. It comprised both multi-item and single-item measures of lung cancer associated symptoms (LCAS) (items 31-35 and items 40-42), treatment related side effects (TREF) (items 36-39) and pain medication (item 43). The scale ranged from 1-4 for most outcome measures of systems, 1 rated as "not at all" and 4 rated as "very much". Scores were averaged and transformed to 0 to 100, higher scores for LCAS and TREF: greater level of symptoms/worse QoL and higher scores for pain medication: better pain relief from medication. Participants with pneumonitis TEAEs with causal relationship with durvalumab are presented. Time point 1: prior to occurrence of initial pneumonitis AE; Time point 2: at same time point as initial pneumonitis AE; Time point 3: when highest CTCAE grade of pneumonitis AE occurred. Baseline was defined as the date of informed consent for this parameter.
Time Frame
Baseline visit (Day 1), every 2 weeks for the first 3 months and once monthly thereafter, and at End-of-Study visit (Month 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Research Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Research Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Research Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Research Site
City
Plainville
State/Province
Connecticut
ZIP/Postal Code
06062
Country
United States
Facility Name
Research Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Research Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Research Site
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Research Site
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Research Site
City
Massillon
State/Province
Ohio
ZIP/Postal Code
44646
Country
United States
Facility Name
Research Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States
Facility Name
Research Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Links:
URL
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Related Info
URL
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Related Info
URL
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Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab.
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