Adults 18 to 130, any sex, with Unresectable Stage III NSCLC. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-Emergent Adverse Event (TEAE) of Pneumonitis by GradePrimary· 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) Co
Grade 2
Group
Value
95% CI
All Participants
2
Grade 3
Group
Value
95% CI
All Participants
1
Number of Participants With Permanent Discontinuation of Durvalumab Due to Pulmonary TEAEsSecondary· 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
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.
Group
Value
95% CI
All Participants
0
Duration of Durvalumab TreatmentSecondary· Up to Month 12
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.
Group
Value
95% CI
All Participants
107.5
1 – 352
Number of Participants With Early Discontinuation of DurvalumabSecondary· Up to Month 12
Number of participants who discontinued durvalumab early due to any reason are reported.
Group
Value
95% CI
All Participants
3
Number of Participants With Treatment InterruptionsSecondary· Up to Month 12
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.
Group
Value
95% CI
All Participants
9
Duration of Durvalumab Treatment InterruptionSecondary· Up to Month 12
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.
Group
Value
95% CI
All Participants
50.8
± 50.79
Number of Participants With Pulmonary TEAEs Excluding PneumonitisSecondary· 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
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.
Group
Value
95% CI
All Participants
19
Duration of Pulmonary TEAEs Excluding PneumonitisSecondary· 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
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.
Group
Value
95% CI
All Participants
153.4
± 156.26
Number of Participants Who Received Prescription Medication to Manage Pneumonitis TEAEsSecondary· Up to Month 12
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.
Group
Value
95% CI
All Participants
2
Duration of Prescription Medication Received by Participants to Manage Pneumonitis TEAEsSecondary· Up to Month 12
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.
Group
Value
95% CI
All Participants
17.5
± 3.54
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 TEAEsSecondary· Baseline visit (Day 1), every 2 weeks for the first 3 months and once monthly thereafter, and at End-of-Study visit (Month 12)
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 relationshi
FS; Time point 1
Group
Value
95% CI
All Participants
5.56
± 4.714
FS; Time point 2
Group
Value
95% CI
All Participants
2.22
± NA
FS; Time point 3
Group
Value
95% CI
All Participants
2.22
± NA
Symptom scale; Time point 1
Group
Value
95% CI
All Participants
-10.26
± 3.626
Symptom scale; Time point 2
Group
Value
95% CI
All Participants
-7.69
± NA
Symptom scale; Time point 3
Group
Value
95% CI
All Participants
-7.69
± NA
GHS; Time point 1
Group
Value
95% CI
All Participants
4.17
± 5.893
GHS; Time point 2
Group
Value
95% CI
All Participants
8.33
± NA
Change From Baseline in EORTC QLQ-Lung Cancer (LC)13 in Participants With Pneumonitis TEAEsSecondary· Baseline visit (Day 1), every 2 weeks for the first 3 months and once monthly thereafter, and at End-of-Study visit (Month 12)
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 medi
LCAS; Time point 1
Group
Value
95% CI
All Participants
-4.17
± NA
TREF; Time point 1
Group
Value
95% CI
All Participants
-8.33
± NA
Pain medication; Time point 1
Group
Value
95% CI
All Participants
0
± NA
Adverse events — posted to ClinicalTrials.gov
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.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 22 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04381494.