Non-small Cell Lung Cancer
Conditions
Keywords
real-world evidence, treatment patterns, clinical outcomes, durvalumab, chemoradiotherapy
Brief summary
In the RELEVANCE study, we will develop a scalable electronic medical report data capture platform to collect and analyse real-world data in the stage III NSCLC population in Canada across several Canadian cancer centres. Subsequent analyses will examine treatment patterns and clinical outcomes, including overall survival, for these patients, stratified by durvalumab regimen or non-durvalumab regimen during the time of the PACIFIC Patient Support Program.
Interventions
DRUGDurvalumab
Chemoradiotherapy plus durvalumab
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18 years or older * Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent (stage III) disease between November 1, 2017 and December 31, 2019 at the centre (Note: durvalumab uptake rate requires a secondary index date, such as initiation of CRT before availability of durvalumab in May 2018)
Exclusion criteria
* Patients treated with durvalumab in clinical studies prior to the start date * Clinical trial patients where treatments received are blinded in the patient medical records
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | November 1, 2017 to August 31, 2022 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatments received including rates of concurrent chemoradiotherapy (cCRT) and sequential chemoradiotherapy (sCRT) use in unresectable disease | November 1, 2017 to August 31, 2022 | — |
| Proportion of PACIFIC regimen initiation and uptake in patients who received CRT | November 1, 2017 to August 31, 2022 | Uptake of durvaluamab in patients who received CRT |
| Reasons for treatment discontinuation | November 1, 2017 to August 31, 2022 | — |
| Rate and type of resection | November 1, 2017 to August 31, 2022 | — |
| Time to durvalumab initiation following CRT | November 1, 2017 to August 31, 2022 | — |
| Rate and type of adverse events of special interest in the durvalumab cohort | November 1, 2017 to August 31, 2022 | — |
| Time-to-treatment discontinuation | November 1, 2017 to August 31, 2022 | — |
Countries
Canada
Outcome results
None listed