A Retrospective Observational, Multi-Centre, Cohort Study to Understand Real-World Treatment Patterns and Clinical Outcomes of Adult Patients With Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) in Canada

AstraZeneca5 sites in 1 country662 target enrollmentNovember 19, 2021

ConditionsNon-small Cell Lung Cancer

InterventionsDurvalumab

DrugsDurvalumab

Overview

Phase: Not Applicable
Intervention: Durvalumab
Conditions: Non-small Cell Lung Cancer
Sponsor: AstraZeneca
Enrollment: 662
Locations: 5
Primary Endpoint: Overall survival
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 19, 2021

End Date

August 31, 2022

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Durvalumab cohort

All stage III non-small cell lung cancer (NSCLC) patients who received durvalumab

Intervention: Durvalumab

Outcomes

Primary Outcomes

Overall survival

Time Frame: November 1, 2017 to August 31, 2022

Secondary Outcomes

Proportion of PACIFIC regimen initiation and uptake in patients who received CRT(November 1, 2017 to August 31, 2022)
Reasons for treatment discontinuation(November 1, 2017 to August 31, 2022)
Time-to-treatment discontinuation(November 1, 2017 to August 31, 2022)
Rate and type of resection(November 1, 2017 to August 31, 2022)
Treatments received including rates of concurrent chemoradiotherapy (cCRT) and sequential chemoradiotherapy (sCRT) use in unresectable disease(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)