Clinical trial NCT05933044: RELEVANCE - RWE Study in Unresectable Non-Small Cell Lung Cancer (Stage III) in Canada
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Keywords: real-world evidence, treatment patterns, clinical outcomes, durvalumab, chemoradiotherapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-07-06
Enrollment: 662
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with stage III NSCLC who received treatment at one of the participating clinical centres across Canada from November 1, 2017 until December 31, 2019

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.


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

Primary outcomes:
measure: Overall survival
timeFrame: November 1, 2017 to August 31, 2022
Secondary outcomes:
measure: Rate and type of resection
timeFrame: November 1, 2017 to August 31, 2022
measure: Treatments received including rates of concurrent chemoradiotherapy (cCRT) and sequential chemoradiotherapy (sCRT) use in unresectable disease
timeFrame: November 1, 2017 to August 31, 2022
measure: Proportion of PACIFIC regimen initiation and uptake in patients who received CRT
timeFrame: November 1, 2017 to August 31, 2022
measure: Reasons for treatment discontinuation
timeFrame: November 1, 2017 to August 31, 2022
measure: Time-to-treatment discontinuation
timeFrame: November 1, 2017 to August 31, 2022
measure: Time to durvalumab initiation following CRT
timeFrame: November 1, 2017 to August 31, 2022
measure: Rate and type of adverse events of special interest in the durvalumab cohort
timeFrame: November 1, 2017 to August 31, 2022
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: BC Cancer
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth (QE) II Health Sciences Centre
state: Nova Scotia
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
References: