RELEVANCE - RWE Study in Unresectable Non-Small Cell Lung Cancer (Stage III) in Canada (RELEVANCE)
August 31, 2023 updated by: AstraZeneca
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
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
662
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 1N4
- University Of Calgary
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- BC Cancer
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
- Queen Elizabeth (QE) II Health Sciences Centre
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital
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Quebec
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Montreal, Quebec, Canada, H2X 3E4
- Centre hospitalier de l'Université de Montréal (CHUM)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Durvalumab cohort
All stage III non-small cell lung cancer (NSCLC) patients who received durvalumab
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Chemoradiotherapy plus durvalumab
Other Names:
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Non-durvalumab cohort
All stage III non-small cell lung cancer (NSCLC) patients who did not receive durvalumab
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Overall survival
Time Frame: November 1, 2017 to August 31, 2022
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November 1, 2017 to August 31, 2022
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Rate and type of resection
Time Frame: November 1, 2017 to August 31, 2022
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November 1, 2017 to August 31, 2022
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Treatments received including rates of concurrent chemoradiotherapy (cCRT) and sequential chemoradiotherapy (sCRT) use in unresectable disease
Time Frame: November 1, 2017 to August 31, 2022
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November 1, 2017 to August 31, 2022
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Proportion of PACIFIC regimen initiation and uptake in patients who received CRT
Time Frame: November 1, 2017 to August 31, 2022
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Uptake of durvaluamab in patients who received CRT
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November 1, 2017 to August 31, 2022
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Reasons for treatment discontinuation
Time Frame: November 1, 2017 to August 31, 2022
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November 1, 2017 to August 31, 2022
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Time-to-treatment discontinuation
Time Frame: November 1, 2017 to August 31, 2022
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November 1, 2017 to August 31, 2022
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Time to durvalumab initiation following CRT
Time Frame: November 1, 2017 to August 31, 2022
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November 1, 2017 to August 31, 2022
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Rate and type of adverse events of special interest in the durvalumab cohort
Time Frame: November 1, 2017 to August 31, 2022
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November 1, 2017 to August 31, 2022
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 19, 2021
Primary Completion (Actual)
August 31, 2022
Study Completion (Actual)
August 31, 2022
Study Registration Dates
First Submitted
June 28, 2023
First Submitted That Met QC Criteria
June 28, 2023
First Posted (Actual)
July 6, 2023
Study Record Updates
Last Update Posted (Actual)
September 5, 2023
Last Update Submitted That Met QC Criteria
August 31, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D4191R00028
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.