RELEVANCE - RWE Study in Unresectable Non-Small Cell Lung Cancer (Stage III) in Canada

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Durvalumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Durvalumab cohort<br>All stage III non-small cell lung cancer (NSCLC) patients who received durvalumab | Drug: Durvalumab<br>* Chemoradiotherapy plus durvalumab<br>* Other names: Imfinzi;|
| Non-durvalumab cohort<br>All stage III non-small cell lung cancer (NSCLC) patients who did not receive durvalumab | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | November 1, 2017 to August 31, 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Proportion of PACIFIC regimen initiation and uptake in patients who received CRT | Uptake of durvaluamab 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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real-world evidence, treatment patterns, clinical outcomes, durvalumab, chemoradiotherapy