RELEVANCE - RWE Study in Unresectable Non-Small Cell Lung Cancer (Stage III) in Canada
- Registration Number
- NCT05933044
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 662
- 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)
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Durvalumab cohort Durvalumab All stage III non-small cell lung cancer (NSCLC) patients who received durvalumab
- Primary Outcome Measures
Name Time Method Overall survival November 1, 2017 to August 31, 2022
- Secondary Outcome Measures
Name Time Method 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 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 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
Trial Locations
- Locations (5)
Queen Elizabeth (QE) II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
University of Calgary
🇨🇦Calgary, Alberta, Canada
Centre hospitalier de l'Université de Montréal (CHUM)
🇨🇦Montreal, Quebec, Canada
BC Cancer
🇨🇦Vancouver, British Columbia, Canada