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

Non-small Cell Lung Cancer Clinical Trial

— RELEVANCE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05933044
• Other study ID #: D4191R00028
• Status: Completed
• Start date: November 19, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 662
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Durvalumab
Chemoradiotherapy plus durvalumab

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Queen Elizabeth (QE) II Health Sciences Centre	Halifax	Nova Scotia
Canada	Centre hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	BC Cancer	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		November 1, 2017 to August 31, 2022
Secondary	Rate and type of resection		November 1, 2017 to August 31, 2022
Secondary	Treatments received including rates of concurrent chemoradiotherapy (cCRT) and sequential chemoradiotherapy (sCRT) use in unresectable disease		November 1, 2017 to August 31, 2022
Secondary	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
Secondary	Reasons for treatment discontinuation		November 1, 2017 to August 31, 2022
Secondary	Time-to-treatment discontinuation		November 1, 2017 to August 31, 2022
Secondary	Time to durvalumab initiation following CRT		November 1, 2017 to August 31, 2022
Secondary	Rate and type of adverse events of special interest in the durvalumab cohort		November 1, 2017 to August 31, 2022

External Links

•   Redacted CSR synopsis