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

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

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Durvalumab

• Study Type: Observational
• Enrollment (Actual): 662

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • University of Calgary
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • BC Cancer
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Queen Elizabeth (QE) II Health Sciences Centre
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Centre Hospitalier de l'Universite de Montreal (CHUM)

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Durvalumab cohort; All stage III non-small cell lung cancer (NSCLC) patients who received durvalumab	Drug: Durvalumab; Chemoradiotherapy plus durvalumab; Other Names: Imfinzi
Non-durvalumab cohort; All stage III non-small cell lung cancer (NSCLC) patients who did not receive durvalumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• Redacted CSR synopsis

Study record dates

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

• Keywords: real-world evidence, treatment patterns, clinical outcomes, durvalumab, chemoradiotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Antineoplastic Agents, Immunological; Durvalumab
• Other Study ID Numbers: D4191R00028