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Completed

NCT Number: NCT05933044

RELEVANCE - RWE Study in 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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Durvalumab

Drug

Chemoradiotherapy plus durvalumab

Other names: Imfinzi

Primary outcomes

  1. Overall survival

    Time frame: November 1, 2017 to August 31, 2022

Secondary outcomes

  1. Rate and type of resection

    Time frame: November 1, 2017 to August 31, 2022

  2. 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

  3. Proportion of PACIFIC regimen initiation and uptake in patients who received CRT

    Time frame: November 1, 2017 to August 31, 2022

    Uptake of durvaluamab in patients who received CRT

  4. Reasons for treatment discontinuation

    Time frame: November 1, 2017 to August 31, 2022

  5. Time-to-treatment discontinuation

    Time frame: November 1, 2017 to August 31, 2022

  6. Time to durvalumab initiation following CRT

    Time frame: November 1, 2017 to August 31, 2022

  7. Rate and type of adverse events of special interest in the durvalumab cohort

    Time frame: November 1, 2017 to August 31, 2022

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: RELEVANCE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 6, 2023
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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