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

NCT ID: NCT05933044

Last Updated: 2023-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

662 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-19

Study Completion Date

2022-08-31

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.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Durvalumab cohort

All stage III non-small cell lung cancer (NSCLC) patients who received durvalumab

Durvalumab

Intervention Type DRUG

Chemoradiotherapy plus durvalumab

Non-durvalumab cohort

All stage III non-small cell lung cancer (NSCLC) patients who did not receive durvalumab

No interventions assigned to this group

Interventions

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Durvalumab

Chemoradiotherapy plus durvalumab

Intervention Type DRUG

Other Intervention Names

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Imfinzi

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status

BC Cancer

Vancouver, British Columbia, Canada

Site Status

Queen Elizabeth (QE) II Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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D4191R00028

Identifier Type: -

Identifier Source: org_study_id

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