Non-small Cell Lung CancerRELEVANCENCT05933044
RELEVANCE - RWE Study in Unresectable Non-Small Cell Lung Cancer (Stage III) in Canada
An observational study of Non-small Cell Lung Cancer, run by AstraZeneca at 5 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Durvalumab
- How many people
- 662 participants
- Where
- 5 sitesCanada
- Study dates
- 19 Nov 2021to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
University of Calgary
Calgary, Alberta, T2N 1N4
Queen Elizabeth (QE) II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
BC Cancer
Vancouver, British Columbia, V5Z 4E6
About this study
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
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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Durvalumab
- Keywords
- real-world evidence, treatment patterns, clinical outcomes, durvalumab, chemoradiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called Imfinzi
Chemoradiotherapy plus durvalumab
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab cohort | All stage III non-small cell lung cancer (NSCLC) patients who received durvalumab Receives: Drug: Durvalumab | |
| Non-durvalumab cohort | All stage III non-small cell lung cancer (NSCLC) patients who did not receive durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: November 1, 2017 to August 31, 2022
Secondary outcomes (7)
Rate and type of resection
Measured: November 1, 2017 to August 31, 2022
Treatments received including rates of concurrent chemoradiotherapy (cCRT) and sequential chemoradiotherapy (sCRT) use in unresectable disease
Measured: 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
Measured: November 1, 2017 to August 31, 2022
Reasons for treatment discontinuation
Measured: November 1, 2017 to August 31, 2022
Time-to-treatment discontinuation
Measured: November 1, 2017 to August 31, 2022
Time to durvalumab initiation following CRT
Measured: November 1, 2017 to August 31, 2022
Rate and type of adverse events of special interest in the durvalumab cohort
Measured: November 1, 2017 to August 31, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start19 Nov 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 662 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933044
- Sponsor's protocol ID
- D4191R00028
- Acronym
- RELEVANCE
- Status last verified
- Aug 2023
- First submitted
- 28 Jun 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05933044
- Acronym / sponsor ID
- RELEVANCE / D4191R00028
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- real-world evidence, treatment patterns, clinical outcomes, durvalumab, chemoradiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 662 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Durvalumab cohort | – | Drug: DurvalumabAll stage III non-small cell lung cancer (NSCLC) patients who received durvalumab |
| Non-durvalumab cohort | – | –All stage III non-small cell lung cancer (NSCLC) patients who did not receive durvalumab |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: ImfinziChemoradiotherapy plus durvalumab | Drug | Durvalumab cohort |
Primary outcome
Overall survival
Time frame: November 1, 2017 to August 31, 2022
7 secondary outcomes
Rate and type of resection
Time frame: November 1, 2017 to August 31, 2022
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
Proportion of PACIFIC regimen initiation and uptake in patients who received CRT
Time frame: November 1, 2017 to August 31, 2022
Reasons for treatment discontinuation
Time frame: November 1, 2017 to August 31, 2022
Time-to-treatment discontinuation
Time frame: November 1, 2017 to August 31, 2022
Time to durvalumab initiation following CRT
Time frame: November 1, 2017 to August 31, 2022
Rate and type of adverse events of special interest in the durvalumab cohort
Time frame: November 1, 2017 to August 31, 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Redacted CSR synopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by AstraZeneca at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: November 1, 2017 to August 31, 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.