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

NCT05933044 | Completed

• 1 other identifier: D4191R00028
• Study Type: observational
• Target: 662
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Non-small Cell Lung Cancer

Keywords

real-world evidence, treatment patterns, clinical outcomes, durvalumab, chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  November 1, 2017 to August 31, 2022

Secondary Outcomes (7)

• 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

  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

Study Arms (2)

Durvalumab cohort

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

Drug: Durvalumab

Non-durvalumab cohort

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

Interventions

Durvalumab DRUG

Chemoradiotherapy plus durvalumab

Also known as: Imfinzi

Durvalumab cohort

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (5)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

BC Cancer

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Queen Elizabeth (QE) II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

Related Links

• Redacted CSR synopsis

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 6, 2023
• Study Start: November 19, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: September 5, 2023

Record last verified: 2023-08

Locations

CA (5)