Observational Study of Durvalumab in Patients With Non-small-cell Lung Cancer in the United Kingdom
- Conditions
- Non-Small Cell Lung Cancer NSCLC
- Registration Number
- NCT04667312
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a retrospective observational research study to describe the characteristics and real-world clinical outcomes of patients with locally advanced, unresectable Stage III non-small cell lung cancer receiving durvalumab in the United Kingdom (the CODAK study). Physicians who have treated patients who have locally advanced, unresectable Stage III NSCLC with durvalumab will be requested to recruit patients to have their clinical data abstracted from their clinical records in line with local laws. Data from this study will provide UK-specific real-world data on patients receiving durvalumab through the Early Access Programme (EAP) or post-reimbursement.
- Detailed Description
Primary Objectives
The primary study objectives, in patients with locally advanced, unresectable Stage III NSCLC treated with durvalumab as part of the UK EAP or non-EAP, are:
1. To describe clinical outcomes
2. To describe the patient demographic and clinical characteristics Secondary Objective
1. To describe treatment patterns of durvalumab
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
- Patient has documented diagnosis of locally advanced, unresectable Stage III NSCLC
- Patient has received platinum-based CRT and received ≥1 dose of durvalumab
- Patient was initiated on durvalumab (index event) between 1st September 2017 and 31st December 2019 via the EAP or non-EAP
- Patient was aged ≥18 years at durvalumab initiation
- Patients who participated in the PACIFIC-R study
- Participation in any clinical study with an investigational product at the time of durvalumab initiation or during the observational period
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival 24 months This study will estimate the proportion of patients known to be alive at 24 months post-index event
- Secondary Outcome Measures
Name Time Method Time to first subsequent therapy Up to 24 months Time to initiation of first subsequent therapy will be summarized using the Kaplan-Meier method, including the presentation of Kaplan-Meier plots.
Time to Treatment Discontinuation Up to 24 months Time from date of durvalumab initiation to date of discontinuation will be summarized using the Kaplan-Meier method, including the presentation of Kaplan-Meier plots.
Progression Free Survival 24 months In this study, rwPFS will describe the proportion of patients known to be alive and free from disease progression at 24 months post-index event,
Second Progression Free Survival 24 months In this analysis, rwPFS2 describes the proportion of patients who progressed on durvalumab and who were known to be alive and had not progressed (including metastatic disease) on subsequent treatment at 24 months post-durvalumab initiation.
Best Overall Response Up to 24 months Best overall response, as recorded in medical records, will be described as complete response \[CR\], partial response \[PR\], stable disease \[STD\], absence of progression, progressive disease \[PD\], death, not recorded \[NR\]).
Trial Locations
- Locations (10)
East Kent Hospital
🇬🇧Canterbury, United Kingdom
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
Velindre Hospital
🇬🇧Cardiff, United Kingdom
Harrogate and district NHS foundation Trust
🇬🇧Harrogate, United Kingdom
The Royal Marsden NHS Foundation Trust
🇬🇧London, United Kingdom
Musgrove Park Hospital
🇬🇧Taunton, United Kingdom
The Christie NHS Foundation
🇬🇧Manchester, United Kingdom
Queen Alexandra Hospital
🇬🇧Portsmouth, United Kingdom
Royal Cornwall Hospitals NHS Trust
🇬🇧Truro, United Kingdom
Guy's Hospital
🇬🇧London, United Kingdom