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.
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
Study Type
OBSERVATIONAL
Enrollment
115
Durvalumab
East Kent Hospital
Canterbury, United Kingdom
Velindre Hospital
Cardiff, United Kingdom
Harrogate and district NHS foundation Trust
Harrogate, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Guy's Hospital
London, United Kingdom
The Royal Marsden NHS Foundation Trust
London, United Kingdom
The Christie NHS Foundation
Manchester, United Kingdom
Queen Alexandra Hospital
Portsmouth, United Kingdom
Musgrove Park Hospital
Taunton, United Kingdom
Royal Cornwall Hospitals NHS Trust
Truro, United Kingdom
Overall Survival
This study will estimate the proportion of patients known to be alive at 12 months post-index event
Time frame: 12 months
Overall Survival
This study will estimate the proportion of patients known to be alive at 24 months post-index event
Time frame: 24 months
Progression Free Survival
In this study, rwPFS will describe the proportion of patients known to be alive and free from disease progression at 12 months post-index event,
Time frame: 12 months
Progression Free Survival
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,
Time frame: 24 months
Second Progression Free Survival
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 12 months post-durvalumab initiation.
Time frame: 12 months
Second Progression Free Survival
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.
Time frame: 24 months
Best Overall Response
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 \[NR\]).
Time frame: Up to 24 months
Time to Treatment Discontinuation
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.
Time frame: Up to 24 months
Time to first subsequent therapy
Time to initiation of first subsequent therapy will be summarized using the Kaplan-Meier method, including the presentation of Kaplan-Meier plots.
Time frame: Up to 24 months
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