Ignite Creation Date:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
Study NCT ID:
NCT04667312
Status:
COMPLETED
Last Update Posted:
2023-10-02
First Post:
2020-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study of Durvalumab in Patients With Non-small-cell Lung Cancer in the United Kingdom
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
CODAK: 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 UK.
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CODAK
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: