NCT04667312

Observational Study of Durvalumab in Patients With Non-small-cell Lung Cancer in the United Kingdom

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
• Phase: —
• Study type: Observational
• Enrollment: 115 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Non-Small Cell Lung Cancer NSCLC

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab

Timeline

• Start date: 2021-06-24
• Primary completion: 2022-09-28
• Completion: 2022-09-28
• First posted: 2020-12-14
• Last updated: 2023-10-02

Locations

10 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study