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

AstraZeneca

Status: Completed

Conditions: Non-Small Cell Lung Cancer NSCLC

Treatments: Drug: Durvalumab

Study type: Observational

Funder types: Industry

Identifiers

NCT04667312

D4191R00038

Details and patient eligibility

About

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.

Full 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

3. To describe treatment patterns of durvalumab

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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