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

Non-Small Cell Lung Cancer NSCLC Clinical Trial

— CODAK  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04667312
• Other study ID #: D4191R00038
• Status: Completed
• Start date: June 24, 2021
• Est. completion date: September 28, 2022

Study information

• Verified date: September 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: September 28, 2022
• Est. primary completion date: September 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer NSCLC

Intervention

Drug:
• Durvalumab
Durvalumab

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	This study will estimate the proportion of patients known to be alive at 12 months post-index event	12 months
Primary	Overall Survival	This study will estimate the proportion of patients known to be alive at 24 months post-index event	24 months
Secondary	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,	12 months
Secondary	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,	24 months
Secondary	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.	12 months
Secondary	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.	24 months
Secondary	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]).	Up to 24 months
Secondary	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.	Up to 24 months
Secondary	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.	Up to 24 months

External Links

•   CSR Synopsis 20Sep2023