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

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.

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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer NSCLC
• Intervention / Treatment: Drug: Durvalumab

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

• Study Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• United Kingdom
  • Canterbury, United Kingdom, CT1 3NG
    • East Kent Hospital
  • Cardiff, United Kingdom, CF14 2TL
    • Velindre Hospital
  • Harrogate, United Kingdom, HG2 7SX
    • Harrogate and District NHS Foundation Trust
  • Leeds, United Kingdom, LS9 7TF
    • Leeds Teaching Hospitals NHS Trust
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation
  • Portsmouth, United Kingdom, PO6 3LY
    • Queen Alexandra Hospital
  • Taunton, United Kingdom, TA1 5DA
    • Musgrove Park Hospital
  • Truro, United Kingdom, TR1 3LJ
    • Royal Cornwall Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population is adult patients with locally advanced, unresectable Stage III NSCLC treated with durvalumab following platinum based chemoradiotherapy.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	This study will estimate the proportion of patients known to be alive at 12 months post-index event	12 months
Overall Survival	This study will estimate the proportion of patients known to be alive at 24 months post-index event	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Kevin Franks, Leeds Teaching Hospitals NHS Trust

Publications and helpful links

Helpful Links

• CSR Synopsis 20Sep2023

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2021
• Primary Completion (Actual): September 28, 2022
• Study Completion (Actual): September 28, 2022

Study Registration Dates

• First Submitted: November 27, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: NSCLC unresectable stage III
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Antineoplastic Agents, Immunological; Durvalumab
• Other Study ID Numbers: D4191R00038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No