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.
1 other identifier
observational
115
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2020
CompletedFirst Posted
Study publicly available on registry
December 14, 2020
CompletedStudy Start
First participant enrolled
June 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2022
CompletedOctober 2, 2023
September 1, 2023
1.3 years
November 27, 2020
September 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
Progression Free Survival
12 months
Progression Free Survival
24 months
Second Progression Free Survival
12 months
Second Progression Free Survival
24 months
Best Overall Response
Up to 24 months
- +2 more secondary outcomes
Interventions
Eligibility Criteria
The study population is adult patients with locally advanced, unresectable Stage III NSCLC treated with durvalumab following platinum based chemoradiotherapy.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (10)
East Kent Hospital
Canterbury, CT1 3NG, United Kingdom
Velindre Hospital
Cardiff, CF14 2TL, United Kingdom
Harrogate and district NHS foundation Trust
Harrogate, HG2 7SX, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
The Christie NHS Foundation
Manchester, M20 4BX, United Kingdom
Queen Alexandra Hospital
Portsmouth, PO6 3LY, United Kingdom
Musgrove Park Hospital
Taunton, TA1 5DA, United Kingdom
Royal Cornwall Hospitals NHS Trust
Truro, TR1 3LJ, United Kingdom
Related Links
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Franks
Leeds Teaching Hospitals NHS Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2020
First Posted
December 14, 2020
Study Start
June 24, 2021
Primary Completion
September 28, 2022
Study Completion
September 28, 2022
Last Updated
October 2, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
- 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.
- 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.
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.