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Non-Small Cell Lung Cancer NSCLCCODAKNCT04667312

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

An observational study of Non-Small Cell Lung Cancer NSCLC, run by AstraZeneca at 10 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer NSCLC
What is being tested?
Durvalumab
How many people
115 participants
Where
10 sitesUnited Kingdom
Study dates
24 Jun 2021to 28 Sep 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United Kingdom10 sites

  • East Kent Hospital

    Canterbury, CT1 3NG

  • Velindre Hospital

    Cardiff, CF14 2TL

  • Harrogate and district NHS foundation Trust

    Harrogate, HG2 7SX

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF

  • Guy's Hospital

    London, SE1 9RT

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • The Christie NHS Foundation

    Manchester, M20 4BX

  • Queen Alexandra Hospital

    Portsmouth, PO6 3LY

  • Musgrove Park Hospital

    Taunton, TA1 5DA

  • Royal Cornwall Hospitals NHS Trust

    Truro, TR1 3LJ

Other trials in United Kingdom

About this study

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.

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.

Read the 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
  3. To describe treatment patterns of durvalumab
Being tested
Durvalumab
Keywords
NSCLC unresectable stage III

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    This study will estimate the proportion of patients known to be alive at 12 months post-index event

    Measured: 12 months

  2. Overall Survival

    This study will estimate the proportion of patients known to be alive at 24 months post-index event

    Measured: 24 months

Secondary outcomes (7)

  1. 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,

    Measured: 12 months

  2. 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,

    Measured: 24 months

  3. 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.

    Measured: 12 months

  4. 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.

    Measured: 24 months

  5. 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]).

    Measured: Up to 24 months

  6. 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.

    Measured: Up to 24 months

  7. 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.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2020
  2. Study start24 Jun 2021
  3. Primary completion28 Sep 2022
  4. Study completion28 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04667312
Sponsor's protocol ID
D4191R00038
Acronym
CODAK
Status last verified
Sep 2023
First submitted
27 Nov 2020
Last updated
2 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Non-Small Cell Lung Cancer NSCLC, run by AstraZeneca at 10 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04667312.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.

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