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Completed

NCT Number: NCT04667312

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

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.

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Key information

Conditions

Non-Small Cell Lung Cancer NSCLC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

East Kent Hospital, Canterbury, United Kingdom

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About this study

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:

  • To describe clinical outcomes
  • To describe the patient demographic and clinical characteristics Secondary Objective
  • To describe treatment patterns of durvalumab

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Durvalumab

Drug

Durvalumab

Other names: Imfinzi

Primary outcomes

  1. Overall Survival

    Time frame: 12 months

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

  2. Overall Survival

    Time frame: 24 months

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

Secondary outcomes

  1. Progression Free Survival

    Time frame: 12 months

    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,

  2. Progression Free Survival

    Time frame: 24 months

    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,

  3. Second Progression Free Survival

    Time frame: 12 months

    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.

  4. Second Progression Free Survival

    Time frame: 24 months

    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.

  5. Best Overall Response

    Time frame: Up to 24 months

    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]).

  6. Time to Treatment Discontinuation

    Time frame: Up to 24 months

    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.

  7. Time to first subsequent therapy

    Time frame: Up to 24 months

    Time to initiation of first subsequent therapy will be summarized using the Kaplan-Meier method, including the presentation of Kaplan-Meier plots.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Acronym: CODAK

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 14, 2020
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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