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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-24

Study Completion Date

2022-09-28

Brief Summary

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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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Detailed Description

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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

Conditions

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Non-Small Cell Lung Cancer NSCLC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Durvalumab

Intervention Type DRUG

Other Intervention Names

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Imfinzi

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No