Clinical trial NCT04667312: Observational Study of Durvalumab in Patients With Non-small-cell Lung Cancer in the United Kingdom
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer NSCLC
Keywords: NSCLC unresectable stage III
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2020-12-14
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: 12 months
measure: Overall Survival
timeFrame: 24 months
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 12 months
measure: Progression Free Survival
timeFrame: 24 months
measure: Second Progression Free Survival
timeFrame: 12 months
measure: Second Progression Free Survival
timeFrame: 24 months
measure: Best Overall Response
timeFrame: Up to 24 months
measure: Time to Treatment Discontinuation
timeFrame: Up to 24 months
measure: Time to first subsequent therapy
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Canterbury
country: United Kingdom
facility: East Kent Hospital
city: Cardiff
country: United Kingdom
facility: Velindre Hospital
city: Harrogate
country: United Kingdom
facility: Harrogate and district NHS foundation Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust
Study officials:
affiliation: Leeds Teaching Hospitals NHS Trust
name: Kevin Franks
role: PRINCIPAL_INVESTIGATOR
References: