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

Study Overview
=================
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: To describe clinical outcomes To describe the patient demographic and clinical characteristics Secondary Objective 1. To describe treatment patterns of durvalumab

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.

Conditions
-----------------
Non-Small Cell Lung Cancer NSCLC

Intervention / Treatment
-----------------
* Drug: Durvalumab


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Durvalumab|Durvalumab|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, | 12 months | 
| 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, | 24 months | 
| 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. | 12 months | 
| 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. | 24 months | 
| 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]). | Up to 24 months | 
| 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. | Up to 24 months | 
| 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. | Up to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC unresectable stage III