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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.
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 treatment patterns of durvalumab
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | Durvalumab |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population is adult patients with locally advanced, unresectable Stage III NSCLC treated with durvalumab following platinum based chemoradiotherapy.
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Franks | Leeds Teaching Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Kent Hospital | Canterbury | CT1 3NG | United Kingdom | |||
| Velindre Hospital |
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| Label | URL |
|---|---|
| CSR Synopsis 20Sep2023 | View source |
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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.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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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 |
| Cardiff |
| CF14 2TL |
| United Kingdom |
| Harrogate and district NHS foundation Trust | Harrogate | HG2 7SX | United Kingdom |
| Leeds Teaching Hospitals NHS Trust | Leeds | LS9 7TF | United Kingdom |
| Guy's Hospital | London | SE1 9RT | United Kingdom |
| The Royal Marsden NHS Foundation Trust | London | SW3 6JJ | United Kingdom |
| The Christie NHS Foundation | Manchester | M20 4BX | United Kingdom |
| Queen Alexandra Hospital | Portsmouth | PO6 3LY | United Kingdom |
| Musgrove Park Hospital | Taunton | TA1 5DA | United Kingdom |
| Royal Cornwall Hospitals NHS Trust | Truro | TR1 3LJ | United Kingdom |
| ID | Term |
|---|---|
| C000613593 | durvalumab |
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