Clinical trial · Observational
Observational Study of Durvalumab in Patients With Non-small-cell Lung Cancer in the United Kingdom
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer NSCLC | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Overall Survival
- timeFrame
- 12 months
- description
- This study will estimate the proportion of patients known to be alive at 12 months post-index event
- measure
- Overall Survival
- timeFrame
- 24 months
- description
- This study will estimate the proportion of patients known to be alive at 24 months post-index event
Secondary outcomes (7)
- measure
- Progression Free Survival
- timeFrame
- 12 months
- description
- 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,
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available