Study identification

PURI

https://redirect.ema.europa.eu/resource/50172

EU PAS number

EUPAS40607

Study ID

50172

Official title and acronym

Patient characteristics and treatment of non-small cell lung cancer (NSCLC) patients – a Danish nationwide registry study (20200328)

DARWIN EU® study

No

Study countries

Denmark

Study description

Retrospective cohort study of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients in a Danish nationwide cohort. The study will assess patient characteristics and treatment of patients with NSCLC. The source population is record-linkage data between the Danish Lung Cancer Register (DLCR), the Danish National Patient Registers (DNPR), the Danish Pathology Register (DPR), the Danish Civil Registration System, the Danish Prescription Registry, the National Laboratory Database Register, the National Health Insurance Service Register, the Danish education registers and the Income Statistics Register. Patients aged 18 and over at the time of NSCLC diagnosis, who were diagnosed with incident locally advanced or metastatic NSCLC between 1 Jan 18 - 30 Jun 20 will be included. Data on patients will be collected starting from date of locally advanced or metastatic NSCLC diagnosis until date of emigration, death or end of the study period (31 Dec 20), whichever occurs first.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Study protocol
Initial protocol

01.02.06 Public Redacted Protocol Ver 1.0 English (3)

English (1.96 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable