Study identification

EU PAS number

EUPAS46367

Study ID

46368

Official title and acronym

Health Care Professional survey on understanding of key risk minimisation measures related to interstitial lung disease (ILD) / pneumonitis with Trastuzumab Deruxtecan treatment

DARWIN EU® study

No

Study countries

Austria
Denmark
France
Germany
Spain
Sweden
United Kingdom

Study description

Interstitial lung disease (ILD) and/or pneumonitis have been identified as important risks for patients treated with Trastuzumab Deruxtecan, and fatal outcomes have been observed. To prevent / minimize the occurrence of severe ILD/pneumonitis, the Marketing Authorization Holder proposed additional risk minimisation measures (aRMM) for ILD/ pneumonitis and developed educational material. A prescriber survey will be performed in the EU Member States where Trastuzumab Deruxtecan is marketed to evaluate effectiveness of the taken key risk minimisation measures for ILD/ pneumonitis. The aim of this study is to evaluate the effectiveness of Trastuzumab Deruxtecan’s risk minimisation measures for the important identified risk of ILD/pneumonitis by assessing their correct implementation among physicians expected to prescribe Trastuzumab Deruxtecan. Physicians’ knowledge and understanding of the educational material will be evaluated.

Study status

Finalised
Research institutions and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution Non-Pharmaceutical company ENCePP partner

Contact details

Birgit Ehlken

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

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

More details on funding

Daiichi Sankyo Europe GmbH
Regulatory

Was the study required by a regulatory body?

No

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

EU RMP category 3 (required)