A Prospective non-interventional study (NIS) of trastuzumab deRuxtecan (T-DXd) for adult patients with advanced HER2-pOsitive gaStric or gastroesoPhageal junction (GEJ) adEnocarcinoma who have Received a prIor Trastuzumab-based regimen, accompanied by a disease registrY of patients treated with conventional therapies in a real-world setting in Europe (PROSPERITY).

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000340
• EU PAS number:
  EUPAS1000000340
• Study ID:
  1000000340
• Official title and acronym:
  A Prospective non-interventional study (NIS) of trastuzumab deRuxtecan (T-DXd) for adult patients with advanced HER2-pOsitive gaStric or gastroesoPhageal junction (GEJ) adEnocarcinoma who have Received a prIor Trastuzumab-based regimen, accompanied by a disease registrY of patients treated with conventional therapies in a real-world setting in Europe (PROSPERITY).
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Germany

  Italy

  Portugal
• Study status:
  Planned

Research institutions and networks

Institutions

Clinical, Regulatory and Safety, Cerner Enviza

Germany

Daiichi-Sankyo Europe GmbH

Germany

Study timelines

Date when funding contract was signed

Planned: 06/06/2023

Actual: 06/06/2023

Study start date

Planned: 31/03/2024

Date of final study report

Planned: 30/09/2027

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  Unknown
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable