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Evaluating Trastuzumab Deruxtecan for Advanced HER2-positive Gastric Cancer

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)

Daiichi Sankyo · NCT05993234

This study is testing how well Trastuzumab deruxtecan works for people with advanced HER2-positive gastric cancer who have already tried other treatments.

Quick facts

Study typeObservational
Enrollment257 (estimated)
Ages18 Years and up
SexAll
SponsorDaiichi Sankyo (industry)
Drugs / interventionstrastuzumab, nivolumab, ramucirumab, pembrolizumab, chemotherapy
Locations76 sites (Klagenfurt and 75 other locations)
Trial IDNCT05993234 on ClinicalTrials.gov

What this trial studies

This observational study investigates the effectiveness of Trastuzumab deruxtecan (T-DXd) in patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received a trastuzumab-based treatment. It will collect data on patient demographics, clinical characteristics, treatment patterns, and safety events associated with T-DXd. Additionally, a disease registry will gather information on conventional therapies used in this patient population. The study aims to provide insights into the tolerability and effectiveness of T-DXd as a second-line treatment and beyond.

Who should consider this trial

Good fit: Ideal candidates include adult patients aged 18 and older with confirmed HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma who have previously received a trastuzumab-based regimen.

Not a fit: Patients currently participating in a blinded interventional study or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the effectiveness and safety of T-DXd, potentially improving treatment options for patients with advanced HER2-positive gastric cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches, particularly in the use of T-DXd for HER2-positive cancers, indicating a potential for success in this study.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male or female adult patient (age ≥ 18 years) with HER2 + advanced gastric or GEJ adenocarcinoma who have received a prior trastuzumab based regimen
* Histological or cytological confirmed diagnosis of advanced HER2 positive gastric cancer or GEJ
* Documented HER2 + status (archival sample or recent sample prior 2L therapy)
* Decision to newly initiate monotherapy T-DXd or conventional therapies per SMPC according to the physician's choice
* Written dated and signed Informed Consent (ICF) to participate in the study

Exclusion Criteria:

* Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded
* Pregnancy or breastfeeding

No specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the SmPC.

Where this trial is running

Klagenfurt and 75 other locations

+26 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: HER2-positive Advanced Gastric Cancer, HER2-positive Gastroesophageal Junction Adenocarcinoma, Trastuzumab Deruxtecan, Conventional therapy, ENHERTU®

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.