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HER2-positive Advanced Gastric CancerNCT05993234

A Study of Trastuzumab DeRuxtecan for Patients With Advanced HER2-pOsitive GaStric or GastroesoPhageal Junction AdEnocarcinoma Who Have Received a PrIor Trastuzumab-based Regimen Accompanied by a Disease RegistrY of Patients Treated With Conventional Therapies (PROSPERITY)

An observational study of HER2-positive Advanced Gastric Cancer and HER2-positive Gastroesophageal Junction Adenocarcinoma, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 39 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Trastuzumab deruxtecan (T-DXD) as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Trastuzumab deruxtecan
How many people
257 participants
Where
39 sitesin 4 countries
Study dates
5 Dec 2023to 1 Sep 2027
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with advanced HER2-positive gastric or GEJ adenocarcinoma who have received a prior trastuzumab-based regimen in a real-world setting in Europe.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

39 sites in 4 countries.

39 sites in 4 countries

Germany14 sites

  • MVZ am Klinikum Aschaffenburg

    Aschaffenburg, 63739

  • Vivantes Klinikum im Friedrichshain

    Berlin, 10249

  • Charite Campus Benjamin Franklin

    Berlin, 12203

  • MV-Zentrum für Hämatologie & Onkologie

    Cologne, 50677

  • University Hospital Essen

    Essen, 45147

  • Alb Fils Kliniken GmbH

    Göppingen, 73035

  • Hämatologisch-Onkologische Praxis Eppendorf (HOPE)

    Hamburg, 20249

  • Studienzentrum am Raschplatz GbR

    Hanover, 30161

  • KRH Klinikum Siloah

    Hanover, 30459

  • Gemeinschaftspraxis Dr. Haytham Kamal / Dr. David C. Dorn

    Hanover, 30625

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675

  • Klinikum am Steinenberg Reutlingen

    Reutlingen, 72764

  • CaritasKlinikum Saarbrücken

    Saarbrücken, 66113

  • Praxis Onkologie Rheinsieg

    Troisdorf, 53840

Other trials in Germany

Italy14 sites

  • IRCCS "S. De Bellis"

    Castellana Grotte, 70013

  • ARNAS Garibaldi - PO Nesima

    Catania, 95122

  • AOU Careggi

    Florence, 50134

  • IRCCS AOU San Martino

    Genova, 16132

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Azienda Ospedaliero-Universitaria di Modena

    Modena, 41124

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Naples, 80131

  • Università degli studi di Napoli Federico II

    Naples, 80131

  • Università della Campania 'Luigi Vanvitelli'

    Naples, 80131

  • AOU Pisana - Stabilimento Santa Chiara

    Pisa, 56126

  • AUSL della Romagna - Ospedale "S. Maria delle Croci" di Ravenna

    Ravenna, 48121

  • Policlinico Universitario Campus Bio-Medico

    Roma, 00128

  • AO "Cardinale Giovanni Panico"

    Tricase, 73039

Other trials in Italy

Belgium6 sites

  • OLV Hospital Aalst

    Aalst, 9300

  • Antwerp University Hospital

    Edegem, 2650

  • UZ Gent

    Ghent, 9000

  • CHU Helora Hospital de La Louvière - Site Jolimont

    Haine-Saint-Paul, 7100

  • JESSA Hasselt

    Hasselt, 3500

  • UZ Brussel

    Jette, 3000

Other trials in Belgium

Austria5 sites

  • Ordensklinikum Linz GmbH Barmherzige Schwestern

    Linz, 4010

  • Medizinische Universität Wien

    Vienna, 1090

  • Kepler Universitätsklinikum

    Wels, 4600

  • Landesklinikum Wiener Neustadt

    Wiener Neustadt, 2700

  • Krankenhaus St. Vinzenz in Zams

    Zams, 6511

Other trials in Austria

About this study

Official title: 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)

Trastuzumab deruxtecan (T-DXD) as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

This study will assess the effectiveness of T-DXd, patient demographic and clinical characteristics, and treatment patterns in patients with advanced HER2-positive advanced gastric or GEJ adenocarcinoma.

Read the detailed description

This non-interventional study will investigate the effectiveness of T-DXd, the patients demographic and clinical characteristics, treatment patterns including prophylactic medications and interventions for reduction of serious adverse events (SAEs), serious adverse drug reactions (ADRs) and safety event of interest (SEIs), tolerability, and patient survey of T-DXd, in cases with advanced HER2-positive gastric or GEJ adenocarcinoma receiving T-DXd as second line of treatment and beyond treatment option. Patients will be treated according to the proposed indication statement in the Summary of Product Characteristics (SmPC). No investigational drug will be administered in this study.

Data on conventional therapy (including platinum-fluoropyrimidine doublet chemotherapy, nivolumab, ramucirumab-paclitaxel, ramucirumab monotherapy, taxane or irinotecan, and pembrolizumab monotherapy) will also be collected in a disease registry part of the study.

Being tested
Trastuzumab deruxtecan
Keywords
HER2-positive Advanced Gastric Cancer, HER2-positive Gastroesophageal Junction Adenocarcinoma, Trastuzumab Deruxtecan, Conventional therapy, ENHERTU®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab deruxtecanDrug

    Also called T-DXd, ENHERTU®

    This is a non-interventional study and medication will be administered according to the SmPC as local standard of care and as part of the routine clinical practice.

    T-DXd to be administered according to the SmPC. Conventional therapy (eg. platinum-fluoropyrimidine doublet chemotherapy, nivolumab, ramucirumab-paclitaxel, ramucirumab monotherapy, taxane or irinotecan, and pembrolizumab monotherapy) to be administered according to the SmPC.

Study groups in NCT05993234
Study groupRoleWhat they receive
Trastuzumab deruxtecan (T-DXd)Participants with HER2-positive gastric or gastroesophageal junction adenocarcinoma who will be treated with trastuzumab deruxtecan and part of the enrolled participants will receive conventional therapy. The participants on conventional therapy will be analyzed for exploratory purposes only.
Receives: Drug: Trastuzumab deruxtecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Real-World Time to Next Treatment (rwTTNT1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

    Measured: Baseline up to approximately 2 years

Secondary outcomes (6)

  1. Number of Physician Visits and Treatment Changes in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

    Measured: Baseline up to approximately 2 years

  2. Number of Physician-reported Safety Events of Interest in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (T-DXd only)

    Measured: Baseline up to approximately 2 years

  3. Number of Participants Receiving Prophylactic and Reactive Treatment Management for Physician-reported Safety Events of Interest in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (T-DXd only)

    Measured: Baseline up to approximately 2 years

  4. Real-World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

    Measured: Baseline up to approximately 2 years

  5. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scores in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

    The EORTC QLQ-C30 questionnaire is a cancer-specific quality of life instrument applicable to a broad range of cancer patients. The EORTC QLQ-C30 scales and single-item scales range in score from 0 to 100. A higher score for the functioning scales and global health status denotes a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).

    Measured: Baseline up to approximately 2 years

  6. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Stomach (EORTC QLQ-STO22) Score in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

    The EORTC QLQ-STO22 is a gastric cancer-specific module which has been developed to measure the quality of life in patients with gastric cancer. The gastric cancer specific questions on the EORTC QLQ-STO22 include four single-item subscales (dry mouth, body image, hair loss and problems with taste) and five multi-item subscales (dysphagia, dietary restriction, pain, upper gastroesophageal symptoms and emotional problems). The EORTC QLQ single-item and multi-item scales range in score from 0 to 100. A higher score on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient)

    Measured: Baseline up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2023
  2. Study start5 Dec 2023
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
257 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05993234
Sponsor's protocol ID
DS8201-0007-NIS-MA
Status last verified
Aug 2026
First submitted
2 Aug 2023
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of HER2-positive Advanced Gastric Cancer and HER2-positive Gastroesophageal Junction Adenocarcinoma, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 39 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Germany, Italy, Belgium, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Real-World Time to Next Treatment (rwTTNT1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (time frame: Baseline up to approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05993234.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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