Clinical Trials - DataSource by Daiichi Sankyo

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)

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.

CONDITIONS

HER2-positive Advanced Gastric Cancer, HER2-positive Gastroesophageal Junction Adenocarcinoma

PRODUCT

T-DXd

GENDER

ALL

AGE

18 Years

SPONSOR

Daiichi Sankyo

COLLABORATOR

TRIAL RUNS IN

68 Global Locations

Trial Summary

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.

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)

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

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 breastfeedingNo specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the SmPC.

This was last updated on 2025-11-06 19:34:41.997.

The content contained is taken is taken directly from public registry ClinicalTrials.gov and has not been edited.

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