A Phase 3, Multicenter, 2-Arm Randomized, Open-Label Study of Trastuzumab Deruxtecan in Subjects with HER2 Positive Metastatic and/or Unresectable Gastric or Gastro Esophageal Junction (GEJ) Adenocarcinoma Subjects who have Progressed on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507963-20-00

Acronym

DS8201-A-U306

Enrollment

213

Registered

2024-06-06

Start date

2021-08-19

Completion date

Unknown

Last updated

2025-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Gastric Adenocarcinoma

Brief summary

Overall Survival (OS)

Detailed description

Progression-Free Survival (PFS), Objective Response Rate (ORR), Duration of Response (DoR), Disease Control Rate (DCR), TEAEs and other safety parameters during the study, PK profile, Immunogenicity (Incidence of ADA and NAb)

Interventions

DRUGPACLITAXEL

DRUGCyramza 10 mg/ml concentrate for solution for infusion

DRUGDS-8201a

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS)	—

Secondary

Measure	Time frame
Progression-Free Survival (PFS), Objective Response Rate (ORR), Duration of Response (DoR), Disease Control Rate (DCR), TEAEs and other safety parameters during the study, PK profile, Immunogenicity (Incidence of ADA and NAb)	—

Countries

Belgium, France, Germany, Hungary, Ireland, Italy, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026