DESTINY-Gastric05 (protocol DS8201-724) is an international, multicenter, randomized Phase III trial evaluating trastuzumab deruxtecan (T-DXd) in combination with a fluoropyrimidine-based chemotherapy and optionally an anti-PD-1 agent, versus standard trastuzumab plus chemotherapy (and optionally anti-PD-1) in adult patients with untreated, unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction cancer (GEJ). The primary endpoint is progression-free survival (PFS) in the main cohort defined by PD-L1 CPS =1. Eligibility includes adult patients with HER2-positive tumours (central confirmation), untreated in the first-line metastatic or unresectable setting. HER2-status is confirmed centrally via IHC and/or ISH in the screening phase. Patients are randomized 1:1 to receive T-DXd combination therapy versus standard arm. Key secondary endpoints include objective response rate (ORR), duration of response (DoR), overall survival (OS) and treatment safety/tolerability profiles.
The DESTINY-Gastric05 study (DS8201-724) is investigating the new drug trastuzumab deruxtecan in combination with chemotherapy and possibly an immunotherapy in adult patients with unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction cancer. The aim is to evaluate whether this regimen can delay disease progression or improve survival. Adults with HER2-positive, advanced or metastatic gastric/GEJ cancer in the first-line setting are eligible. The HER2 molecular status is confirmed during screening. Participants are randomized: one arm receives trastuzumab deruxtecan plus chemotherapy (and possibly immunotherapy), the comparator arm receives the standard therapy of trastuzumab plus chemotherapy (and possibly immunotherapy). Key secondary endpoints include response rate, duration of response and treatment safety.
