At a glance
ClinicalIndex Comparison Record- ✓Adults ≥18 years of age
- ✓Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma histologically confirmed
- ✓>6 months between end of perioperative/neoadjuvant treatment and diagnosis of recurrent disease
- ✓>6 months between end of (neo)adjuvant IO therapy and diagnosis of recurrent disease
- ✕Prior exposure to other HER2-targeting therapies including ADCs
- ✕Lack of physiological integrity of upper GI tract or malabsorption syndrome precluding oral chemotherapy
- ✕Contraindications to trastuzumab, 5-FU, capecitabine, cisplatin, or oxaliplatin per local label
- ✕Myocardial infarction within 6 months before randomization or symptomatic CHF (NYHA Class II-IV)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Open-Label, Phase 3 Trial of Trastuzumab Deruxtecan (Enhertu®) Plus Chemotherapy Plus or Minus Pembrolizumab Versus Chemotherapy Plus Trastuzumab Plus or Minus Pembrolizumab as First-Line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Gastric Or Gastroesophageal Junction (GEJ) Cancer (Destiny-Gastric05)
In Brief
A Phase 3 clinical trial evaluating Trastuzumab Deruxtecan, pembrolizumab, and 2 other interventions for Gastric Cancer and Gastroesophageal Junction Cancer. Currently recruiting, targeting 726 participants across 250 sites in 26 countries.
Signals
Detailed Summary
This clinical trial is designed to assess the efficacy and safety of the triplet combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus standard of care (SoC) chemotherapy plus trastuzumab plus pembrolizumab as first-line therapy in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS ≥1 gastric or GEJ cancer in the Main Cohort. An Exploratory Cohort will also be evaluated to assess the efficacy and safety of T-DXd plus a fluoropyrimidine versus SoC chemotherapy plus trastuzumab in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS \<1 gastric or GEJ cancer.
Study Details
Timeline
Interventions
T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
Pembrolizumab will be administered at a dose of 200 mg IV Q3W
Trastuzumab will be administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg IV Q3W
For Arms M1 and E1: 5-FU or capecitabine will be administered. For Arms M2 and E2: Cisplatin plus 5-FU or oxaliplatin plus capecitabine will administered.