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Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer

StatusRecruiting
PhasePhase 3
Started2025-02-27
View on ClinicalTrials.gov ↗

Amendment history

2026-08-06
Study Status, Contacts/Locations v18
Study sitesdetails revised at 7 of 250 sites
2026-07-14
Study Status, Contacts/Locations v17
Study sitesdetails revised at 4 of 250 sites
2026-06-29
Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v16
Eligibility criteria+354 characters
Inclusion Criteria Sign and date the Tissue Prescreening ICF, prior to central HER2 and PD-L1 CPS central testing. Sign and date the Main Screening ICF, prior to the [...] sue submission can be found in the Study Laboratory Manual. Centrally determined tumor PD-L1 CPS using the PD-L1 assay: For the Main Cohort: PD-L1 CPS ≥1 For the Exploratory Cohort: PD-L1 CPS <1 All participants must provide a tumor sample for tissue-base [...] ssion, PD-L1 CPS, and other correlatives. The mandatory FFPE or new biopsy tumor sample can be from either the primary tumor or metast [...] uch lesions. LVEF ≥50% within 28 days before [...]
Secondary endpointsdetails revised at 1 of 1 entry
Study sitesdetails revised at 18 of 250 sites
2026-03-13
Study Status, Contacts/Locations v15
Study sites249→250
2026-02-06
Study Status, Contacts/Locations v14
Study sitesdetails revised at 13 of 249 sites
Show 13 earlier versions
2026-01-09
Study Status, Contacts/Locations v13
Study sites248→249
2025-12-04
Study Status, Contacts/Locations v12
Study sitesdetails revised at 32 of 248 sites
2025-11-21
Study Status, Contacts/Locations v11
Study sites245→248
2025-10-22
Study Status, Contacts/Locations v10
Study sitesdetails revised at 32 of 245 sites
2025-09-10
Study Status, Contacts/Locations v9
Study sitesdetails revised at 17 of 245 sites
2025-08-06
Study Status, Contacts/Locations v8
Study sites246→245
2025-07-30
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 246 sites
2025-07-09
Study Status, Contacts/Locations v6
Study sites31→246
2025-06-11
Study Status, Contacts/Locations v5
Study sites27→31
2025-06-05
Study Status, Contacts/Locations v4
Study sites5→27
2025-06-04
Study Status, Eligibility v3
Eligibility criteria+142 characters
[...] bine). Known DPD enzyme deficiency. Note: Screening for DPD enzyme deficiency is required only in regions/countries where DPD testing is SoC and with unknown DPD status. For regions/countries where DPD testing is not SoC, local practice should be conducted per local requirementsfollowed. Contraindications to trastuzumab, 5-FU, capecitabine, cisp [...]
2025-04-09
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-03-01→confirmed 2025-02-27
Study sites0→5
2025-01-28
Study Identification, Study Status, Sponsor/Collaborators, Arms and Interventions, Eligibility v1
InterventionsChemotherapy (Drug), Pembrolizumab (Drug), Trastuzumab (Drug), Trastuzumab Deruxtecan (Drug)→Chemotherapy (Drug), Trastuzumab (Drug), Trastuzumab Deruxtecan (Drug), pembrolizumab (Drug)
Eligibility criteria-150 characters
[...] ociety of Clinical Oncology-College of American Pathologists 1 for GC on a tumor biopsy as detected by prospective central [...] sue submission can be found in the Study Laboratory Manual. Centrally determined tumor PD-L1 CPS using the PD-L1 22C3 PharmDx assay: For the Main Cohort: PD-L1 CPS ≥1 For the Exploratory Cohort: PD-L1 CPS <1 All participants must provide a tumor sample for tissue-base [...]
Collaborators+23 characters
Merck Sharp & Dohme LLC
2024-12-09
Original filing
Daiichi Sankyo
69 trials monitored
See 8 trials at risk
Gastric Cancer
1,194 trials monitored
See 60 trials at risk
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.
Trial Details
NCT Number NCT06731478
Lead Sponsor Daiichi Sankyo
Collaborators: Merck Sharp & Dohme LLC
Conditions Gastric Cancer, Gastroesophageal Junction Cancer
Enrollment 726 participants
Start Date 2025-02-27
Primary Completion 2028-06-01 (estimated)
Study Completion 2030-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-10