Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
Phase 3
Not yet recruiting
- Conditions
- Interventions
- Registration Number
- NCT06731478
- Lead Sponsor
- Daiichi Sankyo
- Brief 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...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 726
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Main Cohort: Arm M1 Trastuzumab Deruxtecan Participants will receive T-DXd plus fluoropyrimidine (5-FU or capecitabine) plus pembrolizumab Main Cohort: Arm M1 Pembrolizumab Participants will receive T-DXd plus fluoropyrimidine (5-FU or capecitabine) plus pembrolizumab Main Cohort: Arm M1 Chemotherapy Participants will receive T-DXd plus fluoropyrimidine (5-FU or capecitabine) plus pembrolizumab Main Cohort: Arm M2 Pembrolizumab Participants will receive Trastuzumab plus platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine) plus pembrolizumab Main Cohort: Arm M2 Trastuzumab Participants will receive Trastuzumab plus platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine) plus pembrolizumab Main Cohort: Arm M2 Chemotherapy Participants will receive Trastuzumab plus platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine) plus pembrolizumab Exploratory Cohort: Arm E1 Trastuzumab Deruxtecan Participants will receive T-DXd plus fluoropyrimidine (5-FU or capecitabine) Exploratory Cohort: Arm E1 Chemotherapy Participants will receive T-DXd plus fluoropyrimidine (5-FU or capecitabine) Exploratory Cohort: Arm E2 Trastuzumab Participants will receive Trastuzumab plus platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine) Exploratory Cohort: Arm E2 Chemotherapy Participants will receive Trastuzumab plus platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine)
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) From date of randomization to the date of radiographic disease progression or death due to any cause, up to 59 months PFS is defined as the time interval from the date of randomization to the date of radiographic disease progression as assessed by blinded independent central review (BICR) based on RECIST v1.1 or death due to any cause
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) From date of randomization to the date of death due to any cause, up to 59 months OS is defined as the time interval from the date of randomization to the date of death due to any cause