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Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab for Gastric or GEJ Cancer

This study is testing different combinations of medicines for advanced HER2-positive gastric (stomach) or gastroesophageal junction (GEJ) cancer. Researchers are comparing trastuzumab deruxtecan (T-DXd) plus a chemotherapy drug (fluoropyrimidine) and pembrolizumab against standard chemotherapy plus trastuzumab and pembrolizumab. The goal is to see how well these combinations work and if they are safe as a first treatment. To join, you must be at least 18 years old and have HER2-positive cancer. The main way they will measure success is by how long people live without their cancer getting worse (Progression Free Survival or PFS). The study plans to enroll 726 participants.

Study design
This is an interventional study comparing different drug combinations. It plans to enroll 726 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the date of randomization until their cancer progresses or they die, for up to 59 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06731478

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Daiichi Sankyo
~726 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Trastuzumab DeruxtecanpembrolizumabTrastuzumabChemotherapy

At a glance

Recruiting sites
219 of 250 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS)
Measured over From date of randomization to the date of radiographic disease progression or death due to any cause, up to 59 months

Conditions

Gastric Cancer
Gastroesophageal Junction Cancer

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Gastric CarcinomaGastroesophageal Junction Adenocarcinoma

Where it's being run

250 sites across 40 states
China27
Japan17
Spain17
France16
Italy16
South Korea14
Brazil12
Turkey (Türkiye)10

Who to contact

Contact for Trial Information
[email protected]
908-992-6400
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Eligibility criteria

Inclusion

For the Main Cohort: PD-L1 CPS ≥1
For the Exploratory Cohort: PD-L1 CPS \<1 6. All participants must provide a tumor sample for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 CPS, and other correlatives. The mandatory FFPE or new biopsy tumor sample can be from either the primary tumor or metastatic biopsy. Specimens with limited tumor content (as centrally determined) and cytology samples are inadequate for defining tumor HER2 and PD-L1 status. 7. At least 1 target measurable lesion on CT or MRI, assessed by the investigator based on RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions. 8. LVEF ≥50% within 28 days before randomization.

What this trial measures

  • 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.