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

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

Trial Details

NCT ID
NCT06731478
Phase
PHASE3
Sponsor
Daiichi Sankyo
Status
RECRUITING
Cancer Type
Gastric Cancer
Interventions
  • Trastuzumab Deruxtecan
  • pembrolizumab
  • Trastuzumab
  • Chemotherapy
Locations (sample)
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Skokie, Illinois, United States|42.03336,-87.73339
  • Kansas City, Kansas, United States|39.11417,-94.62746
  • Silver Spring, Maryland, United States|38.99067,-77.02609
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Sign and date the Tissue Prescreening ICF, prior to central HER2 and PD-L1 CPS testing. Sign and date the Main Screening ICF, prior to the start of…
  • Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is …
  • Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma histologically confirmed by pathology report. Prio…
  • Note: Prior use of IO (ie, anti-PD-1/PD-L1) therapy in the (neo)adjuvant setting is allowed as long as there is \>6 months between the end of IO th…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Gastric Cancer Trials on Trialify →