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.
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 of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
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Yale Cancer Center, New Haven, Connecticut, United States, 06520-8028
Orchard Healthcare Research Inc., Skokie, Illinois, United States, 60077
University of Kansas Medical Center Research Institute, Inc., Kansas City, Kansas, United States, 66160
Maryland Oncology Hematology, P.A., Silver Spring, Maryland, United States, 20904
Tufts Medical Center, Boston, Massachusetts, United States, 02111
University of Michigan Comprehensive Cancer Center Michigan Medicine, Ann Arbor, Michigan, United States, 48109
Minnesota Oncology Hematology, P.A., Minneapolis, Minnesota, United States, 55407
Montefiore Medical Center, Bronx, New York, United States, 10467
Memorial Sloan Kettering Cancer Center - MAIN, New York, New York, United States, 10065
Providence Portland Medical Center, Portland, Oregon, United States, 97213
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
Daiichi Sankyo,
2030-02-01