Trastuzumab Deruxtecan: T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
pembrolizumab: Pembrolizumab will be administered at a dose of 200 mg IV Q3W
Trastuzumab: Trastuzumab will be administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg IV Q3W
Chemotherapy: For Arms M1 and E1: 5-FU or capecitabine will be administered.
For Arms M2 and E2: Cisplatin plus 5-FU or oxaliplatin plus capecitabine will be administered.
Study 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-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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria
1. 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 any trial-specific qualification procedures. Sign and date the Optional PGx ICF (included in the Main Screening ICF) prior to any PGx procedure.
2. 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 \>18 years old.
3. Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma histologically confirmed by pathology report. Prior treatment in the perioperative and/or adjuvant setting is permissible, provided there is \>6 months between the end of perioperative or neoadjuvant treatment and the diagnosis of recurrent disease.
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 therapy and the diagnosis of recurrent disease.
4. Centrally determined HER2-positive (IHC 3+ or IHC 2+/ISH-positive) gastric or GEJ cancer as classified by the American Society of Clinical Oncology-College of American Pathologists for GC on a tumor biopsy as detected by prospective central test on new (core, incisional, excisional biopsy) or existing tumor tissue taken at the time of diagnosis of locally advanced or metastatic disease.
Note: Archival samples taken from a previous diagnostic or surgical biopsy not previously irradiated can be accepted. Details pertaining to tumor tissue submission can be found in the Study Laboratory Manual.
5. 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
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.
Exclusion Criteria
1. Prior exposure to other HER2-targeting therapies (including ADCs).
2. Lack of physiological integrity of the upper gastrointestinal tract (ie, severe Crohn disease that results in malabsorption) or malabsorption syndrome that would preclude feasibility of oral chemotherapy for participants planned to be offered capecitabine as part of the study treatment.
3. Known total or partial 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 followed. In Spain and Italy, screening for DPD enzyme deficiency is mandatory for all participants with unknown DPD status.
4. Contraindications to trastuzumab, 5-FU, capecitabine, cisplatin, or oxaliplatin treatment as per local label.
5. Medical history of myocardial infarction within 6 months before randomization or symptomatic CHF (New York Heart Association Class II to IV). Participants with troponin levels above ULN at Screening (as defined by the manufacturer) and without any myocardial infarction -related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.
6. Has a corrected QT interval (QTcF) prolongation to \>470 ms (females) or \>450 ms (males) based on the average of the screening triplicate 12-lead ECG.
7. Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
8. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc).
Primary outcome measure(s)
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.
Trial sites (250)
Facility
City
Region
Status
Yale Cancer Center
New Haven
Connecticut
Not Yet Recruiting
Orchard Healthcare Research Inc.
Skokie
Illinois
Recruiting
University of Kansas Medical Center Research Institute, Inc.
Kansas City
Kansas
Not Yet Recruiting
Maryland Oncology Hematology, P.A.
Silver Spring
Maryland
Not Yet Recruiting
Tufts Medical Center
Boston
Massachusetts
Recruiting
University of Michigan Comprehensive Cancer Center Michigan Medicine
Ann Arbor
Michigan
Recruiting
Minnesota Oncology Hematology, P.A.
Minneapolis
Minnesota
Withdrawn
Memorial Sloan Kettering Cancer Center - MAIN
New York
New York
Recruiting
Montefiore Medical Center
The Bronx
New York
Recruiting
Providence Portland Medical Center
Portland
Oregon
Recruiting
Penn State University Milton S. Hershey Medical Center
Hershey
Pennsylvania
Recruiting
Prisma Health Cancer Institute, ITOR, CRU
Greenville
South Carolina
Recruiting
Tennessee Oncology Nashville Midtown
Nashville
Tennessee
Withdrawn
UT Southwestern Medical Center
Dallas
Texas
Recruiting
Texas Oncology, P.A. - Tyler
Tyler
Texas
Not Yet Recruiting
Virginia Oncology Associates
Norfolk
Virginia
Not Yet Recruiting
Blue Ridge Cancer Care
Roanoke
Virginia
Not Yet Recruiting
Wenatchee Valley Hospital & Clinics
Wenatchee
Washington
Withdrawn
CEMIC Ciudad Autonoma
Buenos Aires
Argentina
Not Yet Recruiting
Instituto Medico Especializado Alexander Fleming
Buenos Aires
Argentina
Recruiting
Clinica Universitaria Privada Reina Fabiola
Córdoba
Argentina
Recruiting
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata
Argentina
Recruiting
Instituto Medico de la Fundacion Estudios Clinicos
Rosario
Argentina
Recruiting
Flinders Medical Centre
Bedford Park
Australia
Recruiting
Monash Medical Centre Clayton
Clayton
Australia
Recruiting
Townsville University Hospital
Douglas
Australia
Recruiting
Peter MacCallum Cancer Centre
North Melbourne
Australia
Recruiting
GenesisCare North Shore (Oncology)
St Leonards
Australia
Recruiting
St John of God Subiaco Hospital
Subiaco
Australia
Recruiting
Wollongong Hospital
Wollongong
Australia
Recruiting
LKH - Universitaetsklinikum Graz
Graz
Austria
Recruiting
Medizinische Universität Innsbruck
Innsbruck
Austria
Recruiting
Medizinische Universität Wien
Vienna
Austria
Recruiting
St. Josef Krankenhaus Wien
Vienna
Austria
Recruiting
Landesklinikum Wiener Neustadt
Wiener Neustadt
Austria
Recruiting
Institut Jules Bordet
Anderlecht
Belgium
Recruiting
AZ Sint-Lucas
Bruges
Belgium
Recruiting
Cliniques Universitaires Saint-Luc
Brussels
Belgium
Recruiting
UZ Leuven
Leuven
Belgium
Recruiting
Centre Hospitalier Universitaire de Liege
Liège
Belgium
Recruiting
+ 210 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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