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Clinical Trials List

Protocol NumberDS8201-724
NCT Number(ClinicalTrials.gov Identfier)NCT06731478
Active

2025-03-01 - 2030-02-01

Phase III

Recruiting5

ICD-10C16.0

Malignant neoplasm of cardia

ICD-10C7A.092

Malignant carcinoid tumor of the stomach

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9151.0

Malignant neoplasm of cardia of stomach

A Multicenter, Randomized, Open-Label, Phase 3 Trial of Trastuzumab Deruxtecan (Enhertu®) Plus Chemotherapy Plus or Minus Pembrolizumab Versus Chemotherapy Plus Trastuzumab Plus or Minus Pembrolizumab as First-Line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Gastric Or Gastroesophageal Junction (GEJ) Cancer (Destiny-Gastric05)

  • Trial Applicant

     Daiichi Sankyo Taiwan Ltd. 

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Jen-Shi Chen Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳彥仰 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Kun-Huei Yeh Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Huang Chen Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Gastric Cancer 、Gastroesophageal Junction Cancer

Objectives

This multicenter, randomized, open-label, phase 3 clinical trial is designed to evaluate trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) triplet fluoropyrimidine plus pembrolizumab compared to standard of care (SoC) chemotherapy plus trastuzumab plus pembrolizumab as first-line treatment in patients with unresectable, locally advanced, or metastatic HER2-positive tumors with PD-L1 CPS <1 in gastric or GEJ cancer. An exploratory cohort will also be evaluated to assess the efficacy and safety of T-DXd plus fluoropyrimidine compared to SoC chemotherapy plus trastuzumab in patients with unresectable, locally advanced, or metastatic HER2-positive tumors with PD-L1 CPS <1 in gastric or GEJ cancer.

Test Drug

Frozen Crystal Injection
Frozen Crystal Injection
Injection
Injection
Injection
Film-Coated Tablets
Injection

Active Ingredient

Frozen Crystal Injection
Frozen Crystal Injection
Injection
Injection
Injection
Film-Coated Tablets
Injection

Dosage Form

243
243
270
270
270
116
270

Dosage

100MG
150MG
100mg/4ml
200mg/40ml
100mg/100ml
500MG
1000mg/20ml

Endpoints

PFS (Progression-Free Surgery) is the time elapsed from randomization to the onset of objective radiographic worsening of the disease or death from any cause as assessed by RECIST v1.1.

[Time Range: PFS is defined as the time interval from the date of randomization to the date of worsening of the radiographic disease or death from any cause, up to a maximum of 59 months.]

Inclution Criteria

Inclusion

Sign and date the Tissue Prescreening ICF, prior to HER2 and PD-L1 CPS central 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.
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.
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.

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.

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 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.
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.
LVEF ≥50% within 28 days before randomization.

Exclusion Criteria

exclusion criteria

Prior exposure to other HER2-targeting therapies (including ADCs).
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 (ie, capecitabine).
Known 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.
Contraindications to trastuzumab, 5-FU, capecitabine, cisplatin, or oxaliplatin treatment as per local label.
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.
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.
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
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).

The Estimated Number of Participants

  • Taiwan

    31 participants

  • Global

    726 participants

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