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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06731478




Registration number
NCT06731478
Ethics application status
Date submitted
9/12/2024
Date registered
12/12/2024
Date last updated
12/09/2025

Titles & IDs
Public title
Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
Scientific title
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)
Secondary ID [1] 0 0
KEYNOTE-G03
Secondary ID [2] 0 0
DS8201-724
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 0 0
Gastroesophageal Junction Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Trastuzumab Deruxtecan
Treatment: Drugs - pembrolizumab
Treatment: Drugs - Trastuzumab
Treatment: Drugs - Chemotherapy

Experimental: Main Cohort: Arm M1 - Participants will receive T-DXd plus fluoropyrimidine (5-FU or capecitabine) plus pembrolizumab

Experimental: Main Cohort: Arm M2 - Participants will receive Trastuzumab plus platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine) plus pembrolizumab

Experimental: Exploratory Cohort: Arm E1 - Participants will receive T-DXd plus fluoropyrimidine (5-FU or capecitabine)

Experimental: Exploratory Cohort: Arm E2 - Participants will receive Trastuzumab plus platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine)


Treatment: Drugs: Trastuzumab Deruxtecan
T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)

Treatment: Drugs: pembrolizumab
Pembrolizumab will be administered at a dose of 200 mg IV Q3W

Treatment: Drugs: Trastuzumab
Trastuzumab will be administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg IV Q3W

Treatment: Drugs: 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 administered.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
From date of randomization to the date of radiographic disease progression or death due to any cause, up to 59 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From date of randomization to the date of death due to any cause, up to 59 months

Eligibility
Key inclusion criteria
Inclusion

1. 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.
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. 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.
6. 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.
7. 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 (ie, capecitabine).
3. 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.
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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2030
Actual
Sample size
Target
726
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Monash Medical Centre Clayton - Clayton
Recruitment hospital [3] 0 0
Townsville University Hospital - Douglas
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - North Melbourne
Recruitment hospital [5] 0 0
GenesisCare North Shore (Oncology) - St Leonards
Recruitment hospital [6] 0 0
St John of God Subiaco Hospital - Subiaco
Recruitment hospital [7] 0 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Douglas
Recruitment postcode(s) [4] 0 0
- North Melbourne
Recruitment postcode(s) [5] 0 0
- St Leonards
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- Subiaco
Recruitment postcode(s) [7] 0 0
- Wollongong
Recruitment outside Australia
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Laval
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Chemnitz
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Heidelberg
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Catania
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Pisa
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Rome
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Rozzano
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San Giovanni Rotondo
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Torino
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Italy
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Tricase
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Bunkyo City
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Chuoku
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Gifu
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Nagoya
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Natori-shi
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Niigata
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Osaka
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Osakasayama-shi
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Sapporo
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Yokohama
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Netherlands
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Amsterdam
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Nijmegen
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Bergen
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Oslo
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Poznan
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Braga
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Guimarães
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Lisbon
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Portugal
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Porto
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Romania
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Bucharest
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Romania
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Cluj-Napoca
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Craiova
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Romania
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Ia?i
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Ovidiu
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Daegu
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L'Hospitalet de Llobregat
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Madrid
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Málaga
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Murcia
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Pamplona
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Seville
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Valencia
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkoknoi
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Thailand
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Dusit
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Thailand
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Hat Yai
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Thailand
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Laksi
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Thailand
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Pathum Wan
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Turkey (Türkiye)
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Adana
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Turkey (Türkiye)
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Ankara
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Turkey (Türkiye)
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Diyarbakir
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Turkey (Türkiye)
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Erzurum
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Turkey (Türkiye)
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Istanbul
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Turkey (Türkiye)
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Izmir
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Turkey (Türkiye)
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Samsun
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United Kingdom
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Birmingham
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United Kingdom
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Cardiff
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United Kingdom
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Dundee
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United Kingdom
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Hull
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United Kingdom
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Leeds
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London
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United Kingdom
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Londonderry
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Manchester
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Sutton
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Vietnam
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Hanoi
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Vietnam
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Ho Chi Minh City
Country [198] 0 0
Vietnam
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HoChiMinh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Daiichi Sankyo
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Available to whom?
Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/daiichi-sankyo/


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06731478