Clinical trial • Phase III • Oncology|Gastroenterology

TRASTUZUMAB DERUXTECAN for HER2-positive gastric cancer|HER2-positive gastroesophageal junction (GEJ) cancer

Phase III trial of TRASTUZUMAB DERUXTECAN for HER2-positive gastric cancer|HER2-positive gastroesophageal junction (GEJ) cancer.

Overview

Trial Therapeutic Area: Oncology|Gastroenterology
Trial Disease: HER2-positive gastric cancer|HER2-positive gastroesophageal junction (GEJ) cancer
Trial Stage: Phase III
Drug Modality: ADC|Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date: 18-12-2024
First CTIS Authorization Date: 29-04-2025

Trial design

Randomised, open-label, comparator arms: trastuzumab plus platinum-based chemotherapy (cisplatin plus 5-fu or oxaliplatin plus capecitabine) with or without pembrolizumab (as described for arm m2/e2). comparator regimen details (dose/schedule) not specified in the ctis metadata.-controlled Phase III trial in Romania, Austria, Czechia and others.

Randomised: Yes
Open Label: Yes
Comparator: Comparator arms: Trastuzumab plus platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine) with or without pembrolizumab (as described for Arm M2/E2). Comparator regimen details (dose/schedule) not specified in the CTIS metadata.
Biomarker Stratified: True, PD-L1 CPS: Main Cohort PD-L1 CPS ≥1 | Exploratory Cohort PD-L1 CPS <1
Target Sample Size: 726

Eligibility

Recruits 726 The trial is limited to adults (Adults ≥18 years of age on the day of signing the ICF); local regulatory requirements apply if the legal age of consent is >18. Vulnerable population flag is set. Informed consent requirements: participants must sign and date the Tissue Prescreening ICF, the Main Screening ICF (and Optional PGx ICF if applicable) prior to trial-specific procedures; pregnancy and partner ICFs are included. For PRO collection, if a participant is unable to read the questionnaire (ie, blind or illiterate) or if a language version is not available, the participant is exempted from completing PRO questionnaires but may still participate. (Consent and ICFs are provided per local language/region-specific documents.).

Pregnancy Exclusion: Is pregnant or breastfeeding or planning to become pregnant.
Vulnerable Population: The trial is limited to adults (Adults ≥18 years of age on the day of signing the ICF); local regulatory requirements apply if the legal age of consent is >18. Vulnerable population flag is set. Informed consent requirements: participants must sign and date the Tissue Prescreening ICF, the Main Screening ICF (and Optional PGx ICF if applicable) prior to trial-specific procedures; pregnancy and partner ICFs are included. For PRO collection, if a participant is unable to read the questionnaire (ie, blind or illiterate) or if a language version is not available, the participant is exempted from completing PRO questionnaires but may still participate. (Consent and ICFs are provided per local language/region-specific documents.)

Inclusion criteria

{"criterion_text":"- 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.\n- 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.\n- 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.\n- 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.\n- Centrally determined tumor PD-L1 CPS using the PD-L1 22C3 PharmDx assay: • For the Main Cohort: PD-L1 CPS ≥1 • For the Exploratory Cohort: PD-L1 CPS <1.\n- 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.\n- 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 measurif progression has been shown in such lesions.\n- LVEF ≥50% within 28 days before randomization.\n- ECOG performance status of 0 or 1 assessed 7 days before randomization\n- Adequate organ and bone marrow function within 14 days before randomization. Transfusion (red blood cell or platelet) or G-CSF administration is not allowed within 14 days prior to the day on which bone marrow function is assessed or at any time after this day and prior to Cycle 1 Day 1. Please refer to the protocol for further details..\n- Adequate treatment washout period before randomization. Please refer to the protocol for further details.\n- Male and female participants of reproductive/childbearing potential must agree to use a highly effective form of contraception, as detailed in Section 10.3.4, or avoid intercourse during trial intervention and for at least 7 months for females and 4 months for males after the last dose of trial intervention. Please refer to the protocol for further details.\n- Male participants must not freeze or donate sperm starting at randomization and throughout the trial period, and at least 4 months after the last dose of T-DXd. For participants receiving pembrolizumab, trastuzumab, 5-FU, capecitabine, cisplatin, or oxaliplatin, sites should follow local label or institutional guidelines. Preservation of sperm should be considered prior to randomization in this trial.\n- Female participants must not donate, or retrieve for their own use, ova from the time of randomization and throughout the trial intervention period, and for at least 7 months after the last dose of T-DXd. For participants receiving pembrolizumab, trastuzumab, 5-FU, capecitabine, cisplatin, or oxaliplatin, sites should follow local label or institutional guidelines. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to randomization in this trial.\n- Is willing and able to comply with scheduled visits, trial intervention plan, laboratory tests, other trial procedures, and trial restrictions.\n- Is willing and able to participate in the collection of PRO data. Note: If a participant is unable to read the questionnaire (ie, blind or illiterate) or if the linguistic version is not available for the participant’s native or preferred language, that participant will be exempted from completing PRO questionnaires but may still participate in the trial."}

Exclusion criteria

{"criterion_text":"- Prior exposure to other HER2-targeting therapies (including ADCs).\n- Prior pneumonectomy (complete).\n- Has spinal cord compression, known clinically active central nervous system metastases (defined as untreated and symptomatic) and/or carcinomatous meningitis. Note: Participants with previously treated brain metastases may participate provided they a) are radiologically stable (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during trial screening, b) are clinically stable (ie, asymptomatic and have not required steroid treatment or anticonvulsant for at least 14 days before the first dose of trial intervention), and c) have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and trial randomization.\n- Has known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, who have undergone potentially curative therapy are not excluded.\n- Has a history of severe hypersensitivity reactions (≥Grade 3) to either the drug substances or inactive ingredients in the drug product.\n- Has an uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals.\n- Has substance abuse, other medical conditions such as clinically significant cardiac or psychological conditions, or any other circumstance such that it is not in the best interest of the participant to participate, that may, in the opinion of the investigator, interfere with the participant’s participation in the clinical trial or evaluation of the clinical trial results.\n- Has an active primary immunodeficiency, known uncontrolled active HIV infection, including HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease. Note: HIV testing is required prior to randomization for all participants enrolled in the EU and Japan. For other regions, HIV testing should be performed if required by local regulations or IRB/EC.\n- Has active or uncontrolled hepatitis B virus infection. Participants are eligible if they meet the criteria below: a. HBsAg positive with chronic HBV infection (lasting 6 months or longer) and meet the additional conditions below: • HBV DNA viral load <2000 IU/mL • Start or maintain antiviral treatment if clinically indicated as per the investigator b. Normal transaminase values, or if liver metastases are present, has abnormal transaminase values with AST/ALT <3 × ULN that are not attributable to HBV infection.\n- Has active or uncontrolled hepatitis C virus infection. Participants are eligible if they meet the conditions below: a. History of hepatitis C infection with an HCV viral load that is below the level of detection in the absence of antiviral therapy during the previous 4 weeks. b. Normal transaminase values or, if liver metastases are present, abnormal transaminase values with AST/ALT <3 × ULN that are not attributable to HCV infection.\n- Has history of receiving live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trial intervention.\n- 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).\n- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to ≤Grade 1 or baseline.\n- Is pregnant or breastfeeding or planning to become pregnant.\n- Applicable for main cohort only: Has an active autoimmune disease that has required systemic treatment in past 2 years(ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment and is allowed.\n- Applicable for main cohort only: Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of trial intervention.\n- Applicable for main cohort only: Has a known history of active tuberculosis (Mycobacterium tuberculosis). No testing for tuberculosis is required unless mandated by local health authority.\n- 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.\n- Contraindications to trastuzumab, 5-FU, capecitabine, cisplatin, or oxaliplatin treatment as per local label.\n- 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.\n- 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.\n- 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.\n- 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).\n- Any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis,Sjogren’s, sarcoidosis etc) where there is documented, or a suspicion of, pulmonary involvement at the time of screening. Full details of the disorder should be recorded in the eCRF for participants who are included in the trial."}

Endpoints

Primary endpoints

{"endpoint_text":"- PFS is defined as the time interval from the date of randomization to the date of radiographic disease progression or death due to any cause.","definition_or_measurement_approach":"Time from randomization to radiographic disease progression or death; primary objective specifies PFS based on BICR assessment (blinded independent central review)."}

Secondary endpoints

{"endpoint_text":"- OS is defined as the time interval from the date of randomization to the date of death due to any cause.","definition_or_measurement_approach":"Time from randomization to death from any cause."}
{"endpoint_text":"- Incidence of TEAEs, SAEs, AESIs, deaths, ECOG performance status, vital signs, clinical laboratory results, ECGs, and ECHO/MUGA results.","definition_or_measurement_approach":"Safety and tolerability evaluated by incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), deaths, and standard clinical safety assessments (ECOG, vitals, labs, ECG, ECHO/MUGA)."}
{"endpoint_text":"- ORR is defined as the proportion of participants with a BOR of confirmed CR or confirmed PR according to RECIST v1.1.","definition_or_measurement_approach":"Objective response rate per RECIST v1.1; proportion of participants with confirmed complete response (CR) or partial response (PR)."}
{"endpoint_text":"- PFS is defined as the time interval from the date of randomization to the date of disease progression or death due to any cause. Disease progression will be determined by investigators’ assessment of tumor scans according to RECIST v1.1.","definition_or_measurement_approach":"Investigator-assessed PFS by RECIST v1.1 (time from randomization to progression or death)."}
{"endpoint_text":"- DoR is defined as the time from the date of first documentation of objective tumor response (CR or PR) for responding participants (CR or PR) only to the first documentation of objective tumor progression or death due to any cause.","definition_or_measurement_approach":"Duration of response measured from first documented response (CR/PR) until objective progression or death for responders."}
{"endpoint_text":"- TTR is defined as the time from the date of randomization to the date of the first documentation of objective response (CR or PR). Time to response will be measured for responding participants (CR or PR) only.","definition_or_measurement_approach":"Time to response measured from randomization to first documented CR or PR for responders."}
{"endpoint_text":"- PFS2 is defined as the time from the date of randomization to the first documented progression on next-line therapy or death due to any cause.","definition_or_measurement_approach":"Time from randomization to progression on next-line therapy or death."}
{"endpoint_text":"- Serum concentrations of T-DXd, total anti-HER2-antibody, and DXd.","definition_or_measurement_approach":"Pharmacokinetic measurements: serum concentration assays for T-DXd, total anti-HER2 antibody, and the DXd payload."}
{"endpoint_text":"- The proportion of participants having treatment-emergent ADA. Titer and neutralizing antibodies will be determined when ADA is positive.","definition_or_measurement_approach":"Immunogenicity: proportion with treatment-emergent anti-drug antibodies (ADA); titer and neutralizing antibody assessment if ADA positive."}
{"endpoint_text":"- Time to confirmed deterioration and change from baseline in the following measure: • FACT-GA subscale","definition_or_measurement_approach":"Patient-reported outcome: time to confirmed deterioration and change from baseline on FACT-GA subscale."}
{"endpoint_text":"- Time to confirmed deterioration and change from baseline in the following measure: • FACT-GA Physical Well-being subscale","definition_or_measurement_approach":"Patient-reported outcome: time to confirmed deterioration and change from baseline on FACT-GA Physical Well-being subscale."}
{"endpoint_text":"- Time to confirmed deterioration and change from baseline in the following measure: • EQ-5D-5L VAS","definition_or_measurement_approach":"Patient-reported outcome: time to confirmed deterioration and change from baseline in EQ-5D-5L visual analog scale (VAS)."}

Recruitment

Planned Sample Size: 726
Recruitment Window Months: 57
Consent Approach: Participants must sign and date the Tissue Prescreening ICF prior to HER2 and PD-L1 CPS central testing, the Main Screening ICF prior to trial-specific qualification procedures, and the Optional PGx ICF prior to PGx procedures. Only adults (≥18 years) are eligible; follow local regulations if the legal age for consent is >18. Multiple region/language-specific ICFs are provided (Main ICF, Tissue prescreening ICF, Optional PGx ICF, Pregnant Partner ICF, etc.). PRO questionnaires: participants unable to read the questionnaire (eg blind or illiterate) or where a language version is unavailable are exempted from completing PROs but may still participate.

Geography

Total Number Of Sites: 99
Total Number Of Participants: 214

Romania

Earliest CTIS Part Ii Submission Date: 16-01-2025
Latest Decision Or Authorization Date: 21-07-2025
Processing Time Days: 186
Number Of Sites: 8
Number Of Participants: 20

Sites

Site Name: Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name: Radioterapie
Contact Person Name: Alina Simona Muntean
Contact Person Email: muntean.alina@yahoo.fr

Site Name: Institutul Regional De Oncologie Iasi
Department Name: Oncologie medicala
Contact Person Name: Dana Elena Clement
Contact Person Email: dclement_6600@yahoo.com

Site Name: Sigmedical Services S.R.L.
Department Name: Oncologie medicala
Contact Person Name: Doina Elena Ganea
Contact Person Email: motan_doina@yahoo.com

Site Name: Medisprof S.R.L.
Department Name: Oncologie medicala
Contact Person Name: Anghel Adrian Udrea
Contact Person Email: adrianudrea@medisprof.ro

Site Name: Ovidius Clinical Hospital S.R.L.
Department Name: Oncologie medicala
Contact Person Name: Laura Mazilu
Contact Person Email: lauragrigorov@gmail.com

Site Name: Centrul De Oncologie SF Nectarie S.R.L.
Department Name: Oncologie medicala
Contact Person Name: Michael Schenker
Contact Person Email: mike_schenker@yahoo.com

Site Name: Institutul Clinic Fundeni
Department Name: Oncologie medicala
Contact Person Name: Adina Croitoru
Contact Person Email: adina.croitoru09@yahoo.com

Site Name: Centrul De Oncologie SF Nectarie S.R.L.
Department Name: Oncologie medicala
Contact Person Name: Michael Schenker
Contact Person Email: mike_schenker@yahoo.com

Austria

Earliest CTIS Part Ii Submission Date: 11-04-2025
Latest Decision Or Authorization Date: 06-05-2025
Processing Time Days: 25
Number Of Sites: 5
Number Of Participants: 11

Sites

Site Name: Medical University Of Graz
Department Name: Department of Oncology
Contact Person Name: Renate Schaberl Moser
Contact Person Email: renate.schaberl-moser@medunigraz.at

Site Name: St. Josef Krankenhaus GmbH
Department Name: Internal Medicine Department I and II
Contact Person Name: Leopold Oehler
Contact Person Email: leopold.oehler@sjk-wien.at

Site Name: Noe LGA Gesundheit Thermenregion GmbH
Department Name: Department of Internal Medicine, Hematology and Internal Oncology
Contact Person Name: Birgit Gruenberger
Contact Person Email: office@wienerneustadt.lknoe.at

Site Name: Medizinische Universitaet Innsbruck
Department Name: Department of Internal Medicine V
Contact Person Name: Arno Amann
Contact Person Email: arno.amann@tirol-kliniken.at

Site Name: Medical University Of Vienna
Department Name: Department of Medicine I, Divison of Oncology
Contact Person Name: Aysegül Ilhan-Mutlu
Contact Person Email: aysegul.ilhan@meduniwien.ac.at

Czechia

Earliest CTIS Part Ii Submission Date: 10-04-2025
Latest Decision Or Authorization Date: 30-04-2025
Processing Time Days: 20
Number Of Sites: 4
Number Of Participants: 16

Sites

Site Name: Masarykuv Onkologicky Ustav
Department Name: Klinika komplexní onkologické péče
Contact Person Name: Radka Lordick Obermannová
Contact Person Email: obermannova@mou.cz

Site Name: Fakultni Nemocnice Hradec Kralove
Department Name: Klinika onkologie a radioterapie
Contact Person Name: Milan Vošmik
Contact Person Email: milan.vosmik@fnhk.cz

Site Name: Fakultni Nemocnice V Motole
Department Name: Onkologická klinika
Contact Person Name: Stanislav Batko
Contact Person Email: stanislav.batko@fnmotol.cz

Site Name: University Hospital Olomouc
Department Name: Onkologická klinika
Contact Person Name: Bohuslav Melichar
Contact Person Email: bohuslav.melichar@fnol.cz

Italy

Earliest CTIS Part Ii Submission Date: 14-04-2025
Latest Decision Or Authorization Date: 30-04-2025
Processing Time Days: 16
Number Of Sites: 15
Number Of Participants: 25

Sites

Site Name: Humanitas Mirasole S.p.A.
Department Name: Oncology
Contact Person Name: Armando Santoro
Contact Person Email: armando.santoro@humanitas.it

Site Name: Casa Sollievo Della Sofferenza
Department Name: Medical Science
Contact Person Name: Maria Grazia Rodriquenz
Contact Person Email: mg.rodriquenz@gmail.com

Site Name: Azienda Unita Sanitaria Locale Della Romagna
Department Name: Oncology
Contact Person Name: Stefano Tamberi
Contact Person Email: stefano.tamberi@auslromagna.it

Site Name: IRCCS Ospedale Policlinico San Martino
Department Name: Oncology
Contact Person Name: Annamaria Pessino
Contact Person Email: Annamaria.pessino@hsanmartino.it

Site Name: ARNAS Garibaldi Di Catania
Department Name: Oncology
Contact Person Name: Roberto Bordonaro
Contact Person Email: rbordonaro@arnasgaribaldi.it

Site Name: Pia Fondazione Di Culto E Religione Card G Panico
Department Name: Oncology
Contact Person Name: Emiliano Tamburini
Contact Person Email: emilianotamburini@icloud.com

Site Name: Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name: Onocology
Contact Person Name: Filippo Pietrantonio
Contact Person Email: filippo.pietrantonio@istitutotumori.mi.it

Site Name: Azienda Ospedaliero Universitaria Di Modena
Department Name: Oncology
Contact Person Name: Andrea Spallanzani
Contact Person Email: spallanzani.andrea@aou.mo.it

Site Name: Istituto Oncologico Veneto
Department Name: Oncology
Contact Person Name: Sara Lonardi
Contact Person Email: sara.lonardi@iov.veneto.it

Site Name: Azienda Ospedaliero Universitaria Careggi
Department Name: Oncology
Contact Person Name: Lorenzo Antonuzzo
Contact Person Email: antonuzzol@aou-careggi.toscana.it

Site Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name: Oncology
Contact Person Name: Giampaolo Tortora
Contact Person Email: giampaolo.tortora@policlinicogemelli.it

Site Name: Azienda Ospedaliera Universitaria Pisana
Department Name: Oncology
Contact Person Name: Lorenzo Fornaro
Contact Person Email: Lorenzo.fornaro@gmail.com

Site Name: ASST Grande Ospedale Metropolitano Niguarda
Department Name: Oncology
Contact Person Name: Katia Bencardino
Contact Person Email: katiabruna.bencardino@ospedaleniguarda.it

Site Name: Azienda Ospedaliera Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name: Oncology
Contact Person Name: Ferdinando De Vita
Contact Person Email: ferdinando.devita@unicampania.it

Site Name: Ospedale San Raffaele S.r.l.
Department Name: Oncology
Contact Person Name: Silvia foti
Contact Person Email: silvia.foti@hsr.it

Germany

Earliest CTIS Part Ii Submission Date: 04-04-2025
Latest Decision Or Authorization Date: 02-05-2025
Processing Time Days: 28
Number Of Sites: 9
Number Of Participants: 10

Sites

Site Name: Universitaetsklinikum Heidelberg AöR
Department Name: NCT - Nationales Centrum für Tumorerkrankungen
Contact Person Name: Georg Martin Haag
Contact Person Email: GeorgMartin.Haag@med.uni-heidelberg.de

Site Name: Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name: Medizinische Klinik und Poliklinik I
Contact Person Name: Gunnar Folprecht
Contact Person Email: gunnar.folprecht@uniklinikum-dresden.de

Site Name: Vivantes Netzwerk fuer Gesundheit GmbH
Department Name: Klinik für Innere Medizin
Contact Person Name: Peter Thuß
Contact Person Email: Peter.thuss@vivantes.de

Site Name: Klinikum Chemnitz gGmbH
Department Name: Internal Medicine III
Contact Person Name: Jack Chater
Contact Person Email: j.chater@skc.de

Site Name: Universitaet Leipzig
Department Name: Universitäres Krebszentrum Leipzig (UCCL)
Contact Person Name: Florian Lordick
Contact Person Email: Lordick.Studienmails@medizin.uni-leipzig.de

Site Name: Haematologisch Onkologische Praxis Eppendorf / Norddeutsches Studienzentrum für Innovative Onkologie
Department Name: Hämatologisch Onkologische Praxis Eppendorf
Contact Person Name: Alexander Stein
Contact Person Email: stein@hope-hamburg.de

Site Name: Universitaetsklinikum Frankfurt AöR
Department Name: Medizinische Klinik I
Contact Person Name: Jörg Trojan
Contact Person Email: trojan@em.uni-frankfurt.de

Site Name: Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name: Dep. of Hematology and Oncology
Contact Person Name: Sylvie Lorenzen
Contact Person Email: sylvie.lorenzen@mri.tum.de

Site Name: Charité Campus Virchow-Klinikum
Department Name: Med. Klinik m.S. Hämatologie, Onkologie und Tumorimmunologie
Contact Person Name: Annika Kurreck
Contact Person Email: annika.kurreck@charite.de

Netherlands

Earliest CTIS Part Ii Submission Date: 14-04-2025
Latest Decision Or Authorization Date: 01-05-2025
Processing Time Days: 17
Number Of Sites: 5
Number Of Participants: 12

Sites

Site Name: Antoni van Leeuwenhoek Ziekenhuis
Department Name: Medical Oncology
Contact Person Name: Marieke Vollebergh
Contact Person Email: m.vollebergh@nki.nl

Site Name: Medisch Centrum Leeuwarden B.V.
Department Name: Medical Oncology
Contact Person Name: Joeri Douma
Contact Person Email: joeri.douma@mcl.nl

Site Name: Universitair Medisch Centrum Utrecht
Department Name: Medical Oncology
Contact Person Name: Nadia Haj Mohammad
Contact Person Email: n.hajmohammad@umcutrecht.nl

Site Name: Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name: Medical Oncology
Contact Person Name: Bianca Mostert
Contact Person Email: b.mostert@erasmusmc.nl

Site Name: Radboud universitair medisch centrum Stichting
Department Name: Medical Oncology
Contact Person Name: Harm Westdorp
Contact Person Email: Harm.Westdorp@radboudumc.nl

Belgium

Earliest CTIS Part Ii Submission Date: 09-04-2025
Latest Decision Or Authorization Date: 29-04-2025
Processing Time Days: 20
Number Of Sites: 6
Number Of Participants: 10

Sites

Site Name: Cliniques Universitaires Saint-Luc
Department Name: Medical Oncology
Contact Person Name: Marc Van den Eynde
Contact Person Email: marc.vandeneynde@saintluc.uclouvain.be

Site Name: Centre hospitalier universitaire de Liege
Department Name: Medical Oncology
Contact Person Name: Joëlle Collignon
Contact Person Email: joelle.collignon@chuliege.be

Site Name: Institut Jules Bordet
Department Name: Gastro-intestinal Medical Oncology
Contact Person Name: Ana-Maria Bucalau
Contact Person Email: ana-maria.bucalau@hubruxelles.be

Site Name: UZ Leuven
Department Name: Digestive Oncology
Contact Person Name: Filip Van Herpe
Contact Person Email: filip.vanherpe@uzleuven.be

Site Name: Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name: Oncology
Contact Person Name: Jean-Charles Goeminne
Contact Person Email: jean-charles.goeminne@chuuclnamur.uclouvain.be

Site Name: Az Sint-Lucas
Department Name: Gastroenterology
Contact Person Name: Annelies Holvoet
Contact Person Email: annelies.holvoet@stlucas.be

Norway

Earliest CTIS Part Ii Submission Date: 14-04-2025
Latest Decision Or Authorization Date: 05-05-2025
Processing Time Days: 21
Number Of Sites: 4
Number Of Participants: 9

Sites

Site Name: Helse Bergen HF
Department Name: Department of Oncology
Contact Person Name: Irene Matre Thowsen
Contact Person Email: irene.matre.thowsen@helse-bergen.no

Site Name: St. Olavs Hospital HF
Department Name: The Cancer Clinic
Contact Person Name: Ingunn Hatlevoll
Contact Person Email: ingunn.hatlevoll@stolav.no

Site Name: Oslo University Hospital HF
Department Name: The Cancer Center
Contact Person Name: Ghazwan Al-Haidari
Contact Person Email: ghazal@ous-hf.no

Site Name: Akershus University Hospital
Department Name: Department of Oncology
Contact Person Name: Åsa Dahle Smith
Contact Person Email: asa.dahle.smith@ahus.no

France

Earliest CTIS Part Ii Submission Date: 17-04-2025
Latest Decision Or Authorization Date: 06-05-2025
Processing Time Days: 19
Number Of Sites: 16
Number Of Participants: 32

Sites

Site Name: Centre Regional Lutte Contre Le Cancer
Department Name: Medical Oncology
Contact Person Name: Meher BEN ABDELGHANI
Contact Person Email: m.ben-abdelghani@icans.eu

Site Name: Centre Hospitalier Universitaire De Montpellier
Department Name: Medical Oncology
Contact Person Name: Eric ASSENAT
Contact Person Email: e-assenat@chu-montpellier.fr

Site Name: Assistance Publique Hopitaux De Paris
Department Name: Digestive Oncology
Contact Person Name: Aziz ZAANAN
Contact Person Email: aziz.zaanan@aphp.fr

Site Name: Centr Georges Francois Leclerc
Department Name: Medical Oncology
Contact Person Name: François GHIRINGHELLI
Contact Person Email: fghiringhelli@cgfl.fr

Site Name: Centre Hospitalier Universitaire De Bordeaux
Department Name: Digestive Oncology
Contact Person Name: Eric TERREBONNE
Contact Person Email: eric.terrebonne@chu-bordeaux.fr

Site Name: Centre Hospitalier Universitaire Grenoble Alpes
Department Name: Hepato-gastroenterology
Contact Person Name: Victoire GRANGER
Contact Person Email: VGranger@chu-grenoble.fr

Site Name: Institut Mutualiste Montsouris
Department Name: Medical Oncology
Contact Person Name: David MALKA
Contact Person Email: david.malka@imm.fr

Site Name: Hopital Saint Antoine
Department Name: Medical Oncology
Contact Person Name: Romain COHEN
Contact Person Email: romain.cohen@aphp.fr

Site Name: Centre Hospitalier Universitaire De Toulouse
Department Name: Medical Oncology
Contact Person Name: Rosine GUIMBAUD
Contact Person Email: guimbaud.r@chu-toulouse.fr

Site Name: Hopital Prive Jean Mermoz
Department Name: Gastroenterology and gastrointestinal oncology
Contact Person Name: Pascal ARTRU
Contact Person Email: dr.artru@wanadoo.fr

Site Name: Centre Hospitalier Universitaire De Nantes
Department Name: Medical Oncology
Contact Person Name: Juliette BOILEVE
Contact Person Email: juliette.boileve@chu-nantes.fr

Site Name: Centre Hospitalier Universitaire De Poitiers
Department Name: Gastroenterology and medical oncology
Contact Person Name: David TOUGERON
Contact Person Email: david.tougeron@chu-poitiers.fr

Site Name: Centre Oscar Lambret
Department Name: Oncology
Contact Person Name: Diane PANNIER
Contact Person Email: d-pannier@o-lambret.fr

Site Name: Sainte Catherine Institut Du Cancer Avignon-Provence
Department Name: Oncology-Radiotherapy
Contact Person Name: Laurent MINEUR
Contact Person Email: l.mineur@isc84.org

Site Name: Hospital Foch
Department Name: Medical Oncology
Contact Person Name: Jaafar BENNOUNA
Contact Person Email: j.bennouna@hopital-foch.com

Site Name: Centre Hospitalier Regional Et Universitaire De Brest
Department Name: Oncology
Contact Person Name: Jean-Philippe METGES
Contact Person Email: jean-philippe.metges@chu-brest.fr

Portugal

Earliest CTIS Part Ii Submission Date: 05-03-2025
Latest Decision Or Authorization Date: 30-04-2025
Processing Time Days: 56
Number Of Sites: 6
Number Of Participants: 15

Sites

Site Name: Unidade Local De Saude De Santa Maria E.P.E.
Department Name: Oncology
Contact Person Name: Catarina Abreu
Contact Person Email: catarinaabreupm@gmail.com

Site Name: Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name: Medical Oncology Service
Contact Person Name: Cátia Faustino
Contact Person Email: catia.faustino@ipoporto.min-saude.pt

Site Name: Hospital Da Luz S.A.
Department Name: Oncology
Contact Person Name: Tânia Rodrigues
Contact Person Email: trodrigues@hospitaldaluz.pt

Site Name: Champalimaud Clinical Centre
Department Name: Digestive Unit
Contact Person Name: Nuno Couto
Contact Person Email: nuno.couto@fundacaochampalimaud.pt

Site Name: Unidade Local De Saude Do Alto Ave E.P.E.
Department Name: Oncology service
Contact Person Name: Ilda Faustino
Contact Person Email: idetus@gmail.com

Site Name: CCAB Centro Clinico Academico Braga Associacao
Department Name: Medical Oncology Service
Contact Person Name: Ana Daniela Marques
Contact Person Email: ana.daniela.marques@hb.min-saude.pt

Poland

Earliest CTIS Part Ii Submission Date: 17-04-2025
Latest Decision Or Authorization Date: 05-05-2025
Processing Time Days: 18
Number Of Sites: 5
Number Of Participants: 9

Sites

Site Name: Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name: Klinika Onkologii i Radioterapii
Contact Person Name: Lucjan Wyrwicz
Contact Person Email: lucjan.wyrwicz@nio.gov.pl

Site Name: Beskidzkie Centrum Onkologii Szpital Miejski Im. Jana Pawla II W Bielsku-Bialej SPZOZ
Department Name: Katedra i Klinika Onkologii
Contact Person Name: Rafał Wiśniowski
Contact Person Email: wiraf@poczta.onet.pl

Site Name: Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name: Oddział Dzienny Chemioterapii
Contact Person Name: Mariusz Kwiatkowski
Contact Person Email: sekretariat.odch@swk.med.pl

Site Name: Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Department Name: Oddział Onkologii Klinicznej i Immunoonkologii z Pododziałem Dziennym i Izbą Przyjęć
Contact Person Name: Ewa Prochowska- Mróz
Contact Person Email: ewa.prochowska@wco.pl

Site Name: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Department Name: Oddział Kliniczny Onkologii
Contact Person Name: Rafał Stec
Contact Person Email: onkologia.csk@uckwum.pl

Spain

Earliest CTIS Part Ii Submission Date: 04-04-2025
Latest Decision Or Authorization Date: 30-04-2025
Processing Time Days: 26
Number Of Sites: 16
Number Of Participants: 45

Sites

Site Name: Hospital Clinico Universitario De Valencia
Department Name: Medical oncology
Contact Person Name: Tania Fleitas Kanonnikoff
Contact Person Email: tfleitas@incliva.es

Site Name: University Hospital Virgen Del Rocio S.L.
Department Name: Medical Oncology
Contact Person Name: MAría Luisa Limón Mirón
Contact Person Email: mluisalimon@gmail.com

Site Name: Hospital General Universitario De Elche
Department Name: Medical oncology
Contact Person Name: Javier Gallego Plazas
Contact Person Email: j.gallegoplazas@gmail.com

Site Name: Hospital Del Mar
Department Name: Medical oncology
Contact Person Name: Laura Visa Turmo
Contact Person Email: lvisa@psmar.cat

Site Name: Hospital Universitario Central De Asturias
Department Name: Medical oncology
Contact Person Name: Paula Jiménez Fonseca
Contact Person Email: palucaji@hotmail.com

Site Name: Hospital General Universitario Gregorio Maranon
Department Name: Medical Oncology
Contact Person Name: Aitana Calvo Ferrandis
Contact Person Email: aitanacalvo@hotmail.com

Site Name: Hospital Clinic De Barcelona
Department Name: Medical oncology
Contact Person Name: Tamara Saurí Nadal
Contact Person Email: sauri@clinic.cat

Site Name: Hospital Universitario Reina Sofia
Department Name: Medical Oncology
Contact Person Name: Raquel Serrano Blanch
Contact Person Email: rsblanch@hotmail.com

Site Name: Institut Catala D'oncologia (Badalona)
Department Name: Medical oncology
Contact Person Name: Cristina Bugés Sánchez
Contact Person Email: cbuges@iconcologia.net

Site Name: Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name: Medical oncology
Contact Person Name: Mariona Calvo Campos
Contact Person Email: mcalvo@iconcologia.net

Site Name: MD Anderson Cancer Center
Department Name: Medical Oncology
Contact Person Name: José Ignacio Martín Valadés
Contact Person Email: jose.martinv@mdanderson.es

Site Name: Hospital General Universitario Morales Meseguer
Department Name: Medical Oncology
Contact Person Name: Alberto Carmona Bayonas
Contact Person Email: alberto.carmonabayonas@gmail.com

Site Name: Hospital Universitario De Navarra
Department Name: Medical Oncology
Contact Person Name: María Alsina Maqueda
Contact Person Email: maria.alsina.maqueda@navarra.es

Site Name: Hospital Universitari Vall D Hebron
Department Name: Medical oncology
Contact Person Name: Daniel Alejandro Acosta Eyzaguirre
Contact Person Email: dacosta@vhio.net

Site Name: Hospital Universitario Ramon Y Cajal
Department Name: Medical Oncology
Contact Person Name: Federico Longo Muñoz
Contact Person Email: federico.longo@salud.madrid.org

Site Name: Hospital Universitario Regional De Malaga
Department Name: Medical Oncology
Contact Person Name: Carolina Muriel López
Contact Person Email: carolinamuriellopez@hotmail.com

Sponsor

Primary sponsor

Full Name: Daiichi Sankyo Inc.
Organisation Type: Pharmaceutical company
Country Of Registered Address: United States

Contract research organisations

Name: IQVIA Limited
Responsibilities: Full CRO support / multiple sponsor duties codes: [1,12,13,2,5,8]; contact: eu_clinical_trials_information@iqvia.com

Name: PPD Development LP
Responsibilities: PK/ADA Lab (sponsorDuties code: 15); contact: Cheri.carver@ppd.com

Name: Fortrea Inc.
Responsibilities: Sponsor duties code: [6]; contact: robin.martin@fortrea.com

Name: Medidata Solutions Inc.
Responsibilities: Electronic data systems (sponsorDuties code: 7); contact: info@medidata.com

Name: Bioclinica Inc.
Responsibilities: Central Imaging (sponsorDuties code: 15); contact: support@bioclinica.com

Name: Labcorp Central Laboratory Services SARL
Responsibilities: Laboratory services (sponsorDuties code: 4); contact: ctasubmissions@labcorp.com

Third parties

{"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Non-Pharmaceutical company"}
{"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Non-Pharmaceutical company"}
{"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"ctDNA (sponsorDuties code: 15, value: ctDNA)","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Agilent Technologies, Inc.","duties_or_roles":"KIT and manufacturer for PD-L1 and HER-2 testing (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"e-COA (sponsorDuties code: 15, value: e-COA)","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: [1,12,13,2,5,8]","organisation_type":"Pharmaceutical company"}
{"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Fisher Bioservices Inc.","duties_or_roles":"Sample Long-term storage (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Imaging (sponsorDuties code: 15)","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United States","full_name":"PPD Development LP","duties_or_roles":"PK/ADA Lab (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
{"country":"Ireland","full_name":"Teckro Limited","duties_or_roles":"Site Engagement platform (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Data/Electronic systems (contact email: info@medidata.com)","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name: DS-8201a
Active Substance: TRASTUZUMAB DERUXTECAN
Modality: ADC
Routes Of Administration: INTRAVENOUS INJECTION
Route: INTRAVENOUS INJECTION
Authorisation Status: prodAuthStatus 1 (investigational/unlicensed)
Maximum Dose: 5.4 mg/kg

Investigational Product Name: Herzuma 150 mg powder for concentrate for solution for infusion
Active Substance: TRASTUZUMAB
Modality: Monoclonal antibody
Routes Of Administration: INTRAVENOUS INJECTION
Route: INTRAVENOUS INJECTION
Authorisation Status: prodAuthStatus 2 (authorised)
Maximum Dose: 8 mg/kg (maxDailyDoseAmount field)

Investigational Product Name: KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance: PEMBROLIZUMAB
Modality: Monoclonal antibody
Routes Of Administration: INTRAVENOUS INJECTION
Route: INTRAVENOUS INJECTION
Authorisation Status: prodAuthStatus 2 (authorised)
Maximum Dose: 200 mg (maxDailyDoseAmount field)

Investigational Product Name: CAPECITABINE
Active Substance: CAPECITABINE
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: prodAuthStatus 2 (authorised/specified as comparator)
Maximum Dose: 2000 mg/m2 (maxDailyDoseAmount field)

Investigational Product Name: 5-Fluorouracil Ebewe 50 mg/ml
Active Substance: FLUOROURACIL
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INJECTION
Route: INTRAVENOUS INJECTION
Authorisation Status: prodAuthStatus 2 (authorised)
Maximum Dose: 800 mg/m2 (maxDailyDoseAmount field)

Investigational Product Name: Cisplatin Hikma 1 mg/ml
Active Substance: CISPLATIN
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INJECTION
Route: INTRAVENOUS INJECTION
Authorisation Status: prodAuthStatus 2 (authorised)
Maximum Dose: 80 mg/m2 (maxDailyDoseAmount field)

Investigational Product Name: Oxaliplatin AqVida 5 mg/ml
Active Substance: OXALIPLATIN
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INJECTION
Route: INTRAVENOUS INJECTION
Authorisation Status: prodAuthStatus 2 (authorised)
Maximum Dose: 130 mg/m2 (maxDailyDoseAmount field)

Combination Treatment: Yes

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