Clinical trial • Phase III • Oncology
TRASTUZUMAB DERUXTECAN for Non-small cell lung cancer with HER2 exon 19 or 20 mutations
Phase III trial of TRASTUZUMAB DERUXTECAN for Non-small cell lung cancer with HER2 exon 19 or 20 mutations.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer with HER2 exon 19 or 20 mutations
- Trial Stage
- Phase III
- Drug Modality
- ADC|Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 13-06-2024
- First CTIS Authorization Date
- 11-07-2024
Trial design
Randomised, open-label, cisplatin or carboplatin with pemetrexed and pembrolizumab (platinum doublet chemotherapy with pemetrexed plus pembrolizumab); dosing and schedule not specified in ctis record.-controlled Phase III trial in Denmark, Germany, France and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Cisplatin or carboplatin with pemetrexed and pembrolizumab (platinum doublet chemotherapy with pemetrexed plus pembrolizumab); dosing and schedule not specified in CTIS record.
- Target Sample Size
- 290
Eligibility
Recruits 290 Vulnerable population selected. Informed consent obtained via subject information and informed consent forms. Country-specific ICFs and participant documents are provided (including adult ICFs and specific ICFs for pregnant partners, genetic research, pre-screening and future research) in multiple country/language versions..
- Vulnerable Population
- Vulnerable population selected. Informed consent obtained via subject information and informed consent forms. Country-specific ICFs and participant documents are provided (including adult ICFs and specific ICFs for pregnant partners, genetic research, pre-screening and future research) in multiple country/language versions.
Inclusion criteria
- {"criterion_text":"- Male and female participants at least 18 years of age\n- Locally advanced not amenable to curative therapy, or metastatic disease\n- Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA (locally or centrally tested)\n- Treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease\n- Left ventricular ejection fraction (LVEF) ≥ 50%\n- Measurable disease assessed by Investigator based on RECIST v1.1\n- Protocol-defined adequate organ function including cardiac, renal, hepatic function\n- ECOG 0-1\n- Having tumour tissue available for central testing"}
Exclusion criteria
- {"criterion_text":"- Tumors with targetable alterations to EGFR (or other targetable mutations including but not limited to ALK, if routinely tested as a targetable alteration with approved available therapy)\n- Clinically active brain metastases, defined as untreated AND/OR symptomatic, or requiring therapy to control associated symptoms. All participants with brain metastases must have previously completed local therapy.\n- Active autoimmune or inflammatory disorders\n- Medical history of myocardial infarction within 6 months prior to randomization\n- History of non-infectious pneumonitis/ILD, current or suspected ILD\n- Lung-specific intercurrent clinical significant severe illness\n- Contraindication to platinum-based doublet chemotherapy or pembrolizumab"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression Free Survival (PFS) defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR) or death due to any cause.","definition_or_measurement_approach":"PFS defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR) or death due to any cause."}
Secondary endpoints
- {"endpoint_text":"- 1. Overall Survival (OS) defined as time from randomization until date of death due to any cause.","definition_or_measurement_approach":"OS defined as time from randomization until date of death due to any cause."}
- {"endpoint_text":"- 2-1: PFS by investigator assessment defined as time from randomization until progression as assessed by investigator (per RECIST 1.1) or death due to any cause. Objective Response Rate (ORR) and Duration of Response (DoR) by BICR and Investigator assessment per RECIST 1.1. ORR is defined as proportion of participants who have a complete response (CR) or partial response (PR).","definition_or_measurement_approach":"PFS by investigator per RECIST 1.1; ORR defined as proportion with CR or PR; DoR measured by time from first documented response to progression. Assessed by BICR and investigator."}
- {"endpoint_text":"- 2-2: DoR is defined as time from date of first documented response until date of documented progression. PFS2 is defined as time from randomization to second progression on next-line of treatment as assessed by investigator or death due to any cause.","definition_or_measurement_approach":"DoR: time from first documented response to documented progression. PFS2: time from randomization to second progression on next-line treatment or death; investigator-assessed."}
- {"endpoint_text":"- 2-3: PFS12 is the landmark of PFS which is defined as proportion of participants alive and progression-free at 12 months as assessed by BICR and investigator. OS24 is the landmark of OS defined as proportion of patients alive at 24 months","definition_or_measurement_approach":"PFS12: proportion alive and progression-free at 12 months by BICR and investigator; OS24: proportion alive at 24 months."}
- {"endpoint_text":"- 3. CNS-PFS defined as time from randomization until CNS-progression (RECIST 1.1) as assessed by BICR or death due to any cause in absence of CNS progression.","definition_or_measurement_approach":"CNS-PFS: time from randomization to CNS progression per RECIST 1.1 by BICR or death absent CNS progression."}
- {"endpoint_text":"- 4. AEs, SAEs, changes from baseline in laboratory parameters, vital signs, ECG, ECHO/MUGA results.","definition_or_measurement_approach":"Safety and tolerability assessed via adverse events (AEs), serious adverse events (SAEs), lab parameter changes, vital signs, ECG, and ECHO/MUGA."}
- {"endpoint_text":"- 5. Pharmacokinetics (PK) of T-DXd and serum concentration of T-DXd, total anti-HER2 antibody and DXd","definition_or_measurement_approach":"PK measures of T-DXd and serum concentrations of T-DXd, total anti-HER2 antibody and DXd."}
- {"endpoint_text":"- 6. Presence of ADAs for T-DXd","definition_or_measurement_approach":"Assessment of anti-drug antibodies (ADAs) for T-DXd in serum."}
- {"endpoint_text":"- 7. Time to sustained deterioration in pulmonary symptoms while on treatment using NSCLC-Symptom Assessment Questionnaire (SAQ)","definition_or_measurement_approach":"Time to sustained deterioration measured by NSCLC-SAQ patient-reported outcomes."}
- {"endpoint_text":"- 8. Patient Reported Tolerability will be described among participants using the following outcomes: Symptomatic AEs (assessed by PROCTCAE and EORTC Item Library), Overall Side Effect Bother (reported on Patient's Global Impression of Treatment Tolerability (PGI-TT)), Physical Function (based on EORTC-QLQ-30)","definition_or_measurement_approach":"Patient-reported tolerability assessed via PRO-CTCAE, EORTC Item Library, PGI-TT, and EORTC-QLQ-30 physical function scores."}
Recruitment
- Planned Sample Size
- 290
- Recruitment Window Months
- 33
- Consent Approach
- Informed consent obtained from adult participants (≥18) via subject information and informed consent forms. Country-specific ICFs are provided in multiple languages and for specific situations (e.g., pregnant partner ICF, genetic research, pre-screening, optional future research).
Geography
- Total Number Of Sites
- 38
- Total Number Of Participants
- 160
Denmark
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 13-02-2026
- Processing Time Days
- 597
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Lillebaelt Hospital
- Department Name
- Onkologis Afdeling
- Principal Investigator Name
- Christa Nyhus
- Principal Investigator Email
- Christa.Haugaard.Nyhus@rsyd.dk
- Contact Person Name
- Christa Nyhus
- Contact Person Email
- Christa.Haugaard.Nyhus@rsyd.dk
Germany
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 18-02-2026
- Processing Time Days
- 602
- Number Of Sites
- 5
- Number Of Participants
- 9
Sites
- Site Name
- Ludwig-Maximilians-Universitaet Muenchen
- Department Name
- Med. V, Pneumologie
- Principal Investigator Name
- Amanda Tufman
- Principal Investigator Email
- amanda.tufman@med.uni-muenchen.de
- Contact Person Name
- Amanda Tufman
- Contact Person Email
- amanda.tufman@med.uni-muenchen.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Centrum für integrierte Onkologie
- Principal Investigator Name
- Matthias Scheffler
- Principal Investigator Email
- Matthias.scheffler@uk-koeln.de
- Contact Person Name
- Matthias Scheffler
- Contact Person Email
- Matthias.scheffler@uk-koeln.de
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Medizinische Klinik und Poliklinik I
- Principal Investigator Name
- Martin Wermke
- Principal Investigator Email
- martin.wermke@uniklinikum-dresden.de
- Contact Person Name
- Martin Wermke
- Contact Person Email
- martin.wermke@uniklinikum-dresden.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- III. Medizinische Klinik und Poliklinik
- Principal Investigator Name
- Juergen Alt
- Principal Investigator Email
- juergen.alt@unimedizin-mainz.de
- Contact Person Name
- Juergen Alt
- Contact Person Email
- juergen.alt@unimedizin-mainz.de
- Site Name
- Pius-Hospital Oldenburg
- Department Name
- Internistische Onkologie
- Principal Investigator Name
- Frank Griessinger
- Principal Investigator Email
- frank.griesinger@pius-hospital.de
- Contact Person Name
- Frank Griessinger
- Contact Person Email
- frank.griesinger@pius-hospital.de
France
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 18-02-2026
- Processing Time Days
- 602
- Number Of Sites
- 8
- Number Of Participants
- 36
Sites
- Site Name
- CHU De Bordeauxt
- Department Name
- Département d'oncologie médicale
- Principal Investigator Name
- Charlotte Domblides
- Principal Investigator Email
- charlotte.domblides@chu-bordeaux.fr
- Contact Person Name
- Charlotte Domblides
- Contact Person Email
- charlotte.domblides@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Service oncologie multidisciplinaire et innovations thérapeutiques
- Principal Investigator Name
- Pascale Tomasini
- Principal Investigator Email
- pascale.tomasini@ap-hm.fr
- Contact Person Name
- Pascale Tomasini
- Contact Person Email
- pascale.tomasini@ap-hm.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Département d'oncologie médicale - Groupe Thoracique
- Principal Investigator Name
- David Planchard
- Principal Investigator Email
- david.planchard@gustaveroussy.fr
- Contact Person Name
- David Planchard
- Contact Person Email
- david.planchard@gustaveroussy.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service oncologie thoracique
- Principal Investigator Name
- Elvire Pons
- Principal Investigator Email
- elvire.pons@chu-nantes.fr
- Contact Person Name
- Elvire Pons
- Contact Person Email
- elvire.pons@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Service de Pneumologie
- Principal Investigator Name
- Julien Mazières
- Principal Investigator Email
- mazieres.j@chu-toulouse.fr
- Contact Person Name
- Julien Mazières
- Contact Person Email
- mazieres.j@chu-toulouse.fr
- Site Name
- Centre Leon Berard
- Department Name
- Service d'oncologie médicale - oncologie thoracique
- Principal Investigator Name
- Maurice Perol
- Principal Investigator Email
- maurice.perol@lyon.unicancer.fr
- Contact Person Name
- Maurice Perol
- Contact Person Email
- maurice.perol@lyon.unicancer.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Département d'oncologie médicale
- Principal Investigator Name
- Laure Favier
- Principal Investigator Email
- lfavier@cgfl.fr
- Contact Person Name
- Laure Favier
- Contact Person Email
- lfavier@cgfl.fr
- Site Name
- Centre Hospitalier Le Mans
- Department Name
- Pneumologie et Oncologie Thoracique
- Principal Investigator Name
- Olivier Molinier
- Principal Investigator Email
- o.molinier@ch-lemans.fr
- Contact Person Name
- Olivier Molinier
- Contact Person Email
- o.molinier@ch-lemans.fr
Austria
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 17-02-2026
- Processing Time Days
- 601
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Univ.-Klinik für Innere Medizin V
- Principal Investigator Name
- Andreas Pircher
- Principal Investigator Email
- Andreas.pircher@tirol-kliniken.at
- Contact Person Name
- Andreas Pircher
- Contact Person Email
- Andreas.pircher@tirol-kliniken.at
- Site Name
- Ordensklinikum Linz GmbH
- Department Name
- Servicestelle für klinische Studien Pneumologie 2, 2B
- Principal Investigator Name
- Michael Schumacher
- Principal Investigator Email
- michael.schumacher@ordensklinikum.at
- Contact Person Name
- Michael Schumacher
- Contact Person Email
- michael.schumacher@ordensklinikum.at
- Site Name
- Stadt Wien Wiener Gesundheitsverbund
- Department Name
- Abteilung für Innere Medizin und Pneumologie
- Principal Investigator Name
- Maximilian Hochmair
- Principal Investigator Email
- maximilian.hochmair@gesundheitsverbund.at
- Contact Person Name
- Maximilian Hochmair
- Contact Person Email
- maximilian.hochmair@gesundheitsverbund.at
Spain
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 17-02-2026
- Processing Time Days
- 601
- Number Of Sites
- 4
- Number Of Participants
- 26
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Luis Paz-Ares Rodriguez
- Principal Investigator Email
- lpazaresr@seom.org
- Contact Person Name
- Luis Paz-Ares Rodriguez
- Contact Person Email
- lpazaresr@seom.org
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Alexandra Cantero Gonzalez
- Principal Investigator Email
- alexandra.cantero@uma.es
- Contact Person Name
- Alexandra Cantero Gonzalez
- Contact Person Email
- alexandra.cantero@uma.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Oscar Juan Vidal
- Principal Investigator Email
- juan_osc@gva.es
- Contact Person Name
- Oscar Juan Vidal
- Contact Person Email
- juan_osc@gva.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Ernest Nadal Alforja
- Principal Investigator Email
- esnadal@iconcologia.net
- Contact Person Name
- Ernest Nadal Alforja
- Contact Person Email
- esnadal@iconcologia.net
Poland
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 600
- Number Of Sites
- 5
- Number Of Participants
- 3
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworów Pluca i Klatki Piersiowej
- Principal Investigator Name
- Dariusz Kowalski
- Principal Investigator Email
- dariusz.kowalski@nio.gov.pl
- Contact Person Name
- Dariusz Kowalski
- Contact Person Email
- dariusz.kowalski@nio.gov.pl
- Site Name
- Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
- Department Name
- Oddzial Onkologiczny z Pododdziałem Dziennej Chemioterapii
- Principal Investigator Name
- Kamil Kuc
- Principal Investigator Email
- kkuc@wszp.pl
- Contact Person Name
- Kamil Kuc
- Contact Person Email
- kkuc@wszp.pl
- Site Name
- Centrum Pulmonologii I Torakochirurgii W Bystrej
- Department Name
- Oddzial Pulmonologiczno-Onkologiczny z Chemioterapia
- Principal Investigator Name
- Adrianna Gega-Czarnota
- Principal Investigator Email
- Adrianna.gega@gmail.com
- Contact Person Name
- Adrianna Gega-Czarnota
- Contact Person Email
- Adrianna.gega@gmail.com
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Onkologii i Radioterapii
- Principal Investigator Name
- Rafal Dziadziuszko
- Principal Investigator Email
- rafald@gumed.edu.pl
- Contact Person Name
- Rafal Dziadziuszko
- Contact Person Email
- rafald@gumed.edu.pl
- Site Name
- Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
- Department Name
- Oddzial Onkologii z Pododdziałem Chemioterapii
- Principal Investigator Name
- Jarosław Kolb-Sielecki
- Principal Investigator Email
- j.kolbsielecki@gmail.com
- Contact Person Name
- Jarosław Kolb-Sielecki
- Contact Person Email
- j.kolbsielecki@gmail.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 600
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Pneumology
- Principal Investigator Name
- Veerle Surmont
- Principal Investigator Email
- veerle.surmont@uzgent.be
- Contact Person Name
- Veerle Surmont
- Contact Person Email
- veerle.surmont@uzgent.be
- Site Name
- Jessa Ziekenhuis
- Department Name
- Pneumology
- Principal Investigator Name
- Kristof Cuppens
- Principal Investigator Email
- Kristof.Cuppens@jessazh.be
- Contact Person Name
- Kristof Cuppens
- Contact Person Email
- Kristof.Cuppens@jessazh.be
- Site Name
- UZ Leuven
- Department Name
- Respiratory diseases
- Principal Investigator Name
- Christophe Dooms
- Principal Investigator Email
- christophe.dooms@uzleuven.be
- Contact Person Name
- Christophe Dooms
- Contact Person Email
- christophe.dooms@uzleuven.be
Netherlands
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 600
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Radboud universitair medisch centrum / RADBOUDUMC
- Department Name
- Pulmonary Diseases
- Principal Investigator Name
- Chantal Smits
- Principal Investigator Email
- chantal.smits-vandergraaf@radboudumc.nl
- Contact Person Name
- Chantal Smits
- Contact Person Email
- chantal.smits-vandergraaf@radboudumc.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Pulmonary Oncology
- Principal Investigator Name
- Anthonie van der Wekken
- Principal Investigator Email
- a.j.van.der.wekken@umcg.nl
- Contact Person Name
- Anthonie van der Wekken
- Contact Person Email
- a.j.van.der.wekken@umcg.nl
- Site Name
- VUmc Stichting
- Department Name
- Pulmonary Disease
- Principal Investigator Name
- Sayed Hashemi
- Principal Investigator Email
- s.hashemi@amsterdamumc.nl
- Contact Person Name
- Sayed Hashemi
- Contact Person Email
- s.hashemi@amsterdamumc.nl
Italy
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 17-02-2026
- Processing Time Days
- 601
- Number Of Sites
- 6
- Number Of Participants
- 50
Sites
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Principal Investigator Name
- Silvia Novello
- Principal Investigator Email
- silvia.novello@unito.it
- Contact Person Name
- Silvia Novello
- Contact Person Email
- silvia.novello@unito.it
- Site Name
- Azienda Ospedaliero Universitaria Parma
- Principal Investigator Name
- Marcello Tiseo
- Principal Investigator Email
- mtiseo@ao.pr.it
- Contact Person Name
- Marcello Tiseo
- Contact Person Email
- mtiseo@ao.pr.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Principal Investigator Name
- Sara Pilotto
- Principal Investigator Email
- sara.pilotto@univr.it
- Contact Person Name
- Sara Pilotto
- Contact Person Email
- sara.pilotto@univr.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Principal Investigator Name
- Filippo De Marinis
- Principal Investigator Email
- filippo.demarinis@ieo.it
- Contact Person Name
- Filippo De Marinis
- Contact Person Email
- filippo.demarinis@ieo.it
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Principal Investigator Name
- Diego Luigi Cortinovis
- Principal Investigator Email
- d.cortinovis@hsgerardo.org
- Contact Person Name
- Diego Luigi Cortinovis
- Contact Person Email
- d.cortinovis@hsgerardo.org
- Site Name
- Universita Cattolica Del Sacro Cuore
- Principal Investigator Name
- Emilio Bria
- Principal Investigator Email
- emilio.bria@policlinicogemelli.it
- Contact Person Name
- Emilio Bria
- Contact Person Email
- emilio.bria@policlinicogemelli.it
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Third parties
- {"country":"Denmark","full_name":"Astrazeneca A/S","duties_or_roles":"Sponsor duties code: 1","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- DS-8201a
- Active Substance
- TRASTUZUMAB DERUXTECAN
- Modality
- ADC
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- prodAuthStatus: 1
- Investigational Product Name
- PEMBROLIZUMAB
- Active Substance
- PEMBROLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- prodAuthStatus: 2
- Investigational Product Name
- CISPLATIN
- Active Substance
- CISPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- prodAuthStatus: 2
- Investigational Product Name
- CARBOPLATIN
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- prodAuthStatus: 2
- Investigational Product Name
- PEMETREXED
- Active Substance
- PEMETREXED
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- prodAuthStatus: 2
- Combination Treatment
- Yes
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