Clinical trial • Phase I • Oncology
zongertinib for Non-small cell lung cancer | Solid tumours with HER2 aberrations
Phase I trial of zongertinib for Non-small cell lung cancer | Solid tumours with HER2 aberrations. adaptive. 430 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer | Solid tumours with HER2 aberrations
- Trial Stage
- Phase I
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 03-09-2024
- First CTIS Authorization Date
- 25-09-2024
Trial design
adaptive Phase I trial across 27 sites in Spain, Netherlands, Belgium and others.
- Adaptive
- True, dose-finding / dose-escalation elements (study title: "A study to test different doses of zongertinib" indicate testing different dose levels)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 430
Recruitment
- Planned Sample Size
- 430
- Recruitment Window Months
- 55
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 162
Spain
- Earliest CTIS Part Ii Submission Date
- 19-09-2024
- Latest Decision Or Authorization Date
- 20-10-2025
- Processing Time Days
- 396
- Number Of Sites
- 7
- Number Of Participants
- 33
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Servicio de Oncología
- Contact Person Name
- Jon Zugazagoitia
- Contact Person Email
- j.zugazagoitia.imas12@h12o.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de Oncología Médica
- Contact Person Name
- Enriqueta Felip
- Contact Person Email
- efelip@vhio.net
- Site Name
- Institut Catala D'oncologia
- Department Name
- Department of Medical Oncology
- Contact Person Name
- Ernest Nadal Alforja
- Contact Person Email
- esnadal@iconcologia.net
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- UGC Oncología Intercentros
- Contact Person Name
- Javier García Corbacho
- Contact Person Email
- jgcorbacho@ibima.eu
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Servicio de Hematología y Oncología
- Contact Person Name
- Valentina Gambardella
- Contact Person Email
- valen.gambardella@gmail.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Thoracic Oncology, Head & Neck and Sarcoma Unit
- Contact Person Name
- Antonio Calles Blanco
- Contact Person Email
- antonio.calles@live.com
- Site Name
- Hospital Universitario 12 De Octubre
Netherlands
- Earliest CTIS Part Ii Submission Date
- 19-09-2024
- Latest Decision Or Authorization Date
- 08-10-2025
- Processing Time Days
- 384
- Number Of Sites
- 2
- Number Of Participants
- 71
Sites
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Klinische Farmacologie
- Contact Person Name
- Gerrina Ruiter
- Contact Person Email
- g.ruiter@nki.nl
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Longziekten
- Contact Person Name
- Egbert Smit
- Contact Person Email
- e.f.smit@LUMC.nl
Belgium
- Earliest CTIS Part Ii Submission Date
- 19-09-2024
- Latest Decision Or Authorization Date
- 11-08-2025
- Processing Time Days
- 326
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Institut Jules Bordet
- Department Name
- Oncology department
- Contact Person Name
- Mariana Brandao
- Contact Person Email
- mariana.brandao@hubruxelles.be
Germany
- Earliest CTIS Part Ii Submission Date
- 19-09-2024
- Latest Decision Or Authorization Date
- 08-10-2025
- Processing Time Days
- 384
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- Justus-Liebig-Universitaet Giessen
- Department Name
- Universitätsklinikum Gießen und Marburg GmbH
- Contact Person Name
- Thomas Wehler
- Contact Person Email
- thomas.wehler@innere.med.uni-giessen.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Medizinische Klinik und Poliklinik I
- Contact Person Name
- Martin Wermke
- Contact Person Email
- martin.wermke@uniklinikum-dresden.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Klinik I für Innere Medizin
- Contact Person Name
- Matthias Scheffler
- Contact Person Email
- matthias.scheffler@uk-koeln.de
- Site Name
- Universitaetsklinikum Augsburg
- Department Name
- II. Medizinische Klinik
- Contact Person Name
- Björn Hackanson
- Contact Person Email
- bjoern.hackanson@uk-augsburg.de
- Site Name
- Pius-Hospital Oldenburg
- Department Name
- Klinik für Hämatologie und Onkologie
- Contact Person Name
- Frank Griesinger
- Contact Person Email
- frank.griesinger@pius-hospital.de
Sweden
- Earliest CTIS Part Ii Submission Date
- 19-09-2024
- Latest Decision Or Authorization Date
- 12-08-2025
- Processing Time Days
- 327
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Studie behandlingsavdelning, B08:09
- Contact Person Name
- Simon Ekman
- Contact Person Email
- simon.ekman@ki.se
Portugal
- Earliest CTIS Part Ii Submission Date
- 19-09-2024
- Latest Decision Or Authorization Date
- 11-08-2025
- Processing Time Days
- 326
- Number Of Sites
- 2
- Number Of Participants
- 1
Sites
- Site Name
- Hospital CUF Porto S.A.
- Department Name
- Serviço Pneumologia
- Contact Person Name
- José Albino Lopes
- Contact Person Email
- jose.albino.lopes@cuf.pt
- Site Name
- Hospital Cuf Descobertas S.A.
- Department Name
- Serviço de Oncologia
- Contact Person Name
- Encarnação Teixeira
- Contact Person Email
- encarnacaoteixeira@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 19-09-2024
- Latest Decision Or Authorization Date
- 08-08-2025
- Processing Time Days
- 323
- Number Of Sites
- 3
- Number Of Participants
- 2
Sites
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Sc Ematologia Oncologia
- Contact Person Name
- Adriano Gravina
- Contact Person Email
- a.gravina@istitutotumori.na.it
- Site Name
- Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
- Department Name
- Oncologia Medica
- Contact Person Name
- Vanesa Gregorc
- Contact Person Email
- vanesa.gregorc@ircc.it
- Site Name
- Azienda Ospedaliero Universitaria Parma
- Department Name
- U. O. di Oncologia Medica
- Contact Person Name
- Marcello Tiseo
- Contact Person Email
- mtiseo@ao.pr.it
France
- Earliest CTIS Part Ii Submission Date
- 19-09-2024
- Latest Decision Or Authorization Date
- 18-09-2025
- Processing Time Days
- 364
- Number Of Sites
- 6
- Number Of Participants
- 31
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Service d’Onco-Pneumologie
- Contact Person Name
- David Planchard
- Contact Person Email
- david.planchard@gustaveroussy.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Unité d'Investigation Clinique
- Contact Person Name
- Hervé Lena
- Contact Person Email
- herve.lena@chu-rennes.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Unité de Phase I Oncologie labélisée CLIP
- Contact Person Name
- Laurent Greillier
- Contact Person Email
- Laurent.GREILLIER@ap-hm.fr
- Site Name
- Institut Curie
- Department Name
- Oncologie Médicale
- Contact Person Name
- Nicolas Girard
- Contact Person Email
- nicolas.girard2@curie.fr
- Site Name
- Centre Leon Berard
- Department Name
- Oncologie Médicale
- Contact Person Name
- Maurice Perol
- Contact Person Email
- maurice.perol@lyon.unicancer.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Plateforme de traitements oncologiques
- Contact Person Name
- Michaël Duruisseaux
- Contact Person Email
- michael.duruisseaux@chu-lyon.fr
Sponsor
Primary sponsor
- Full Name
- Boehringer Ingelheim International GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- zongertinib (BI 1810631)
- Active Substance
- zongertinib
- Modality
- Small molecule
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