Clinical trial • Phase III • Oncology

ZONGERTINIB for Non-small cell lung cancer | Non-squamous non-small cell lung cancer

Phase III trial of ZONGERTINIB for Non-small cell lung cancer | Non-squamous non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer | Non-squamous non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Small molecule | Monoclonal antibody

Key dates

Initial CTIS Submission Date
31-10-2023
First CTIS Authorization Date
05-03-2024

Trial design

Randomised, open-label, standard of care: pembrolizumab (keytruda) plus a platinum-pemetrexed doublet chemotherapy (cisplatin or carboplatin plus pemetrexed) as per smpc/product information (comparator arm).-controlled Phase III trial in Hungary, Greece, Belgium and others.

Randomised
Yes
Open Label
Yes
Comparator
Standard of care: pembrolizumab (KEYTRUDA) plus a platinum-pemetrexed doublet chemotherapy (cisplatin or carboplatin plus pemetrexed) as per SmPC/Product Information (comparator arm).
Biomarker Stratified
True, HER2 tyrosine kinase domain (TKD) mutation
Target Sample Size
303

Eligibility

Recruits 303 No vulnerable populations selected. Participants must be ≥18 years (or above the legal age of consent locally). A signed and dated written informed consent form (ICF) in accordance with ICH-GCP and local legislation is required prior to admission to the trial; assent for minors is not applicable because minors are excluded..

Pregnancy Exclusion
"Male or female patients. Women of childbearing potential (WOCBP)1 and men who are able to father a child must be ready and able to use dual highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly."
Vulnerable Population
No vulnerable populations selected. Participants must be ≥18 years (or above the legal age of consent locally). A signed and dated written informed consent form (ICF) in accordance with ICH-GCP and local legislation is required prior to admission to the trial; assent for minors is not applicable because minors are excluded.

Inclusion criteria

  • {"criterion_text":"-Signed and dated written informed consent form (ICF) in accordance with ICH-GCP and local legislation prior to admission to the trial."}
  • {"criterion_text":"-Adequate organ function as defined in the protocol."}
  • {"criterion_text":"-Life expectancy of at least 12 weeks at the start of treatment in the opinion of the investigator."}
  • {"criterion_text":"-\"Male or female patients. Women of childbearing potential (WOCBP)1 and men who are able to father a child must be ready and able to use dual highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.\""}
  • {"criterion_text":"-Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the ICF."}
  • {"criterion_text":"-Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous NSCLC."}
  • {"criterion_text":"-Documented HER2 mutation in the TKD as per local lab results."}
  • {"criterion_text":"-An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status. If no archival tissue is available, this may be acceptable in exceptional cases after written agreement with the sponsor."}
  • {"criterion_text":"-Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease and are not eligible for curative therapy."}
  • {"criterion_text":"-Presence of at least one measurable non-CNS lesion according to RECIST 1.1, as determined by the local site investigator/radiology assessment."}
  • {"criterion_text":"-\"Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the SmPC/Product Information.\""}
  • {"criterion_text":"-Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 [R01-0787]."}

Exclusion criteria

  • {"criterion_text":"-\"Previous or concomitant malignancies other than the one treated in this trial within the last 5 years, except; i. effectively treated non-melanoma skin cancers ii. effectively treated carcinoma in situ of the cervix iii. effectively treated ductal carcinoma in situ iv. other effectively treated malignancy that is considered cured by local treatment\""}
  • {"criterion_text":"-\"Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval.\""}
  • {"criterion_text":"-\"Further exclusion criteria apply.\""}
  • {"criterion_text":"-Tumors with targetable alterations with approved available therapy."}
  • {"criterion_text":"-Lung-specific intercurrent clinically significant severe illness based on investigators assessment."}
  • {"criterion_text":"-Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial."}
  • {"criterion_text":"-Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening, e.g. hip replacement."}
  • {"criterion_text":"-\"Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient’s ability to comply with the trial or interfere with the evaluation of the safety and efficacy of the test drug.\""}
  • {"criterion_text":"-\"History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of ≥ III or IV, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the investigator. Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to randomization.\""}
  • {"criterion_text":"-Any clinically important abnormalities (as assessed by the investigator) in rhythm, conduction, or morphology of resting electrocardiograms, e.g. complete left bundle branch block, third degree heart block."}
  • {"criterion_text":"-Mean resting corrected QT interval (QTcF) >470 msec."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-The primary endpoint is PFS according to RECIST 1.1 determined by blinded central independent review.","definition_or_measurement_approach":"Progression-free survival (PFS) per RECIST 1.1 determined by blinded central independent review."}

Secondary endpoints

  • {"endpoint_text":"-The key secondary endpoints are OR according to RECIST 1.1, determined by blinded central independent review, the change from baseline to Week 25 of NSCLC-SAQ total score, and OS.","definition_or_measurement_approach":"Objective response (OR) per RECIST 1.1 determined by blinded central independent review; change from baseline to Week 25 in NSCLC-SAQ total score; overall survival (OS)."}
  • {"endpoint_text":"-Duration of response (DoR), determined by blinded central independent review.","definition_or_measurement_approach":"Duration of response (DoR) assessed by blinded central independent review (RECIST 1.1 based assessments)."}
  • {"endpoint_text":"-Progression free survival, determined by blinded central independent review.","definition_or_measurement_approach":"PFS determined by blinded central independent review (RECIST 1.1)."}
  • {"endpoint_text":"-Bi-compartmental PFS, determined by blinded central independent review.","definition_or_measurement_approach":"Bi-compartmental PFS determined by blinded central independent review (method per protocol)."}
  • {"endpoint_text":"-Overall response, determined by blinded central independent review.","definition_or_measurement_approach":"Overall response per RECIST 1.1 determined by blinded central independent review."}
  • {"endpoint_text":"-Further patient reported outcomes (PROs) from NSCLC-SAQ and EORTC QLQ-C30 domain scores, analyzed as change from baseline to Week 25","definition_or_measurement_approach":"Patient-reported outcomes (NSCLC-SAQ and EORTC QLQ-C30 domain scores) analyzed as change from baseline to Week 25."}
  • {"endpoint_text":"-Occurrence of AEs during the on-treatment period, graded according to CTCAE version 5.0.","definition_or_measurement_approach":"Adverse events (AEs) during on-treatment period graded per CTCAE v5.0."}
  • {"endpoint_text":"-Occurrence of serious AEs (SAEs) during the on-treatment period, graded according to CTCAE version 5.0.","definition_or_measurement_approach":"Serious adverse events (SAEs) during on-treatment period graded per CTCAE v5.0."}

Recruitment

Digital Remote Recruitment
True, recruitment materials explicitly include digital channels such as social media posts, online banner ads, recruitment website translations, and an animation/video storyboard for public-facing recruitment.
Planned Sample Size
303
Recruitment Window Months
45
Consent Approach
Written informed consent: a signed and dated written informed consent form (ICF) in accordance with ICH-GCP and local legislation is required prior to admission to the trial. Participants must be ≥18 years (or local legal age). Subject information and ICF documents are provided in multiple languages (examples in the document list: English, Dutch, French, German, Spanish, Portuguese, Polish, Italian, Swedish, Norwegian, Greek, Hungarian). Specific ICF variants include biobanking, pregnant-partner, paired-biopsies, re-consent documents as applicable.

Methods

  • Social media posts (country-specific social media recruitment materials provided; e.g., files named social-media-posts for BE, ES, PL, DE, NL, SE, PT, AT, NO).
  • Online banner advertisements (files named online-banner-ads for multiple countries).
  • Patient letters (country-specific patient-letter documents).
  • Patient flyers and brochures (patient-flyer, patient-brochure files for multiple countries).
  • Animation/video/storyboard (K2 recruitment material animation/video/story-board available for multiple countries).
  • Participant study guide / study-guideline / study-guide (participant-study-guide files per country).
  • Recruitment arrangements documents and recruitment website translations (documents labelled recruitment arrangements and recruitment-website translations per country).
  • GP / healthcare professional letters and trial ID cards (documents labelled gp-letter, trial-id-card in country packs).

Geography

Total Number Of Sites
63
Total Number Of Participants
121

Hungary

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
06-03-2024
Processing Time Days
51
Number Of Sites
5
Number Of Participants
5

Sites

Site Name
Deszki Mellkasi Betegsegek Szakkorhaza
Department Name
1st Pulmonology Department
Principal Investigator Name
Klara Szalontai
Principal Investigator Email
szalontai@deszkikorhaz.hu
Contact Person Name
Klara Szalontai
Contact Person Email
szalontai@deszkikorhaz.hu
Site Name
Orszagos Onkologiai Intezet
Department Name
Chest & abdominal tumors & clin. pharmacology dept.
Principal Investigator Name
Tunde Nagy
Principal Investigator Email
drnt@freemail.hu
Contact Person Name
Tunde Nagy
Contact Person Email
drnt@freemail.hu
Site Name
Koranyi National Institute For Pulmonology
Department Name
1st Pulmonology Department
Principal Investigator Name
Judit Moldvay
Principal Investigator Email
drmoldvay@hotmail.com
Contact Person Name
Judit Moldvay
Contact Person Email
drmoldvay@hotmail.com
Site Name
Farkasgyepui Tudogyogyintezet
Department Name
1st Pulmonology
Principal Investigator Name
Zsolt Kiraly
Principal Investigator Email
dr.kiraly.zsolt@gmail.com
Contact Person Name
Zsolt Kiraly
Contact Person Email
dr.kiraly.zsolt@gmail.com
Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
I. Pulmonology Department
Principal Investigator Name
Zsolt Papai Szekely
Principal Investigator Email
zsoltpapai@yahoo.com
Contact Person Name
Zsolt Papai Szekely
Contact Person Email
zsoltpapai@yahoo.com

Greece

Earliest CTIS Part Ii Submission Date
17-11-2023
Latest Decision Or Authorization Date
05-06-2024
Processing Time Days
201
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd Department of Internal Medicine
Principal Investigator Name
Konstantinos Syrigos
Principal Investigator Email
ksyrigos.trials@gmail.com
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com
Site Name
Henry Dunant Hospital Center
Department Name
4th Oncology Department and Clinical Trials Unit
Principal Investigator Name
Giannis Mountzios
Principal Investigator Email
gmountzios@gmail.com
Contact Person Name
Giannis Mountzios
Contact Person Email
gmountzios@gmail.com
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Pulmonary Clinic Aristotle University of Thessaloniki
Principal Investigator Name
Dionysis Spyratos
Principal Investigator Email
diospyrato@yahoo.gr
Contact Person Name
Dionysis Spyratos
Contact Person Email
diospyrato@yahoo.gr

Belgium

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
08-03-2024
Processing Time Days
32
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Institut Jules Bordet
Department Name
Oncology
Principal Investigator Name
Mariana Brandao
Principal Investigator Email
Mariana.brandao@bordet.be
Contact Person Name
Mariana Brandao
Contact Person Email
Mariana.brandao@bordet.be
Site Name
UZ Leuven
Department Name
Respiratory Oncology
Principal Investigator Name
Christophe Dooms
Principal Investigator Email
christophe.dooms@uzleuven.be
Contact Person Name
Christophe Dooms
Contact Person Email
christophe.dooms@uzleuven.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Respiratory Oncology
Principal Investigator Name
Dieter Stevens
Principal Investigator Email
dieter.stevens@uzgent.be
Contact Person Name
Dieter Stevens
Contact Person Email
dieter.stevens@uzgent.be

Spain

Earliest CTIS Part Ii Submission Date
16-01-2024
Latest Decision Or Authorization Date
31-05-2024
Processing Time Days
136
Number Of Sites
13
Number Of Participants
22

Sites

Site Name
Hospital Universitario La Paz
Department Name
Servicio de Oncología
Principal Investigator Name
Javier De Castro Carpeño
Principal Investigator Email
javier.decastro@salud.madrid.org
Contact Person Name
Javier De Castro Carpeño
Site Name
Hospital Universitario Basurto
Department Name
Hospital de Basurto
Principal Investigator Name
Maria Ángeles Sala González
Principal Investigator Email
marian.salagonzalez@osakidetza.eus
Contact Person Name
Maria Ángeles Sala González
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Servicio de Oncología
Principal Investigator Name
Reyes Bernabe Caro
Principal Investigator Email
reyesbernab@yahoo.es
Contact Person Name
Reyes Bernabe Caro
Contact Person Email
reyesbernab@yahoo.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Servicio de Oncología
Principal Investigator Name
Manuel Ángel Cobo Dols
Principal Investigator Email
manuelcobodols@yahoo.es
Contact Person Name
Manuel Ángel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Servicio de Oncología
Principal Investigator Name
Amelia Insa
Principal Investigator Email
ameliainsamolla@gmail.com
Contact Person Name
Amelia Insa
Contact Person Email
ameliainsamolla@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Servicio de Oncología
Principal Investigator Name
Andrés Barba
Principal Investigator Email
abarba@santpau.cat
Contact Person Name
Andrés Barba
Contact Person Email
abarba@santpau.cat
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Servicio de Oncología
Principal Investigator Name
Bartomeu Massuti Sureda
Principal Investigator Email
bmassutis@seom.org
Contact Person Name
Bartomeu Massuti Sureda
Contact Person Email
bmassutis@seom.org
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Complexo Hospitalario Universitario A Coruna
Principal Investigator Name
Rosario García Campelo
Principal Investigator Email
MA.Rosario.Garcia.Campelo@sergas.es
Contact Person Name
Rosario García Campelo
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Servicio de Oncología
Principal Investigator Name
Antonio Calles Blanco
Principal Investigator Email
antonio.calles@live.com
Contact Person Name
Antonio Calles Blanco
Contact Person Email
antonio.calles@live.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Servicio de Oncología
Principal Investigator Name
Pilar Garrido
Principal Investigator Email
pilargarridol@gmail.com
Contact Person Name
Pilar Garrido
Contact Person Email
pilargarridol@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Servicio de Oncología
Principal Investigator Name
Jon Zugazagoitia
Principal Investigator Email
j.zugazagoitia.imas12@h12o.es
Contact Person Name
Jon Zugazagoitia
Contact Person Email
j.zugazagoitia.imas12@h12o.es
Site Name
Institut Catala D'oncologia
Department Name
Servicio de Oncología
Principal Investigator Name
Ernest Nadal Alforja
Principal Investigator Email
esnadal@iconcologia.net
Contact Person Name
Ernest Nadal Alforja
Contact Person Email
esnadal@iconcologia.net
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de Oncología
Principal Investigator Name
Enriqueta Felip
Principal Investigator Email
efelip@vhio.net
Contact Person Name
Enriqueta Felip
Contact Person Email
efelip@vhio.net

Germany

Earliest CTIS Part Ii Submission Date
30-01-2024
Latest Decision Or Authorization Date
03-06-2024
Processing Time Days
125
Number Of Sites
8
Number Of Participants
21

Sites

Site Name
University Hospital Cologne AöR
Department Name
Klinik I für Innere Medizin
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 Tuebingen AöR
Department Name
Medizinische Klinik Innere Medizin VIII
Principal Investigator Name
Thorben Groß
Principal Investigator Email
thorben.gross@med.uni-tuebingen.de
Contact Person Name
Thorben Groß
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Internistische Onkologie der Thoraxtumoren
Principal Investigator Name
Petros Christopoulos
Principal Investigator Email
petros.christopoulos@med.uni-heidelberg.de
Contact Person Name
Petros Christopoulos
Site Name
Universitaetsklinikum Augsburg
Department Name
II. Medizinische Klinik, Hämatologie, Onkologie
Principal Investigator Name
Björn Hackanson
Principal Investigator Email
bjoern.hackanson@uk-augsburg.de
Contact Person Name
Björn Hackanson
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Medizinische Klink IV/V Onkologie
Principal Investigator Name
Thomas Wehler
Principal Investigator Email
thomas.wehler@innere.med.uni-giessen.de
Contact Person Name
Thomas Wehler
Site Name
Pius-Hospital Oldenburg
Department Name
Klinik für Hämatologie und Onkologie
Principal Investigator Name
Frank Griesinger
Principal Investigator Email
frank.griesinger@pius-hospital.de
Contact Person Name
Frank Griesinger
Site Name
Gemeinschaftskrankenhaus Havelhoehe gGmbH
Department Name
Klinik für Anthroposophische Medizin
Principal Investigator Name
Christian Grah
Principal Investigator Email
cgrah@havelhoehe.de
Contact Person Name
Christian Grah
Contact Person Email
cgrah@havelhoehe.de
Site Name
Technische Universitat Dresden
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Felix Saalfeld
Principal Investigator Email
felix.saalfeld@uniklinikum-dresden.de
Contact Person Name
Felix Saalfeld

Poland

Earliest CTIS Part Ii Submission Date
28-02-2024
Latest Decision Or Authorization Date
05-06-2024
Processing Time Days
98
Number Of Sites
4
Number Of Participants
2

Sites

Site Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Department Name
Oncology Department
Principal Investigator Name
Katarzyna Stencel
Principal Investigator Email
kstencel@wcpit.org
Contact Person Name
Katarzyna Stencel
Contact Person Email
kstencel@wcpit.org
Site Name
Instytut Centrum Zdrowia Matki Polki
Department Name
Department of Oncology
Principal Investigator Name
Ewa Kalinka
Principal Investigator Email
ewakalinka@wp.pl
Contact Person Name
Ewa Kalinka
Contact Person Email
ewakalinka@wp.pl
Site Name
Med Polonia Sp. z o.o.
Department Name
Hospital and Outpatient Clinic
Principal Investigator Name
Rodryg Ramlau
Principal Investigator Email
rodrygramlau@gmail.com
Contact Person Name
Rodryg Ramlau
Contact Person Email
rodrygramlau@gmail.com
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Department of Lung and Chest Tumors
Principal Investigator Name
Dariusz Kowalski
Principal Investigator Email
Dariusz.Kowalski@pib-nio.pl
Contact Person Name
Dariusz Kowalski
Contact Person Email
Dariusz.Kowalski@pib-nio.pl

Austria

Earliest CTIS Part Ii Submission Date
29-02-2024
Latest Decision Or Authorization Date
31-05-2024
Processing Time Days
116
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Universitaetsklinikum Krems
Department Name
Department for Pneumology
Principal Investigator Name
Klaus Hackner
Principal Investigator Email
klaus.hackner@krems.lknoe.at
Contact Person Name
Klaus Hackner
Contact Person Email
klaus.hackner@krems.lknoe.at
Site Name
Krankenhaus Nord Klinik Floridsdorf
Department Name
Clinic for Inner Med.and Pneumology
Principal Investigator Name
Maximilian Hochmair
Principal Investigator Email
maximilian.hochmair@gesundheitsverbund.at
Contact Person Name
Maximilian Hochmair

Sweden

Earliest CTIS Part Ii Submission Date
23-02-2024
Latest Decision Or Authorization Date
11-03-2024
Processing Time Days
17
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Department Name
Lungonkologisk mottagning
Principal Investigator Name
Andreas Hallqvist
Principal Investigator Email
andreas.hallqvist@vgregion.se
Contact Person Name
Andreas Hallqvist
Contact Person Email
andreas.hallqvist@vgregion.se
Site Name
Karolinska University Hospital
Department Name
Studie behandlingsavdelning, B08:09
Principal Investigator Name
Simon Ekman
Principal Investigator Email
simon.ekman@ki.se
Contact Person Name
Simon Ekman
Contact Person Email
simon.ekman@ki.se

Portugal

Earliest CTIS Part Ii Submission Date
21-02-2024
Latest Decision Or Authorization Date
03-06-2024
Processing Time Days
103
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Hospital Cuf Tejo S.A.
Department Name
Serviço de Oncologia
Principal Investigator Name
Telma Sequeira
Principal Investigator Email
sequeira.telma@gmail.com
Contact Person Name
Telma Sequeira
Contact Person Email
sequeira.telma@gmail.com
Site Name
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
Department Name
Not applicable
Principal Investigator Name
Paula Alves
Principal Investigator Email
alvespaula57@gmail.com
Contact Person Name
Paula Alves
Contact Person Email
alvespaula57@gmail.com
Site Name
Hospital CUF Porto S.A.
Department Name
Serviço Pneumologia
Principal Investigator Name
Venceslau Hespanhol
Principal Investigator Email
venceslau.hespanhol@cuf.pt
Contact Person Name
Venceslau Hespanhol
Contact Person Email
venceslau.hespanhol@cuf.pt

Netherlands

Earliest CTIS Part Ii Submission Date
27-02-2024
Latest Decision Or Authorization Date
07-03-2024
Processing Time Days
9
Number Of Sites
2
Number Of Participants
14

Sites

Site Name
University Hospital Maastricht
Department Name
Pulmonary diseases
Principal Investigator Name
Lizza Hendriks
Principal Investigator Email
lizza.hendriks@mumc.nl
Contact Person Name
Lizza Hendriks
Contact Person Email
lizza.hendriks@mumc.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Thoracic Oncology
Principal Investigator Name
Joop de Langen
Principal Investigator Email
j.d.langen@nki.nl
Contact Person Name
Joop de Langen
Contact Person Email
j.d.langen@nki.nl

France

Earliest CTIS Part Ii Submission Date
10-12-2023
Latest Decision Or Authorization Date
31-05-2024
Processing Time Days
173
Number Of Sites
9
Number Of Participants
27

Sites

Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service de Pneumologie
Principal Investigator Name
Céline Mascaux
Principal Investigator Email
celine.mascaux@chru-strasbourg.fr
Contact Person Name
Céline Mascaux
Site Name
Institut Gustave Roussy
Department Name
Bâtiment Principal
Principal Investigator Name
David Planchard
Principal Investigator Email
david.planchard@gustaveroussy.fr
Contact Person Name
David Planchard
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Pôle des voies respiratoires
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
Assistance Publique Hopitaux De Marseille
Department Name
Service d'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
Hopital Tenon
Department Name
Service Pneumologie
Principal Investigator Name
Jacques Cadranel
Principal Investigator Email
jacques.cadranel@aphp.fr
Contact Person Name
Jacques Cadranel
Contact Person Email
jacques.cadranel@aphp.fr
Site Name
Centre Leon Berard
Department Name
Département Oncologie Médicale
Principal Investigator Name
Maurice Perol
Principal Investigator Email
maurice.perol@lyon.unicancer.fr
Contact Person Name
Maurice Perol
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Recherche Clinique de Pneumologie
Principal Investigator Name
Hervé Lena
Principal Investigator Email
herve.lena@chu-rennes.fr
Contact Person Name
Hervé Lena
Contact Person Email
herve.lena@chu-rennes.fr
Site Name
Institut Curie
Department Name
Service d'Oncologie médicale
Principal Investigator Name
Nicolas Girard
Principal Investigator Email
nicolas.girard2@curie.fr
Contact Person Name
Nicolas Girard
Contact Person Email
nicolas.girard2@curie.fr
Site Name
Hospices Civils De Lyon
Department Name
Service de Pneumologie
Principal Investigator Name
Michaël Duruisseaux
Principal Investigator Email
michael.duruisseaux@chu-lyon.fr
Contact Person Name
Michaël Duruisseaux

Italy

Earliest CTIS Part Ii Submission Date
23-01-2024
Latest Decision Or Authorization Date
11-03-2024
Processing Time Days
48
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Department Name
AO Ospedale di Circolo e Fondazione Macchi
Principal Investigator Name
Elena Bolzacchini
Principal Investigator Email
elena.bolzacchini@asst-settelaghi.it
Contact Person Name
Elena Bolzacchini
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
U.O. di Oncologia Medica
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
Istituto Tumori Bari Giovanni Paolo II
Department Name
SSD Oncologia Medica Patologia Toracica
Principal Investigator Name
Domenico Galetta
Principal Investigator Email
galetta@oncologico.bari.it
Contact Person Name
Domenico Galetta
Contact Person Email
galetta@oncologico.bari.it
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Department Name
Oncologia Medica
Principal Investigator Name
Vanesa Gregorc
Principal Investigator Email
vanesa.gregorc@ircc.it
Contact Person Name
Vanesa Gregorc
Contact Person Email
vanesa.gregorc@ircc.it
Site Name
Universita' Degli Studi Di Roma La Sapienza
Department Name
UOC Oncologia Medica A
Principal Investigator Name
Monica Verrico
Principal Investigator Email
monica.verrico@uniroma1.it
Contact Person Name
Monica Verrico
Contact Person Email
monica.verrico@uniroma1.it
Site Name
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name
U.O. di Oncologia Medica
Principal Investigator Name
Hector Jose Soto Parra
Principal Investigator Email
hsotoparra@yahoo.it
Contact Person Name
Hector Jose Soto Parra
Contact Person Email
hsotoparra@yahoo.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Oncologia medica
Principal Investigator Name
Alessandro Morabito
Principal Investigator Email
a.morabito1@istitutotumori.na.it
Contact Person Name
Alessandro Morabito

Norway

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
08-03-2024
Processing Time Days
32
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Oslo Universitetssykehus HF
Department Name
Avdeling for kreftbehandling
Principal Investigator Name
Maria Moksnes Bjaanæs
Principal Investigator Email
mamok@ous-hf.no
Contact Person Name
Maria Moksnes Bjaanæs
Contact Person Email
mamok@ous-hf.no
Site Name
Vestre Viken HF
Department Name
Onkologisk poliklinikk
Principal Investigator Name
Odd Terje Brustugun
Principal Investigator Email
ot.brustugun@gmail.com
Contact Person Name
Odd Terje Brustugun
Contact Person Email
ot.brustugun@gmail.com

Sponsor

Primary sponsor

Full Name
Boehringer Ingelheim International GmbH
Organisation Type
Industry
Country Of Registered Address
Germany

Contract research organisations

Name
IQVIA RDS Hellas Single Member S.A.
Responsibilities
Sponsor duties (code 2); contact euctr_greece@iqvia.com; phone +302106873300

Third parties

  • {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"sponsorDuties code 2","organisation_type":"Non-Pharmaceutical company"}

Co-sponsors

  • Boehringer Ingelheim Espana S.A.

Investigational products

Investigational Product Name
BI 1810631
Active Substance
ZONGERTINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Not authorised / investigational (prodAuthStatus=1)
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised / marketing authorisation present (prodAuthStatus=2, EU MA details provided)
Maximum Dose
200 mg (maxDailyDoseAmount=200)
Investigational Product Name
ALIMTA 500 mg powder for concentrate for solution for infusion
Active Substance
PEMETREXED
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised / marketing authorisation present (prodAuthStatus=2)
Maximum Dose
500 mg/m2 (maxDailyDoseAmount=500 mg/m2)
Investigational Product Name
Cisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised / marketing authorisation present (prodAuthStatus=2)
Maximum Dose
75 mg/m2 (maxDailyDoseAmount=75 mg/m2)
Investigational Product Name
Carboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised / marketing authorisation present (prodAuthStatus=2)
Maximum Dose
750 mg (maxDailyDoseAmount=750 mg)

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