Clinical trial • Phase III • Oncology

ZONGERTINIB for Non-small cell lung cancer

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

Overview

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

Key dates

Initial CTIS Submission Date
16-09-2025
First CTIS Authorization Date
19-01-2026

Trial design

Randomised, imfinzi (durvalumab) - concentrate for solution for infusion; keytruda (pembrolizumab) - concentrate for solution for infusion; tecentriq (atezolizumab) - concentrate for solution for infusion; opdivo (nivolumab) - concentrate for solution for infusion (doses/schedules not specified in the provided data)-controlled Phase III trial in Austria, Belgium, Denmark and others.

Randomised
Yes
Comparator
IMFINZI (durvalumab) - concentrate for solution for infusion; KEYTRUDA (pembrolizumab) - concentrate for solution for infusion; Tecentriq (atezolizumab) - concentrate for solution for infusion; OPDIVO (nivolumab) - concentrate for solution for infusion (doses/schedules not specified in the provided data)
Target Sample Size
307
Trial Duration For Participant
1095

Eligibility

Recruits 307 No vulnerable populations selected. Participants must be ≥18 years old (or over the legal age of consent in their country). Written informed consent is required in accordance with ICH-GCP and local legislation prior to inclusion..

Pregnancy Exclusion
3. Male or female patients. Women of childbearing potential (WOCBP)1 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. A list of contraception methods meeting these criteria is provided in the patient information and in the study protocol
Vulnerable Population
No vulnerable populations selected. Participants must be ≥18 years old (or over the legal age of consent in their country). Written informed consent is required in accordance with ICH-GCP and local legislation prior to inclusion.

Inclusion criteria

  • {"criterion_text":"- 1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial"}
  • {"criterion_text":"- 2. Patients must be ≥18 years old or over the legal age of consent in their country"}
  • {"criterion_text":"- 3. Male or female patients. Women of childbearing potential (WOCBP)1 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. A list of contraception methods meeting these criteria is provided in the patient information and in the study protocol"}
  • {"criterion_text":"- 4. HER2 mutation: Documented TKD activating HER2 mutations"}
  • {"criterion_text":"- 5. Histology and tumor sample: - Histologically confirmed diagnosis of primary NSCLC"}
  • {"criterion_text":"- 6. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status"}
  • {"criterion_text":"- 7. Staging: Pretherapeutic classification not exceeding Stage IIIB"}
  • {"criterion_text":"- 8. Performance status and organ function: - Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 - Adequate organ function based on laboratory values"}
  • {"criterion_text":"- Further inclusion criteria apply."}

Exclusion criteria

  • {"criterion_text":"- 1. Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56)"}
  • {"criterion_text":"- 2. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization"}
  • {"criterion_text":"- 3. Treatment with […] radiation therapy for primary NSCLC"}
  • {"criterion_text":"- 4. Co-occurring actionable mutation with approved targeted therapy (e.g. EGFR or ALK)"}
  • {"criterion_text":"- 5. Any investigational drug within 5 half-lives of the compound or any of its related material, if known"}
  • {"criterion_text":"- 6. History or presence of - Active or known pre-existing or history of non-infectious interstitial lung disease/pneumonitis - Active infectious disease requiring systemic therapy - Uncontrolled gastrointestinal disorders affecting drug intake/absorption - Previous or concomitant malignancies within the last 3 years, except certain effectively treated cancers - Significant and/or uncontrolled cardiovascular abnormalities, QTcF >470 msec, or ejection fraction <50%"}
  • {"criterion_text":"- Further exclusion criteria apply."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- DFS by investigator's assessment. DFS is defined as the time from randomization until recurrence of tumor or death from any cause, whichever occurs earlier","definition_or_measurement_approach":"DFS is defined as the time from randomization until recurrence of tumor or death from any cause, whichever occurs earlier"}

Secondary endpoints

  • {"endpoint_text":"- OS, defined as the time from randomization until death from any cause","definition_or_measurement_approach":"OS is defined as the time from randomization until death from any cause"}
  • {"endpoint_text":"- Occurrence of trial-related AEs ≥ Grade 3, graded according to CTCAE version 5.0, from first treatment administration (or from randomization for patients in the observation arm) until the earliest of tumor recurrence or 3 years since treatment start","definition_or_measurement_approach":"Adverse events graded per CTCAE v5.0 from first treatment administration (or from randomization for observation arm) until earliest of tumor recurrence or 3 years since treatment start"}

Recruitment

Planned Sample Size
307
Recruitment Window Months
127
Consent Approach
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. Participants are adults (≥18 years or legal age to consent). Subject information and informed consent forms are provided for participating countries (publication documents list ICFs in multiple country languages).

Geography

Total Number Of Sites
52
Total Number Of Participants
87

Austria

Earliest CTIS Part Ii Submission Date
09-12-2025
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
111
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
Department for Internal Medicine and Pneumology
Contact Person Name
Maximilian Hochmair
Site Name
Medizinische Universitaet Innsbruck
Department Name
Department of Internal Medicine V (Hematology and Oncology)
Contact Person Name
Florian Kocher

Belgium

Earliest CTIS Part Ii Submission Date
05-12-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
45
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Thoraxoncologie
Contact Person Name
Reinier Wener
Contact Person Email
reinier.wener@uza.be
Site Name
UZ Leuven
Department Name
Respiratoire Oncologie
Contact Person Name
Christophe DOOMS
Contact Person Email
christophe.dooms@uzleuven.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Oncology department
Contact Person Name
Anne Sibille
Contact Person Email
anne.sibille@chuliege.be

Denmark

Earliest CTIS Part Ii Submission Date
09-12-2025
Latest Decision Or Authorization Date
20-01-2026
Processing Time Days
42
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Region Sjaelland
Department Name
Klinisk Onkologisk Afdeling og Palliative Enheder
Contact Person Name
Malene Frank
Contact Person Email
malf@regionsjaelland.dk

Germany

Earliest CTIS Part Ii Submission Date
08-01-2026
Latest Decision Or Authorization Date
21-01-2026
Processing Time Days
13
Number Of Sites
8
Number Of Participants
21

Sites

Site Name
Asklepios Klinik Gauting GmbH
Department Name
Thorakale Onkologie
Contact Person Name
Niels Reinmuth
Contact Person Email
n.reinmuth@asklepios.com
Site Name
University Hospital Cologne AöR
Department Name
Klinik I für Innere Medizin, Lung Cancer Group Cologne (LCGC) am Zentrum für Integrierte Onkologie
Contact Person Name
Matthias Scheffler
Contact Person Email
matthias.scheffler@uk-koeln.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Thoraxonkologie
Contact Person Name
Petros Christopoulos
Site Name
Klinikum Esslingen GmbH
Department Name
Klinik für Kardiologie, Angiologie und Pneumologie
Contact Person Name
Martin Faehling
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Haus A9
Contact Person Name
Horst-Dieter Hummel
Contact Person Email
Hummel_h@ukw.de
Site Name
Pius-Hospital Oldenburg
Department Name
Klinik für Hämatologie und Onkologie, Universitätsklinik für Innere Medizin Onkologie
Contact Person Name
Frank Griesinger
Site Name
Klinikum Frankfurt Hoechst GmbH
Department Name
Klinik für Pneumologie, Beatmungsmedizin/Weaning, Thoraxonkologie und Schlafmedizin
Contact Person Name
Gerasimos Varelis
Contact Person Email
gerasimos.varelis@varisano.de
Site Name
LungenClinic Grosshansdorf GmbH
Department Name
Zentrum für Pneumologie und Thoraxchirurgie, Onkologischer Schwerpunkt
Contact Person Name
Martin Reck
Contact Person Email
m.reck@lungenclinic.de

Greece

Earliest CTIS Part Ii Submission Date
09-10-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
102
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Propaedeutic and Internal Medicine Clinic
Contact Person Name
Panagiota Oikonomopoulou
Contact Person Email
panagiota_oiko@hotmail.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
Oncology Unit, 3rd University Pathology Clinic
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
Contact Person Name
Giannis Mountzios
Contact Person Email
gmountzios@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
06-11-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
74
Number Of Sites
9
Number Of Participants
10

Sites

Site Name
Humanitas Mirasole S.p.A.
Department Name
Dip. Oncologia Medica ed Ematologia
Contact Person Name
Luca Toschi
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
S.S.D. Oncologia Polmonare
Contact Person Name
Silvia Novello
Contact Person Email
silvia.novello@unito.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Oncologia Medica Toraco Polmnare
Contact Person Name
Alessandro Morabito
Site Name
Humanitas Istituto Clinico Catanese S.p.A.
Department Name
UOC Oncologia Medica
Contact Person Name
Alessandro Russo
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
DAI di Chirurgia e Oncologia U.O.C. Oncologia Medica
Contact Person Name
Sara Pilotto
Contact Person Email
sara.pilotto@univr.it
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
SSD Oncologia Medica per la Patologia Toracica
Contact Person Name
Domenico Galetta
Contact Person Email
galetta@oncologico.bari.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia Medica Toraco-Polmonare
Contact Person Name
Laura Mazzeo
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Divisione Oncologia Medica 2
Contact Person Name
Federico Cappuzzo
Contact Person Email
federico.cappuzzo@ifo.it
Site Name
Humanitas Istituto Clinico Catanese S.p.A. (additional listed site)
Department Name
Oncologia Medica (listed)

Portugal

Earliest CTIS Part Ii Submission Date
30-10-2025
Latest Decision Or Authorization Date
21-01-2026
Processing Time Days
83
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Hospital Cuf Tejo S.A.
Department Name
Departamento de oncología
Contact Person Name
Telma Sequeira
Contact Person Email
sequeira.telma@gmail.com
Site Name
Hospital CUF Porto S.A.
Department Name
Serviço Pneumologia
Contact Person Name
VENCESLAU JOSE COELHO PINTO HESPANHOL
Contact Person Email
venceslau.hespanhol@cuf.pt
Site Name
Hospital Da Luz S.A.
Department Name
Departamento de oncología
Contact Person Name
João Godinho
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Servico de Medicina Oncologica
Contact Person Name
Isabel Azevedo

Romania

Earliest CTIS Part Ii Submission Date
14-01-2026
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
12
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Memorial Healthcare International S.R.L.
Department Name
Oncology
Contact Person Name
Ingrid Iordan
Contact Person Email
mireliordan@yahoo.com
Site Name
Polaris Medical S.A.
Department Name
Medical Oncology
Contact Person Name
Calin Cainap
Contact Person Email
calincainap2015@gmail.com
Site Name
Lotus Med S.R.L.
Department Name
Oncology
Contact Person Name
Iona Luca
Contact Person Email
ioana.luca@lotus-med.ro
Site Name
Ovidius Clinical Hospital S.R.L.
Department Name
Department of Oncology
Contact Person Name
Laura Mazilu
Contact Person Email
lauragrigorov@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
08-01-2026
Latest Decision Or Authorization Date
20-01-2026
Processing Time Days
12
Number Of Sites
1
Number Of Participants
2

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

Spain

Earliest CTIS Part Ii Submission Date
09-10-2025
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
169
Number Of Sites
15
Number Of Participants
29

Sites

Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Servicio de Oncología Médica
Contact Person Name
Mariano Provencio Pulla
Contact Person Email
mprovenciop@gmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Unidad de Ensayos Clínicos Fase I
Contact Person Name
Manuel Domine Gomez
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Servicio de Oncología
Contact Person Name
Jose Carlos Benitez Montañez
Contact Person Email
josecarlos.benitez@ibima.eu
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Servicio de Oncología Médica
Contact Person Name
Pilar Garrido
Contact Person Email
pilargarridol@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Servicio de Oncología
Contact Person Name
Reyes Bernabe Caro
Contact Person Email
bernabeensayos@gmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Servicio de Oncología Médica y Hematología
Contact Person Name
Amelia Insa
Contact Person Email
ameliainsamolla@gmail.com
Site Name
Hospital Universitario De Navarra
Department Name
servicio oncologia
Contact Person Name
Hugo Arasanz Esteban
Site Name
Hospital Universitario De Burgos
Department Name
Servicio de Oncología
Contact Person Name
Cristina Bayona Antón
Contact Person Email
cpablod@saludcastillayleon.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Servicio Oncología Médica
Contact Person Name
Jon Zugazagoitia
Contact Person Email
j.zugazagoitia.imas12@h12o.es
Site Name
Hospital Del Mar
Department Name
Servicio de Oncología Médica
Contact Person Name
Edurne Arriola Aperribay
Contact Person Email
earriola@psmar.cat
Site Name
Hospital General Universitario De Elche
Department Name
Camino De La Almazara 11
Contact Person Name
Javier Benítez
Site Name
Salut Sant Joan De Reus
Department Name
Servicio Ongología
Contact Person Name
Sergio Peralta
Site Name
Hospital De Jerez De La Frontera
Department Name
Servicio de oncología
Contact Person Name
Jesús Corral Jaime
Site Name
Institut Catala D'oncologia
Department Name
Unidad de Investigación Clínica
Contact Person Name
Ernest Nadal Alforja
Contact Person Email
esnadal@iconcologia.net
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de Oncología Médica
Contact Person Name
Alexandre Martínez Martí
Contact Person Email
amartinezmarti@vhio.net

Sweden

Earliest CTIS Part Ii Submission Date
09-12-2025
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
126
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Oncology department
Contact Person Name
Andreas Hallqvist
Contact Person Email
andreas.hallqvist@vgregion.se
Site Name
Karolinska University Hospital
Department Name
Tema Cancer, J6:20
Contact Person Name
Simon Ekman
Contact Person Email
simon.ekman@ki.se

Sponsor

Primary sponsor

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

Contract research organisations

Name
IQVIA Limited
Responsibilities
sponsor duties codes: 1,12; contact: josephine.kench@iqvia.com
Name
IQVIA RDS Hellas Single Member S.A.
Responsibilities
sponsor duties codes: 1,12; contact: EUCTR_Greece@iqvia.com

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsor duties codes: 1, 12 (as listed)","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"sponsor duties codes: 1, 12 (as listed)","organisation_type":"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 USE
Route
ORAL USE
Authorisation Status
Not authorised
Investigational Product Name
OPDIVO 10 mg/mL concentrate for solution for infusion.
Active Substance
NIVOLUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
480 mg (max daily dose amount listed)
Investigational Product Name
IMFINZI 50 mg/mL concentrate for solution for infusion.
Active Substance
DURVALUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
1500 mg (max daily dose amount listed)
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
Maximum Dose
200 mg (max daily dose amount listed)
Investigational Product Name
Tecentriq 1 200 mg concentrate for solution for infusion
Active Substance
ATEZOLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
1200 mg (max daily dose amount listed)

Related trials

Other published trials that may interest you.