Clinical trial • Phase II • Oncology
LAZERTINIB for Non-small cell lung cancer (EGFR-mutated) | Locally advanced or metastatic non-small cell lung cancer
Phase II trial of LAZERTINIB for Non-small cell lung cancer (EGFR-mutated) | Locally advanced or metastatic non-small cell lung cancer. open-label.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer (EGFR-mutated) | Locally advanced or metastatic non-small cell lung cancer
- Trial Stage
- Phase II
- Drug Modality
- Other antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 08-08-2025
- First CTIS Authorization Date
- 27-11-2025
Trial design
open-label Phase II trial in Belgium, Finland, France and others.
- Open Label
- Yes
- Biomarker Stratified
- True - biomarker: EGFR mutation (Ex19del or Ex21 L858R)
- Target Sample Size
- 354
Eligibility
Recruits 354 No vulnerable population selected; trial enrols adults only; informed consent to be obtained from participants. No assent procedures for minors are described in the CTIS record..
- Vulnerable Population
- No vulnerable population selected; trial enrols adults only; informed consent to be obtained from participants. No assent procedures for minors are described in the CTIS record.
Inclusion criteria
- {"criterion_text":"- 1.Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy\n- 2. Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the US), or an accredited local laboratory (sites outside of the US) in accordance with site standard of care\n- 3. Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated\n- 4. Any toxicities from prior systemic anticancer therapy must have resolved to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or baseline level (except for alopecia [any grade], grade <=2 peripheral neuropathy, or grade <=2 hypothyroidism stable on hormone replacement)\n- 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1"}
Exclusion criteria
- {"criterion_text":"- 1. Medical history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis\n- 2. Had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study\n- 3. Participant has uncontrolled tumour-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing)\n- 4. Received an investigational treatment that has not been cleared (based on at least 5 half lives of any pharmaceutical treatment) before the planned first dose of study treatment or is currently enrolled in an investigational study\n- 5. Has a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- PFS according to RECIST v1.1 by investigator assessment","definition_or_measurement_approach":"Progression-free survival measured according to RECIST v1.1 as assessed by the investigator"}
Recruitment
- Planned Sample Size
- 354
- Recruitment Window Months
- 60
- Consent Approach
- Informed consent to be obtained from participants. Country-specific subject information sheets and informed consent forms are provided (documents available in multiple languages including French, German, Greek, Italian, Portuguese, Spanish, Polish, Dutch, Finnish and English). ICFs include withdrawal and pregnancy appendices where applicable. No assent process for minors is described in the CTIS record.
Geography
- Total Number Of Sites
- 43
- Total Number Of Participants
- 118
Belgium
- Earliest CTIS Part Ii Submission Date
- 31-10-2025
- Latest Decision Or Authorization Date
- 23-12-2025
- Processing Time Days
- 53
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- CHU UCL Namur - Site Godinne
- Principal Investigator Name
- Sebahat Ocak
- Principal Investigator Email
- sebahat.ocak@chuuclnamur.uclouvain.be
- Contact Person Name
- Sebahat Ocak
- Contact Person Email
- sebahat.ocak@chuuclnamur.uclouvain.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Pulmonology
- 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
- Ziekenhuis Oost Limburg
- Department Name
- Pulmonology
- Principal Investigator Name
- Maarten Criel
- Principal Investigator Email
- maarten.criel@zol.be
- Contact Person Name
- Maarten Criel
- Contact Person Email
- maarten.criel@zol.be
- Site Name
- UZ Leuven
- Department Name
- Pulmonology
- Principal Investigator Name
- Christophe Dooms
- Principal Investigator Email
- christophe.dooms@uzleuven.be
- Contact Person Name
- Christophe Dooms
- Contact Person Email
- christophe.dooms@uzleuven.be
Finland
- Earliest CTIS Part Ii Submission Date
- 31-10-2025
- Latest Decision Or Authorization Date
- 28-11-2025
- Processing Time Days
- 28
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Oulu University Hospital
- Department Name
- Department of Oncology and Radiotherapy
- Principal Investigator Name
- Jussi Koivunen
- Principal Investigator Email
- jussi.koivunen@pohde.fi
- Contact Person Name
- Jussi Koivunen
- Contact Person Email
- jussi.koivunen@pohde.fi
- Site Name
- Turku University Hospital
- Department Name
- Department of Pulmonary Medicine
- Principal Investigator Name
- Maria Silvoniemi
- Principal Investigator Email
- maria.silvoniemi@varha.fi
- Contact Person Name
- Maria Silvoniemi
- Contact Person Email
- maria.silvoniemi@varha.fi
- Site Name
- HUS-yhtymae
- Department Name
- Comprehensive Cancer Center
- Principal Investigator Name
- Ilkka Liikanen
- Principal Investigator Email
- ilkka.liikanen@hus.fi
- Contact Person Name
- Ilkka Liikanen
- Contact Person Email
- ilkka.liikanen@hus.fi
France
- Earliest CTIS Part Ii Submission Date
- 14-11-2025
- Latest Decision Or Authorization Date
- 02-12-2025
- Processing Time Days
- 18
- Number Of Sites
- 4
- Number Of Participants
- 17
Sites
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Oncology
- Principal Investigator Name
- Renaud DESCOURT
- Principal Investigator Email
- renaud.descourt@chu-brest.fr
- Contact Person Name
- Renaud DESCOURT
- Contact Person Email
- renaud.descourt@chu-brest.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Thoracic oncoly unit
- Principal Investigator Name
- Denis MORO-SIBILOT
- Principal Investigator Email
- dmoro-sibilot@chu-grenoble.fr
- Contact Person Name
- Denis MORO-SIBILOT
- Contact Person Email
- dmoro-sibilot@chu-grenoble.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medical oncology
- Principal Investigator Name
- Sandrine HIRET
- Principal Investigator Email
- sandrine.hiret@ico.unicancer.fr
- Contact Person Name
- Sandrine HIRET
- Contact Person Email
- sandrine.hiret@ico.unicancer.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Multidisciplinary oncology and therapeutic innovations
- 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
Germany
- Earliest CTIS Part Ii Submission Date
- 03-11-2025
- Latest Decision Or Authorization Date
- 28-11-2025
- Processing Time Days
- 25
- Number Of Sites
- 4
- Number Of Participants
- 9
Sites
- Site Name
- Klinikum Der Landeshauptstadt Stuttgart gKAöR
- Department Name
- Klinikum Stuttgart - Katharinenhospital, Innere Medizin
- Principal Investigator Name
- Markus Knott
- Principal Investigator Email
- m.knott@klinikum-stuttgart.de
- Contact Person Name
- Markus Knott
- Contact Person Email
- m.knott@klinikum-stuttgart.de
- Site Name
- Knappschaft Kliniken MVZ Nord GmbH
- Principal Investigator Name
- Till-Oliver Emde
- Principal Investigator Email
- emde@oncologianova.de
- Contact Person Name
- Till-Oliver Emde
- Contact Person Email
- emde@oncologianova.de
- Site Name
- ST. ELISABETH-KRANKENHAUS LEIPZIG gGmbH des Katholischen Kirchenlehens St. Trinitatis
- Department Name
- Abteilung für Pneumologie
- Principal Investigator Name
- Sylvia Gütz
- Principal Investigator Email
- sylvia.guetz@ek-leipzig.de
- Contact Person Name
- Sylvia Gütz
- Contact Person Email
- sylvia.guetz@ek-leipzig.de
- Site Name
- LMU Klinikum Muenchen AöR
- Department Name
- Medizinische Klinik und Poliklinik 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
Greece
- Earliest CTIS Part Ii Submission Date
- 15-09-2025
- Latest Decision Or Authorization Date
- 02-12-2025
- Processing Time Days
- 78
- Number Of Sites
- 5
- Number Of Participants
- 17
Sites
- Site Name
- Athens Medical Center S.A.
- Department Name
- 4th Department of Medical Oncology
- Principal Investigator Name
- Ippokratis Korantzis
- Principal Investigator Email
- ippokratis.korantzis@gmail.com
- Contact Person Name
- Ippokratis Korantzis
- Contact Person Email
- ippokratis.korantzis@gmail.com
- Site Name
- Metaxa Cancer Center Hospital Of Piraeus
- Department Name
- Department of Medical Oncology & Hematopoietic Cell Transplant Unit
- Principal Investigator Name
- Christos Kosmas
- Principal Investigator Email
- ckosmas1@hotmail.com
- Contact Person Name
- Christos Kosmas
- Contact Person Email
- ckosmas1@hotmail.com
- Site Name
- Thoracic General Hospital Of Athens I Sotiria
- Department Name
- Oncology Unit, 3rd Dpt of Internal Medicine and Laboratory
- 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
- Ioannis Mountzios
- Principal Investigator Email
- gmountzios@gmail.com
- Contact Person Name
- Ioannis Mountzios
- Contact Person Email
- gmountzios@gmail.com
- Site Name
- Theageneio Cancer Hospital
- Department Name
- Pulmonary Oncology Department
- Principal Investigator Name
- Theodora Tsiouda
- Principal Investigator Email
- doratsiouda@yahoo.gr
- Contact Person Name
- Theodora Tsiouda
- Contact Person Email
- doratsiouda@yahoo.gr
Italy
- Earliest CTIS Part Ii Submission Date
- 31-10-2025
- Latest Decision Or Authorization Date
- 28-11-2025
- Processing Time Days
- 28
- Number Of Sites
- 5
- Number Of Participants
- 13
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Operative Unit of Oncology and Hematology
- Principal Investigator Name
- Armando Santoro
- Principal Investigator Email
- armando.santoro@cancercenter.humanitas.it
- Contact Person Name
- Armando Santoro
- Contact Person Email
- armando.santoro@cancercenter.humanitas.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Oncology
- Principal Investigator Name
- Emilio Bria
- Principal Investigator Email
- emilio.bria@policlinicogemelli.it
- Contact Person Name
- Emilio Bria
- Contact Person Email
- emilio.bria@policlinicogemelli.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- SCDU Medical Oncology
- 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
- Istituto Oncologico Veneto
- Department Name
- Oncology 2
- Principal Investigator Name
- Laura Bonanno
- Principal Investigator Email
- laura.bonanno@iov.veneto.it
- Contact Person Name
- Laura Bonanno
- Contact Person Email
- laura.bonanno@iov.veneto.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- Medical Oncology
- Principal Investigator Name
- Chiara Bennati
- Principal Investigator Email
- chiara.bennati@auslromagna.it
- Contact Person Name
- Chiara Bennati
- Contact Person Email
- chiara.bennati@auslromagna.it
Portugal
- Earliest CTIS Part Ii Submission Date
- 13-11-2025
- Latest Decision Or Authorization Date
- 03-12-2025
- Processing Time Days
- 20
- Number Of Sites
- 7
- Number Of Participants
- 14
Sites
- Site Name
- Unidade Local De Saude Do Alto Ave E.P.E.
- Department Name
- Oncology
- Principal Investigator Name
- Pedro Ulisses
- Principal Investigator Email
- pedroulisses@ulsaave.min-saude.pt
- Contact Person Name
- Pedro Ulisses
- Contact Person Email
- pedroulisses@ulsaave.min-saude.pt
- Site Name
- Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
- Department Name
- Oncology
- Principal Investigator Name
- Marta Soares
- Principal Investigator Email
- martasoares@ipoporto.min-saude.pt
- Contact Person Name
- Marta Soares
- Contact Person Email
- martasoares@ipoporto.min-saude.pt
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Oncology
- Principal Investigator Name
- Raquel Pereira
- Principal Investigator Email
- maria.araujo.pereira@ulsb.min-saude.pt
- Contact Person Name
- Raquel Pereira
- Contact Person Email
- maria.araujo.pereira@ulsb.min-saude.pt
- Site Name
- Unidade Local De Saude De Gaia/Espinho E.P.E.
- Department Name
- Oncology
- Principal Investigator Name
- Ana Barroso
- Principal Investigator Email
- abarroso@CHVNG.MIN-SAUDE.PT
- Contact Person Name
- Ana Barroso
- Contact Person Email
- abarroso@CHVNG.MIN-SAUDE.PT
- Site Name
- Hospital Cuf Tejo S.A.
- Department Name
- Oncology
- 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
- Unidade Local De Saude De Loures-Odivelas EPE
- Department Name
- Oncology
- Principal Investigator Name
- Joao Moreira Pinto
- Principal Investigator Email
- joao.ppinto@ulslod.min-saude.pt
- Contact Person Name
- Joao Moreira Pinto
- Contact Person Email
- joao.ppinto@ulslod.min-saude.pt
- Site Name
- CCAB Centro Clinico Academico Braga Associacao (duplicate listing in record)
- Department Name
- Oncology
- Principal Investigator Name
- Maria Araujo Pereira
- Principal Investigator Email
- maria.araujo.pereira@ulsb.min-saude.pt
- Contact Person Name
- Maria Araujo Pereira
- Contact Person Email
- maria.araujo.pereira@ulsb.min-saude.pt
Spain
- Earliest CTIS Part Ii Submission Date
- 03-11-2025
- Latest Decision Or Authorization Date
- 28-11-2025
- Processing Time Days
- 25
- Number Of Sites
- 6
- Number Of Participants
- 15
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- 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
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncology
- Principal Investigator Name
- Oscar Juan
- Principal Investigator Email
- juan_osc@gva.es
- Contact Person Name
- Oscar Juan
- Contact Person Email
- juan_osc@gva.es
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Oncology
- Principal Investigator Name
- Javier Alvarez
- Principal Investigator Email
- javier.alvarez.fernandez@sergas.es
- Contact Person Name
- Javier Alvarez
- Contact Person Email
- javier.alvarez.fernandez@sergas.es
- Site Name
- Hospital De Jerez De La Frontera
- Department Name
- Oncology
- Principal Investigator Name
- Jesus Jaime Corral
- Principal Investigator Email
- jesuscorraljaime@hotmail.com
- Contact Person Name
- Jesus Jaime Corral
- Contact Person Email
- jesuscorraljaime@hotmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Enriqueta Felip
- Principal Investigator Email
- efelip@vhio.net
- Contact Person Name
- Enriqueta Felip
- Contact Person Email
- efelip@vhio.net
- Site Name
- Hospital Universitario Y Politecnico La Fe (additional listing)
- Department Name
- Oncology
- Principal Investigator Name
- Juan Osc
- Principal Investigator Email
- juan_osc@gva.es
- Contact Person Name
- Juan Osc
- Contact Person Email
- juan_osc@gva.es
Poland
- Earliest CTIS Part Ii Submission Date
- 31-10-2025
- Latest Decision Or Authorization Date
- 30-11-2025
- Processing Time Days
- 30
- Number Of Sites
- 5
- Number Of Participants
- 13
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Onkologii i Radioterapii
- Principal Investigator Name
- Katarzyna Szymczak
- Principal Investigator Email
- kszymczak@uck.gda.pl
- Contact Person Name
- Katarzyna Szymczak
- Contact Person Email
- kszymczak@uck.gda.pl
- Site Name
- Centrum Pulmonologii I Torakochirurgii W Bystrej
- Department Name
- Oddzial Pulmonologiczno-Onkologiczny z Chemioterapia
- Principal Investigator Name
- Beata Kania-Zembaczynska
- Principal Investigator Email
- bzembaczynska@gmail.com
- Contact Person Name
- Beata Kania-Zembaczynska
- Contact Person Email
- bzembaczynska@gmail.com
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Ambulatorium Chemoterapii
- Principal Investigator Name
- Bogdan Zurawski
- Principal Investigator Email
- bzur1@wp.pl
- Contact Person Name
- Bogdan Zurawski
- Contact Person Email
- bzur1@wp.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworow 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
- Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
- Department Name
- Oddzial Onkologii z Pododdzialem 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
Sponsor
Primary sponsor
- Full Name
- Janssen Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Labcorp Central Laboratory Services SARL
- Responsibilities
- sponsorDuties code: 4
- Name
- 4g Clinical LLC
- Responsibilities
- sponsorDuties code: 3
Third parties
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- JNJ-73841937
- Active Substance
- LAZERTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Authorised (prodAuthStatus=1)
- Investigational Product Name
- JNJ-61186372
- Active Substance
- AMIVANTAMAB
- Modality
- Other antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- SUBCUTANEOUS USE
- Authorisation Status
- Authorised (prodAuthStatus=1)
- Combination Treatment
- Yes
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