Clinical trial • Phase II/III • Oncology

TELISOTUZUMAB ADIZUTECAN for Non-small cell lung cancer

Phase II/III trial of TELISOTUZUMAB ADIZUTECAN for Non-small cell lung cancer.

Overview

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

Key dates

Initial CTIS Submission Date
30-09-2025
First CTIS Authorization Date
09-02-2026

Trial design

Randomised, open-label, osimertinib; amivantamab; carboplatin; pemetrexed; cisplatin (doses and schedules not specified in provided data)-controlled, adaptive Phase II/III trial in Austria, Belgium, France and others.

Randomised
Yes
Open Label
Yes
Comparator
OSIMERTINIB; AMIVANTAMAB; CARBOPLATIN; PEMETREXED; CISPLATIN (doses and schedules not specified in provided data)
Adaptive
True - Phase 2 includes dose finding to select the recommended phase 3 dose (RP3D); detailed escalation rules/interim analysis/stopping rules not provided in the available documents.
Biomarker Stratified
True, biomarker: c-Met immunohistochemistry (IHC) status (strata not specified)
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
56

Stratification factors

  • c-Met immunohistochemistry (IHC) status (used for study stratification in Phase 2)

Eligibility

Recruits 56 No vulnerable population selected (isVulnerablePopulationSelected=false). Public title and documents specify adult participants. Standard informed consent from participants is required; no assent process for minors is described in the submitted data..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected=false). Public title and documents specify adult participants. Standard informed consent from participants is required; no assent process for minors is described in the submitted data.

Inclusion criteria

  • {"criterion_text":"- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation as detected by an Federal 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- Provide archived or recently obtained tumor tissue during Screening for c-Met immunohistochemistry (IHC) testing (and study stratification in Phase 2).\n- Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the adjuvant, locally advanced, or metastatic setting, either as monotherapy or in combination with other agents, and experienced documented radiographic disease progression on or after therapy for the most recent regimen administered prior to study entry.\n- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n- At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated.\n- Central nervous system (CNS) metastasis, these should be clinically asymptomatic or stable after definitive treatment.\n- Current, historical, or suspected interstitial lung disease (ILD)/pneumonitis that required steroids should be excluded."}

Exclusion criteria

  • {"criterion_text":"- Received more than 1 line of systemic therapy in the locally advanced or metastatic setting.\n- Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Phase 2: Objective Response (OR) Assessed by Blinded Independent Central Review (BICR)","definition_or_measurement_approach":"Objective Response (OR) assessed by Blinded Independent Central Review (BICR). (Phase 2 primary endpoint measured by BICR)"}
  • {"endpoint_text":"- Phase 3: Progression-Free Survival (PFS) as assessed by BICR","definition_or_measurement_approach":"Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)."}

Secondary endpoints

  • {"endpoint_text":"- Phase 2 and 3: Overall Survival (OS) as assessed by BICR","definition_or_measurement_approach":"Overall Survival (OS) assessed by Blinded Independent Central Review (BICR)."}
  • {"endpoint_text":"- Phase 2: PFS as assessed by BICR","definition_or_measurement_approach":"Progression-Free Survival (PFS) assessed by BICR (Phase 2)."}
  • {"endpoint_text":"- Phase 2 and 3: Duration of Response (DoR) as Assessed by the BICR per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1","definition_or_measurement_approach":"Duration of Response (DoR) assessed by BICR according to RECIST v1.1."}
  • {"endpoint_text":"- Phase 2 and 3: Disease Control (DC) as Assessed by the BICR per RECIST v1.1","definition_or_measurement_approach":"Disease Control (DC) assessed by BICR per RECIST v1.1."}
  • {"endpoint_text":"- Phase 3: OR Assessed by BICR","definition_or_measurement_approach":"Objective Response (OR) assessed by BICR (Phase 3)."}
  • {"endpoint_text":"- Phase 3: Percentage of Participants with Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)","definition_or_measurement_approach":"Change from baseline in Physical Functioning measured using EORTC QLQ-C30."}
  • {"endpoint_text":"- Phase 3: Percentage of Participants with Change from Baseline in Key Lung Cancer Symptoms as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQLC13)","definition_or_measurement_approach":"Change from baseline in key lung cancer symptoms measured by EORTC QLQ-LC13."}
  • {"endpoint_text":"- Phase 3: Percentage of Participants with Change from Baseline in GHS/QoL as measured by the EORTC QLQ-C30","definition_or_measurement_approach":"Change from baseline in global health status/quality of life (GHS/QoL) measured by EORTC QLQ-C30."}
  • {"endpoint_text":"- Phase 3: Percentage of Participants with Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)","definition_or_measurement_approach":"Change from baseline in Physical Functioning measured using EORTC QLQ-C30 (duplicate entry present in source)."}

Recruitment

Planned Sample Size
56
Recruitment Window Months
39
Consent Approach
Informed consent required from adult participants. Subject information and ICF documents are provided (country-specific main ICFs and addenda), including pregnancy-specific ICFs and addenda. ICFs available in multiple languages across countries (examples in submitted documents: German, French, Dutch, English, Portuguese, Spanish, Polish). No assent process for minors is described in the submitted data.

Geography

Total Number Of Sites
57
Total Number Of Participants
56

Austria

Earliest CTIS Part Ii Submission Date
15-01-2026
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
32
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
Klinik Floridsdorf - Abteilung fuer Innere Medizin und Pneumologie
Principal Investigator Name
Maximilian Hochmair
Principal Investigator Email
maximilian.hochmair@gesundheitsverbund.at
Contact Person Name
Maximilian Hochmair

Belgium

Earliest CTIS Part Ii Submission Date
27-01-2026
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
14
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
CHC MontLegia
Department Name
Oncology
Principal Investigator Name
Maryam Bourhaba
Principal Investigator Email
maryam.bourhaba@chc.be
Contact Person Name
Maryam Bourhaba
Contact Person Email
maryam.bourhaba@chc.be
Site Name
UZ Leuven
Department Name
Respiratory Oncology Unit
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
Grand Hopital De Charleroi
Department Name
Oncology& Hematology
Principal Investigator Name
Benoit Colinet
Principal Investigator Email
benoit.colinet2@ghdc.be
Contact Person Name
Benoit Colinet
Contact Person Email
benoit.colinet2@ghdc.be
Site Name
Institut Jules Bordet
Department Name
Oncology
Principal Investigator Name
Bogdan Grigoriu
Principal Investigator Email
bogdan.grigoriu@hubruxelles.be
Contact Person Name
Bogdan Grigoriu
Contact Person Email
bogdan.grigoriu@hubruxelles.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

France

Earliest CTIS Part Ii Submission Date
16-01-2026
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
31
Number Of Sites
9
Number Of Participants
6

Sites

Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical oncology
Principal Investigator Name
Judith Raimbourg
Principal Investigator Email
judith.raimbourg@ico.unicancer.fr
Contact Person Name
Judith Raimbourg
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Thoracic Oncology
Principal Investigator Name
Patricia BARRE
Principal Investigator Email
p-barre@chu-montpellier.fr
Contact Person Name
Patricia BARRE
Contact Person Email
p-barre@chu-montpellier.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Oncology
Principal Investigator Name
Margaux Geier
Principal Investigator Email
margaux.geier@chu-brest.fr
Contact Person Name
Margaux Geier
Contact Person Email
margaux.geier@chu-brest.fr
Site Name
Institut Curie
Department Name
Pneumology
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
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Pole thorax et Vaisseaux - Unité d'Oncologie Thoracique
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 Gustave Roussy
Department Name
Medical Oncology
Principal Investigator Name
David Planchard
Principal Investigator Email
david.planchard@gustaveroussy.fr
Contact Person Name
David Planchard
Site Name
Centre Hospitalier Regional De Marseille
Department Name
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
Centre Hospitalier Universitaire De Lille
Department Name
Pulmonology and Thoracic Oncology
Principal Investigator Name
Alexis Cortot
Principal Investigator Email
alexis.cortot@chru-lille.fr
Contact Person Name
Alexis Cortot
Contact Person Email
alexis.cortot@chru-lille.fr
Site Name
Fondation IRCCS San Gerardo Dei Tintori
Department Name
Oncology
Principal Investigator Name
Diego Cortinovis
Principal Investigator Email
diegoluigi.cortinovis@irccs-sangerardo.it
Contact Person Name
Diego Cortinovis

Germany

Earliest CTIS Part Ii Submission Date
29-01-2026
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
12
Number Of Sites
6
Number Of Participants
4

Sites

Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Oncology
Principal Investigator Name
Helge Bischoff
Contact Person Name
Helge Bischoff
Site Name
Universitaetsklinikum Jena KöR
Department Name
Oncology
Principal Investigator Name
Jakob Hammersen
Principal Investigator Email
Kim2-studienzentrale@med.uni-jena.de
Contact Person Name
Jakob Hammersen
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Oncology
Principal Investigator Name
Maximilian Christopeit
Principal Investigator Email
m.christopeit@uke.de
Contact Person Name
Maximilian Christopeit
Contact Person Email
m.christopeit@uke.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Oncology
Principal Investigator Name
Pius Jung
Principal Investigator Email
ISZ_Koordination@ukw.de
Contact Person Name
Pius Jung
Contact Person Email
ISZ_Koordination@ukw.de
Site Name
Universitaetsklinikum Koeln AöR
Department Name
Oncology
Principal Investigator Name
Sebastian Michels
Principal Investigator Email
lungenkrebs@uk-koeln.de
Contact Person Name
Sebastian Michels
Contact Person Email
lungenkrebs@uk-koeln.de
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Oncology
Principal Investigator Name
Thomas Wehler
Principal Investigator Email
studienzentrum.oon@uk-gm.de
Contact Person Name
Thomas Wehler
Contact Person Email
studienzentrum.oon@uk-gm.de

Italy

Earliest CTIS Part Ii Submission Date
21-01-2026
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
21
Number Of Sites
10
Number Of Participants
9

Sites

Site Name
Ospedale Isola Tiberina Gemelli Isola
Department Name
Oncology
Principal Investigator Name
Emilio Bria
Principal Investigator Email
emilio.bria@policlinicogemelli.it
Contact Person Name
Emilio Bria
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Oncology
Principal Investigator Name
Antonio Passaro
Principal Investigator Email
antonio.passaro@ieo.it
Contact Person Name
Antonio Passaro
Contact Person Email
antonio.passaro@ieo.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
Oncology
Principal Investigator Name
Lorenzo Belluomini
Principal Investigator Email
lorenzo.belluomini@univr.it
Contact Person Name
Lorenzo Belluomini
Contact Person Email
lorenzo.belluomini@univr.it
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
Oncology
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
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Oncology
Principal Investigator Name
Federico Cappuzzo
Principal Investigator Email
federico.cappuzzo@ifo.it
Contact Person Name
Federico Cappuzzo
Contact Person Email
federico.cappuzzo@ifo.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
Oncology
Principal Investigator Name
Hector Soto Parra
Principal Investigator Email
hsotoparra@yahoo.it
Contact Person Name
Hector Soto Parra
Contact Person Email
hsotoparra@yahoo.it
Site Name
Azienda Sanitaria Territoriale Di Pesaro E Urbino
Department Name
Oncology
Principal Investigator Name
Rita Chiari
Principal Investigator Email
rita.chiari@sanita.marche.it
Contact Person Name
Rita Chiari
Contact Person Email
rita.chiari@sanita.marche.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Oncology
Principal Investigator Name
Alessandra Bearz
Principal Investigator Email
abearz@cro.it
Contact Person Name
Alessandra Bearz
Contact Person Email
abearz@cro.it
Site Name
Azienda Ospedaliera Dei Colli
Department Name
Oncology
Principal Investigator Name
Danilo Rocco
Principal Investigator Email
clinicaltrialsrocco@gmail.com
Contact Person Name
Danilo Rocco
Contact Person Email
clinicaltrialsrocco@gmail.com
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Oncology
Principal Investigator Name
Diego Cortinovis
Principal Investigator Email
diegoluigi.cortinovis@irccs-sangerardo.it
Contact Person Name
Diego Cortinovis

Portugal

Earliest CTIS Part Ii Submission Date
22-01-2026
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
18
Number Of Sites
6
Number Of Participants
6

Sites

Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Oncology
Principal Investigator Name
Pedro Costa
Principal Investigator Email
pedro.mn.costa@ulsb.min-saude.pt
Contact Person Name
Pedro Costa
Site Name
Hospital CUF Porto S.A.
Department Name
Oncology
Principal Investigator Name
Maria Fernanda Estevinho
Principal Investigator Email
fernandaestevinho@gmail.com
Contact Person Name
Maria Fernanda Estevinho
Contact Person Email
fernandaestevinho@gmail.com
Site Name
Unidade Local De Saude Do Alto Ave E.P.E.
Department Name
Pulmonology
Principal Investigator Name
Pedro Ulisses
Principal Investigator Email
pedroulisses@ulsaave.min-saude.pt
Contact Person Name
Pedro Ulisses
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Oncology
Principal Investigator Name
Marta Vilaca
Principal Investigator Email
marta.vilaca@ulsm.min-saude.pt
Contact Person Name
Marta Vilaca
Contact Person Email
marta.vilaca@ulsm.min-saude.pt
Site Name
Unidade Local De Saude De Loures-Odivelas EPE
Department Name
Oncology
Principal Investigator Name
Diana Silva
Principal Investigator Email
diana.neto.silva@ulslod.min-saude.pt
Contact Person Name
Diana Silva
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Oncology
Principal Investigator Name
Antonio Araujo
Principal Investigator Email
antonio.araujo@chporto.min-saude.pt
Contact Person Name
Antonio Araujo

Spain

Earliest CTIS Part Ii Submission Date
22-01-2026
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
25
Number Of Sites
8
Number Of Participants
8

Sites

Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology
Principal Investigator Name
Luis Angel Leon Mateos
Principal Investigator Email
luis.angel.leon.mateos@sergas.es
Contact Person Name
Luis Angel Leon Mateos
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Enriqueta Felip Font
Principal Investigator Email
efelip@vhio.net
Contact Person Name
Enriqueta Felip Font
Contact Person Email
efelip@vhio.net
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Principal Investigator Name
Pilar Garrido Lopez
Principal Investigator Email
pgarrido@salud.madrid.org
Contact Person Name
Pilar Garrido Lopez
Contact Person Email
pgarrido@salud.madrid.org
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Oncology
Principal Investigator Name
Elisa Quílez Bielsa
Principal Investigator Email
equilezb@salud.aragon.es
Contact Person Name
Elisa Quílez Bielsa
Contact Person Email
equilezb@salud.aragon.es
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Oncologist
Principal Investigator Name
Jose Carlos Benitez
Principal Investigator Email
Josecarlos.benitez@ibima.eu
Contact Person Name
Jose Carlos Benitez
Contact Person Email
Josecarlos.benitez@ibima.eu
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Principal Investigator Name
Paloma Martin Martorell
Principal Investigator Email
paloma_martin@comv.es
Contact Person Name
Paloma Martin Martorell
Contact Person Email
paloma_martin@comv.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
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
Parc Tauli Hospital Universitari
Department Name
Oncology
Principal Investigator Name
Laia Vila Martinez
Principal Investigator Email
lvila@tauli.cat
Contact Person Name
Laia Vila Martinez
Contact Person Email
lvila@tauli.cat

Netherlands

Earliest CTIS Part Ii Submission Date
22-01-2026
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
18
Number Of Sites
5
Number Of Participants
3

Sites

Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Longziekten
Principal Investigator Name
Egbert Smit
Principal Investigator Email
e.f.smit@lumc.nl
Contact Person Name
Egbert Smit
Contact Person Email
e.f.smit@lumc.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Longziekten
Principal Investigator Name
Sushil Koewarsingh Badrising
Principal Investigator Email
s.badrising@nki.nl
Contact Person Name
Sushil Koewarsingh Badrising
Contact Person Email
s.badrising@nki.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Longziekten
Principal Investigator Name
Marthe Paats
Principal Investigator Email
m.paats@erasmusmc.nl
Contact Person Name
Marthe Paats
Contact Person Email
m.paats@erasmusmc.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Divisie Hart en Longen
Principal Investigator Name
Anne van Lindert
Principal Investigator Email
a.s.r.vanlindert-2@umcutrecht.nl
Contact Person Name
Anne van Lindert
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Longziekten
Principal Investigator Name
Wouter van Geffen
Principal Investigator Email
wouter.vangeffen@radboudumc.nl
Contact Person Name
Wouter van Geffen
Contact Person Email
wouter.vangeffen@radboudumc.nl

Poland

Earliest CTIS Part Ii Submission Date
26-01-2026
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
21
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
Gyncentrum Sp. z o.o.
Principal Investigator Name
Adrianna Gega-Czarnota
Principal Investigator Email
a.gega-czarnota@holsaclinical.com
Contact Person Name
Adrianna Gega-Czarnota
Site Name
Provita Centrum Medyczne Sp. z o.o.
Principal Investigator Name
Magdalena Ciazynska
Principal Investigator Email
magdalena.ciazynska@nu-med.pl
Contact Person Name
Magdalena Ciazynska
Contact Person Email
magdalena.ciazynska@nu-med.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Oddzial Wieloprofilowy Zachowawczy
Principal Investigator Name
Izabela Chmielewska
Principal Investigator Email
izachm@wp.pl
Contact Person Name
Izabela Chmielewska
Contact Person Email
izachm@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
Pratia S.A.
Principal Investigator Name
Anna Drosik-Kwasniewska
Principal Investigator Email
adrosik-kwasniewska@pratia.pl
Contact Person Name
Anna Drosik-Kwasniewska
Contact Person Email
adrosik-kwasniewska@pratia.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Centrum Wsparcia Badan Klinicznych UCK, Osrodek Badan Klinicznych Wczesnych Faz
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
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Department Name
Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
Principal Investigator Name
Katarzyna Stencel
Principal Investigator Email
kstencel@wcpit.org
Contact Person Name
Katarzyna Stencel
Contact Person Email
kstencel@wcpit.org

Sponsor

Primary sponsor

Full Name
AbbVie Deutschland GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
IQVIA Limited
Responsibilities
Not specified (sponsorDuties code 3)
Name
Clario
Responsibilities
Central Imaging
Name
WCG Clinical Inc.
Responsibilities
External ILD Adjudication

Third parties

  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Subject Reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services Sàrl","duties_or_roles":"","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Clario","duties_or_roles":"Central Imaging","organisation_type":"Health care"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"External ILD Adjudication","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"eCOA/ ePRO","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Telisotuzumab adizutecan
Active Substance
TELISOTUZUMAB ADIZUTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
prodAuthStatus 1
Combination Treatment
Yes

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