Clinical trial • Phase II/III • Oncology

Izalontamab brengitecan for Non-small cell lung cancer (EGFR-mutated)

Phase II/III trial of Izalontamab brengitecan for Non-small cell lung cancer (EGFR-mutated).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer (EGFR-mutated)
Trial Stage
Phase II/III
Drug Modality
ADC|Small molecule|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
12-09-2025
First CTIS Authorization Date
19-01-2026

Trial design

Randomised, open-label, platinum-based doublet chemotherapy: pemetrexed (500 mg/m2 iv) in combination with either cisplatin (75 mg/m2 iv) or carboplatin (up to 750 mg iv) (exact schedule per local soc).-controlled, adaptive Phase II/III trial across 67 sites in Belgium, France, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
Platinum-based doublet chemotherapy: pemetrexed (500 mg/m2 IV) in combination with either cisplatin (75 mg/m2 IV) or carboplatin (up to 750 mg IV) (exact schedule per local SOC).
Adaptive
True, Phase 2 includes dose-finding to determine the RP3D for izalontamab brengitecan based on safety, tolerability, efficacy, and PK/PD data (dose escalation/determination implied; specific escalation rules not provided in the available data).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
403

Eligibility

Recruits 403 No vulnerable populations selected (isVulnerablePopulationSelected: false). No assent/minor consent procedures described in the submission; informed consent from adult participants is indicated via provided ICFs..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). No assent/minor consent procedures described in the submission; informed consent from adult participants is indicated via provided ICFs.

Inclusion criteria

  • {"criterion_text":"- Non-squamous NSCLC, not amenable to treatment in curative intent."}
  • {"criterion_text":"- Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation)."}
  • {"criterion_text":"- Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting."}
  • {"criterion_text":"- Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed)."}

Exclusion criteria

  • {"criterion_text":"- Inadequate organ function and/or bone marrow reserve."}
  • {"criterion_text":"- Leptomeningeal metastases or spinal cord compression."}
  • {"criterion_text":"- Poorly controlled systemic medical conditions."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Phase 2: RP3D determined based on the totality of safety, tolerability, efficacy, and PK/pharmacodynamic data","definition_or_measurement_approach":"RP3D determined based on the totality of safety, tolerability, efficacy, and PK/pharmacodynamic data."}
  • {"endpoint_text":"- Phase 3: progression-free survival by RECIST v1.1 per Blinded Independent Central Review.","definition_or_measurement_approach":"Progression-free survival assessed by RECIST v1.1 as evaluated by a Blinded Independent Central Review."}

Secondary endpoints

  • {"endpoint_text":"- Phase 2: Overall Survival by RECIST v1.1 per Blinded Independent Central Review","definition_or_measurement_approach":"Overall survival assessed per RECIST v1.1 by Blinded Independent Central Review."}
  • {"endpoint_text":"- Phase 2: Progression-Free Survival rates by RECIST v1.1 per Blinded Independent Central Review","definition_or_measurement_approach":"Progression-free survival rates by RECIST v1.1 as assessed by Blinded Independent Central Review."}
  • {"endpoint_text":"- Phase 3: overall survival (OS).","definition_or_measurement_approach":"Overall survival (OS) measured as time from randomisation to death from any cause."}

Recruitment

Planned Sample Size
403
Recruitment Window Months
64
Consent Approach
Written informed consent obtained from participants. Subject information and informed consent forms (ICFs) and related documents are provided in multiple country-specific versions and languages (examples in the submission include EN, FR, DE, DU/NL, ES, IT, PL, NO, GR). Separate ICFs for pregnant partners/participants and optional sample/future research are included; no assent procedures for minors are described.

Geography

Total Number Of Sites
67
Total Number Of Participants
193

Belgium

Earliest CTIS Part Ii Submission Date
28-11-2025
Latest Decision Or Authorization Date
21-01-2026
Processing Time Days
54
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Chirec
Department Name
Respiratory Diseases
Principal Investigator Name
Christophe Compere
Principal Investigator Email
christophe.compere@chirec.be
Contact Person Name
Christophe Compere
Contact Person Email
christophe.compere@chirec.be
Site Name
Vitaz
Department Name
Pulmonary and Infectious Disease
Principal Investigator Name
Koenraad Deschepper
Principal Investigator Email
koen.deschepper@vitaz.be
Contact Person Name
Koenraad Deschepper
Contact Person Email
koen.deschepper@vitaz.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Thoracic Oncology and Interventional Pneumology
Principal Investigator Name
Sebahat Ocak
Principal Investigator Email
sebahat.ocak@chuuclnamur.uclouvain.be
Contact Person Name
Sebahat Ocak
Site Name
Ziekenhuis Aan De Stroom
Department Name
Pulmonology
Principal Investigator Name
Charlotte De Bondt
Principal Investigator Email
charlotte.debondt@zas.be
Contact Person Name
Charlotte De Bondt
Contact Person Email
charlotte.debondt@zas.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Respiratory Medicine/Thoracic Oncology
Principal Investigator Name
Veerle Surmont
Principal Investigator Email
veerle.surmont@uzgent.be
Contact Person Name
Veerle Surmont
Contact Person Email
veerle.surmont@uzgent.be

France

Earliest CTIS Part Ii Submission Date
17-11-2025
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
70
Number Of Sites
10
Number Of Participants
20

Sites

Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Medical Oncology
Principal Investigator Name
Elvire Pons-Tostivint
Principal Investigator Email
elvire.pons@chu-nantes.fr
Contact Person Name
Elvire Pons-Tostivint
Contact Person Email
elvire.pons@chu-nantes.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
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
Thoracic Oncology
Principal Investigator Name
Laurent Greillier
Principal Investigator Email
laurent.greillier@ap-hm.fr
Contact Person Name
Laurent Greillier
Contact Person Email
laurent.greillier@ap-hm.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Penumology
Principal Investigator Name
Céline Mascaux
Principal Investigator Email
celine.mascaux@chru-strasbourg.fr
Contact Person Name
Céline Mascaux
Site Name
Hospices Civils De Lyon
Department Name
Pneumology
Principal Investigator Name
Thomas Pierret
Principal Investigator Email
thomas.pierret@chu-lyon.fr
Contact Person Name
Thomas Pierret
Contact Person Email
thomas.pierret@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Pneumology
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
Hopital Tenon
Department Name
Pneumology
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
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 De Toulouse
Department Name
Pneumology
Principal Investigator Name
Julier Mazieres
Principal Investigator Email
Mazieres.j@chu-toulouse.fr
Contact Person Name
Julier Mazieres
Contact Person Email
Mazieres.j@chu-toulouse.fr

Germany

Earliest CTIS Part Ii Submission Date
08-12-2025
Latest Decision Or Authorization Date
21-01-2026
Processing Time Days
44
Number Of Sites
11
Number Of Participants
30

Sites

Site Name
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
Department Name
Klinik für Pneumologie
Principal Investigator Name
Christian Grohé
Principal Investigator Email
christian.grohe@jsd.de
Contact Person Name
Christian Grohé
Contact Person Email
christian.grohe@jsd.de
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
MVZ Onkologie Barmbek
Principal Investigator Name
Robert Erdmann
Principal Investigator Email
r.erdmann@asklepios.com
Contact Person Name
Robert Erdmann
Contact Person Email
r.erdmann@asklepios.com
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinik für Innere Medizin IV
Principal Investigator Name
Stefan Hammerschmidt
Principal Investigator Email
s.hammerschmidt@skc.de
Contact Person Name
Stefan Hammerschmidt
Contact Person Email
s.hammerschmidt@skc.de
Site Name
Kliniken der Stadt Koeln gGmbH
Department Name
Thoraxonkologie
Principal Investigator Name
Eva Lotte Buchmeier
Principal Investigator Email
BuchmeierE@kliniken-koeln.de
Contact Person Name
Eva Lotte Buchmeier
Contact Person Email
BuchmeierE@kliniken-koeln.de
Site Name
Onkologie Donauwoerth (MVZ) GmbH
Department Name
Onkologisches Zentrum Donauwörth
Principal Investigator Name
Bastian Fleischmann
Principal Investigator Email
b.fleischmann_stu@onko-medeor.de
Contact Person Name
Bastian Fleischmann
Site Name
Klinikum Kassel GmbH
Department Name
Hämatologie, Onkologie und Immunologie
Principal Investigator Name
Daniela Dörfel
Principal Investigator Email
Daniela.doerfel@gnh.net
Contact Person Name
Daniela Dörfel
Contact Person Email
Daniela.doerfel@gnh.net
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Innere Medizin II
Principal Investigator Name
Matthias Ritgen
Principal Investigator Email
matthias.ritgen@uksh.de
Contact Person Name
Matthias Ritgen
Contact Person Email
matthias.ritgen@uksh.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Innere Medizin II
Principal Investigator Name
Gerlinde Schmidtke-Schrezenmeier
Contact Person Name
Gerlinde Schmidtke-Schrezenmeier
Site Name
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
Department Name
Robert-Bosch-Krankenhaus (RBK)
Principal Investigator Name
Martin Kimmich
Principal Investigator Email
martin.kimmich@rbk.de
Contact Person Name
Martin Kimmich
Contact Person Email
martin.kimmich@rbk.de
Site Name
Asklepios Klinik Gauting GmbH
Department Name
Onkologisches Studienzentrum
Principal Investigator Name
Niels Reinmuth
Principal Investigator Email
n.reinmuth@asklepios.com
Contact Person Name
Niels Reinmuth
Contact Person Email
n.reinmuth@asklepios.com
Site Name
Klinikum Esslingen GmbH
Department Name
Klinik für Kardiologie, Angiologie und Pneumologie
Principal Investigator Name
Martin Faehling
Principal Investigator Email
m.faehling@klinikum-esslingen.de
Contact Person Name
Martin Faehling

Greece

Earliest CTIS Part Ii Submission Date
25-09-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
116
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Theageneio Cancer Hospital
Department Name
Pulmonological-Oncological Department
Principal Investigator Name
Theodora Tsiouda
Principal Investigator Email
dora.tsiouda@yahoo.gr
Contact Person Name
Theodora Tsiouda
Contact Person Email
dora.tsiouda@yahoo.gr
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd Department of Internal Medicine, Oncology Unit & 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
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Pulmonary Clinic of Aristotle University of Thessaloniki
Principal Investigator Name
Dionisios Gerasimos Spyratos
Principal Investigator Email
diospyrato@yahoo.com
Contact Person Name
Dionisios Gerasimos Spyratos
Contact Person Email
diospyrato@yahoo.com
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Propaedeutic department of Internal Medicine
Principal Investigator Name
Amanda Psyrri
Principal Investigator Email
ogkologiko@hotmail.com
Contact Person Name
Amanda Psyrri
Contact Person Email
ogkologiko@hotmail.com

Italy

Earliest CTIS Part Ii Submission Date
25-09-2025
Latest Decision Or Authorization Date
21-01-2026
Processing Time Days
118
Number Of Sites
7
Number Of Participants
25

Sites

Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Dip Onco-Ematologico
Principal Investigator Name
Manolo D'Arcangelo
Principal Investigator Email
manolo.darcangelo@auslromagna.it
Contact Person Name
Manolo D'Arcangelo
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Thoracic Medical Oncology
Principal Investigator Name
Alessandro Morabito
Principal Investigator Email
a.morabito@istitutotumori.na.it
Contact Person Name
Alessandro Morabito
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
SCDU _Medicai 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
AORN San Giuseppe Moscati Avellino
Department Name
U.O. Oncology
Principal Investigator Name
Paolo Maione
Principal Investigator Email
pmaione@libero.it
Contact Person Name
Paolo Maione
Contact Person Email
pmaione@libero.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
S.0.C. Oncologia medica e dei tumori immuno-correlati
Principal Investigator Name
Alessandra Bearz
Principal Investigator Email
abearz@cro.it
Contact Person Name
Alessandra Bearz
Contact Person Email
abearz@cro.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Thoracic Oncology Division
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 Ospedaliero Universitaria Parma
Department Name
Medical Oncology
Principal Investigator Name
Marcello Tiseo
Principal Investigator Email
mtiseo@ao.pr.it
Contact Person Name
Marcello Tiseo
Contact Person Email
mtiseo@ao.pr.it

Romania

Earliest CTIS Part Ii Submission Date
03-12-2025
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
54
Number Of Sites
9
Number Of Participants
24

Sites

Site Name
Institutul Regional De Oncologie Iasi
Department Name
Oncology
Principal Investigator Name
Dana Clement
Principal Investigator Email
manager@iroiasi.ro
Contact Person Name
Dana Clement
Contact Person Email
manager@iroiasi.ro
Site Name
Centrul De Oncologie-Euroclinic S.R.L.
Department Name
Oncology
Principal Investigator Name
Constantin Volovat
Principal Investigator Email
cvolovat@yahoo.com
Contact Person Name
Constantin Volovat
Contact Person Email
cvolovat@yahoo.com
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncology
Principal Investigator Name
Michael Schenker
Principal Investigator Email
office@centruldeoncologie.ro
Contact Person Name
Michael Schenker
Contact Person Email
office@centruldeoncologie.ro
Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Oncology
Principal Investigator Name
Andrei Ungureanu
Principal Investigator Email
andrei.ungureanu@amethyst-radiotherapy.com
Contact Person Name
Andrei Ungureanu
Site Name
Memorial Healthcare International S.R.L.
Department Name
Oncology
Principal Investigator Name
Ingrid Adriana Iordan
Principal Investigator Email
mireliordan@yahoo.com
Contact Person Name
Ingrid Adriana Iordan
Contact Person Email
mireliordan@yahoo.com
Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
Oncology
Principal Investigator Name
Aurelia Alexandru
Principal Investigator Email
auralexandru@yahoo.com
Contact Person Name
Aurelia Alexandru
Contact Person Email
auralexandru@yahoo.com
Site Name
Centrul De Diagnostic Si Tratament Provita S.A.
Department Name
Oncology
Principal Investigator Name
Mircea Dediu
Principal Investigator Email
dr.mdediu@gmail.com
Contact Person Name
Mircea Dediu
Contact Person Email
dr.mdediu@gmail.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncology
Principal Investigator Name
Tudor Eliade Ciuleanu
Principal Investigator Email
office@iocn.ro
Contact Person Name
Tudor Eliade Ciuleanu
Contact Person Email
office@iocn.ro
Site Name
Other listed Romanian site

Spain

Earliest CTIS Part Ii Submission Date
03-12-2025
Latest Decision Or Authorization Date
21-01-2026
Processing Time Days
49
Number Of Sites
12
Number Of Participants
36

Sites

Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology
Principal Investigator Name
Margarita Majem
Principal Investigator Email
mmajem@santpau.cat
Contact Person Name
Margarita Majem
Contact Person Email
mmajem@santpau.cat
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Principal Investigator Name
Manuel Cobo-Dols
Principal Investigator Email
xxx.xxx@xxx.es
Contact Person Name
Manuel Cobo-Dols
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Principal Investigator Email
xxx.xxx@xxx.es
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Principal Investigator Name
Javier Torres-Jimenez
Principal Investigator Email
xxx.xxx@xxx.es
Contact Person Name
Javier Torres-Jimenez
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital Universitario Virgen Del Rocio S.L.
Department Name
Oncology
Principal Investigator Name
Reyes Bernabé Caro
Principal Investigator Email
bernabeensayos@gmail.com
Contact Person Name
Reyes Bernabé Caro
Contact Person Email
bernabeensayos@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Laura Masfarre
Principal Investigator Email
lauramasfarre@vhio.net
Contact Person Name
Laura Masfarre
Contact Person Email
lauramasfarre@vhio.net
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncology
Principal Investigator Name
Mariano Provencio
Principal Investigator Email
mprovencio.ensayosclinicos@gmail.com
Contact Person Name
Thomas Provencio
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Principal Investigator Name
Oscar Juan Vidal
Principal Investigator Email
juan_osc@gva.es
Contact Person Name
Oscar Juan Vidal
Contact Person Email
juan_osc@gva.es
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Oncology
Principal Investigator Name
Dolores Isla Casado
Principal Investigator Email
xxx.xxx@xxx.es
Contact Person Name
Dolores Isla Casado
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital Universitario La Paz
Department Name
Oncology
Principal Investigator Name
Javier De Castro
Principal Investigator Email
javier.decastro@salud.madrid.org
Contact Person Name
Javier De Castro
Site Name
Other listed Spanish site
Site Name
Other listed Spanish site 2

Norway

Earliest CTIS Part Ii Submission Date
17-12-2025
Latest Decision Or Authorization Date
22-01-2026
Processing Time Days
36
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Helse Bergen HF
Department Name
Thoracic Medicine
Principal Investigator Name
Øystein Fløtten
Principal Investigator Email
oystein.flotten@helse-bergen.no
Contact Person Name
Øystein Fløtten
Site Name
Oslo University Hospital HF
Department Name
Department of Oncology
Principal Investigator Name
Åsa Kristina Öjlert
Principal Investigator Email
aasojl@ous-hf.no
Contact Person Name
Åsa Kristina Öjlert
Contact Person Email
aasojl@ous-hf.no
Site Name
Vestre Viken HF
Department Name
Department of Oncology
Principal Investigator Name
Odd Terje Brustugun
Principal Investigator Email
otr@vestreviken.no
Contact Person Name
Odd Terje Brustugun
Contact Person Email
otr@vestreviken.no

Poland

Earliest CTIS Part Ii Submission Date
08-12-2025
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
49
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Odział 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
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Principal Investigator Name
Bogdan Żurawski
Principal Investigator Email
zurawski@co.bydgoszcz.pl
Contact Person Name
Bogdan Żurawski
Contact Person Email
zurawski@co.bydgoszcz.pl
Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
Oddział Onkologii i Radioterapii
Principal Investigator Name
Joanna Pikiel
Principal Investigator Email
joanna.pikiel@post.pl
Contact Person Name
Joanna Pikiel
Contact Person Email
joanna.pikiel@post.pl

Netherlands

Earliest CTIS Part Ii Submission Date
25-09-2025
Latest Decision Or Authorization Date
28-01-2026
Processing Time Days
125
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Amsterdam UMC Stichting
Department Name
Lung
Principal Investigator Name
Sayed Mohammad Shah Hashemi
Principal Investigator Email
research.longgeneeskunde@amsterdamumc.nl
Contact Person Name
Sayed Mohammad Shah Hashemi
Site Name
Ziekenhuis St Jansdal
Department Name
Lung
Principal Investigator Name
Lisenka Boom
Principal Investigator Email
LN.Boom@stjansdal.nl
Contact Person Name
Lisenka Boom
Contact Person Email
LN.Boom@stjansdal.nl
Site Name
Netherlands Cancer Institute
Department Name
Lung
Principal Investigator Name
Sushil Koewarsingh Badrising
Principal Investigator Email
m.mahn@nki.nl
Contact Person Name
Sushil Koewarsingh Badrising
Contact Person Email
m.mahn@nki.nl

Sponsor

Primary sponsor

Full Name
Bristol-Myers Squibb Services Unlimited Company
Organisation Type
Pharmaceutical company
Country Of Registered Address
Ireland

Contract research organisations

Name
Labcorp Central Laboratory Services LP
Responsibilities
Central Lab; Kit Build; IHC Testing; Data Management
Name
Labcorp Central Laboratory Services SARL
Responsibilities
Central Lab; Kit Build; IHC Testing; Data Management
Name
Pharmaceutical Product Development LLC
Responsibilities
PK and IMG Analysis
Name
Bioclinica Inc.
Responsibilities
Medical image analysis/ review - X-ray, MRI, ultrasound, etc. Central Imaging.

Third parties

  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Lab; Kit Build; IHC Testing; Data Management","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements, electronic study-related communications to patients","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Licensing and translation services","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central Lab; Kit Build; IHC Testing; Data Management","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Data Management Platform","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"PRO/eCOA","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"PK and IMG Analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"Singapore","full_name":"Labcorp Development (Asia) Pte Ltd","duties_or_roles":"Central Lab; Kit Build; IHC Testing; Data Management","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc. Central Imaging.","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Illumina Inc.","duties_or_roles":"Plasma ctDNA analysis","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long term sample storage","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
BL-B01D1
Active Substance
Izalontamab brengitecan
Modality
ADC
Routes Of Administration
Intravenous
Route
Intravenous
Investigational Product Name
PEMETREXED
Active Substance
Pemetrexed
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Starting Dose
500 mg/m2 (max daily dose amount reported)
Maximum Dose
9999 (product record)
Investigational Product Name
CISPLATIN
Active Substance
Cisplatin
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Starting Dose
75 mg/m2 (max daily dose amount reported)
Maximum Dose
300 mg/m2 (max total dose amount reported)
Investigational Product Name
CARBOPLATIN
Active Substance
Carboplatin
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Starting Dose
750 mg (max daily dose amount reported)
Maximum Dose
3000 mg (max total dose amount reported)
Investigational Product Name
PEGFILGRASTIM
Active Substance
Pegfilgrastim
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Starting Dose
6 mg (max daily dose amount reported)
Maximum Dose
9999 (product record)
Combination Treatment
Yes

Related trials

Other published trials that may interest you.