Clinical trial • Phase II/III • Oncology

2-[4-[4-(aminomethyl)-1-oxo-2h-phthalazin-6-yl]-2-methylpyrazol-3-yl]-4-chloro-6-cyclopropyloxy-3-fluorobenzonitrile for Metastatic non-small cell lung cancer

Phase II/III trial of 2-[4-[4-(aminomethyl)-1-oxo-2h-phthalazin-6-yl]-2-methylpyrazol-3-yl]-4-chloro-6-cyclopropyloxy-3-fluorobenzonitrile for Metastatic…

Overview

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

Key dates

Initial CTIS Submission Date
14-07-2025
First CTIS Authorization Date
24-10-2025

Trial design

Randomised, placebo plus pembrolizumab and chemotherapy (placebo = mrtx1719 matching placebo). chemotherapy agents listed in the protocol include carboplatin, cisplatin, pemetrexed, paclitaxel and paclitaxel albumin-bound; specific doses/schedules are not specified in the ctis extract.-controlled, adaptive Phase II/III trial across 86 sites in Austria, Belgium, Bulgaria and others.

Randomised
Yes
Comparator
Placebo plus pembrolizumab and chemotherapy (placebo = MRTX1719 Matching Placebo). Chemotherapy agents listed in the protocol include carboplatin, cisplatin, pemetrexed, paclitaxel and paclitaxel albumin-bound; specific doses/schedules are not specified in the CTIS extract.
Adaptive
True, Dose selection is indicated (trial scope includes 'Dose selection' / Phase 2 dose selection). Specific dose-escalation rules or interim/stopping rules are not provided in the CTIS extract.
Biomarker Stratified
True, biomarker: homozygous MTAP deletion / MTAP loss (participants selected based on MTAP homozygous deletion).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
389

Eligibility

Recruits 389 Vulnerable populations were not selected for inclusion (isVulnerablePopulationSelected=false). Participants must be ≥18 years (or legal age of consent) and provide written informed consent. No assent requirements are specified (adult-only population). Subject information and ICF documents are provided in multiple country/language versions..

Vulnerable Population
Vulnerable populations were not selected for inclusion (isVulnerablePopulationSelected=false). Participants must be ≥18 years (or legal age of consent) and provide written informed consent. No assent requirements are specified (adult-only population). Subject information and ICF documents are provided in multiple country/language versions.

Inclusion criteria

  • {"criterion_text":"- Participants must be aged ≥ 18 years (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF."}
  • {"criterion_text":"- Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease."}
  • {"criterion_text":"- Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase MTAP deletion or MTAP loss."}
  • {"criterion_text":"- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1."}
  • {"criterion_text":"- Participants must have at least 1 measurable lesion as per RECIST v1.1."}

Exclusion criteria

  • {"criterion_text":"- Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy."}
  • {"criterion_text":"- Participants must not have symptomatic brain metastases or spinal cord compression."}
  • {"criterion_text":"- Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC). Note: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated."}
  • {"criterion_text":"- Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Phase 2: Progression free survival (PFS) by RECIST v1.1","definition_or_measurement_approach":"Progression-free survival assessed per RECIST v1.1."}
  • {"endpoint_text":"- Phase 3: Progression free survival (PFS) by RECIST v1.1","definition_or_measurement_approach":"Progression-free survival assessed per RECIST v1.1."}
  • {"endpoint_text":"- Phase 3: overall survival (OS).","definition_or_measurement_approach":"Overall survival measured as time from randomization to death from any cause."}

Secondary endpoints

  • {"endpoint_text":"- Phase 2: objective response (OR), disease control (DC), time to objective response (TTOR), and duration of response (DOR)by RECIST v1.1","definition_or_measurement_approach":"Objective response, disease control, time to objective response and duration of response assessed per RECIST v1.1."}
  • {"endpoint_text":"- Phase 3: objective response (OR), disease control (DC), time to objective response (TTOR), duration of response (DOR), progression free survival (PFS) and PFS2 by RECIST v1.1","definition_or_measurement_approach":"Responses and PFS measures assessed per RECIST v1.1; PFS2 as defined in protocol."}
  • {"endpoint_text":"- Phase 2: Treatment-related and all-cause adverse events (AEs), serious AEs (including fatal AEs); AEs leading to dose interruption, dose reduction, and study treatment discontinuation and laboratory abnormalities","definition_or_measurement_approach":"Safety assessed by collection of AEs, SAEs, dose modifications and laboratory abnormalities per standard definitions."}

Recruitment

Planned Sample Size
389
Recruitment Window Months
69
Consent Approach
Written informed consent from participants (participants must be ≥18 years or legal age of consent). ICF and subject information documents exist in multiple country/language versions (examples: English, French, German, Dutch, Spanish and country-specific ICFs are listed in the documents). No assent process described (adult-only population). Specific local consent language availability is provided via country ICF documents.

Methods

  • Site-based recruitment materials: country-specific patient invite letters, posters and brochures (documents labelled as K2_Recruitment material, Patient Poster, Patient Brochure, and K1_Recruitment Arrangement Form are present for multiple countries).
  • Third-party patient recruitment: Massive Bio Inc. listed with sponsor duty 'Patient recruitment'.
  • Central laboratory and sample services supporting recruitment/assessments (LabCorp, Azenta, Discovery Life Sciences) and CRO support (IQVIA, PPD) are noted and may support site operations and recruitment logistics.

Geography

Total Number Of Sites
86
Total Number Of Participants
191

Austria

Earliest CTIS Part Ii Submission Date
14-10-2025
Latest Decision Or Authorization Date
27-10-2025
Processing Time Days
13
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
Department of Internal Medicine and Pneumology
Principal Investigator Name
Maximilian Hochmair
Principal Investigator Email
maximilian.hochmair@gesundheitsverbund.at
Contact Person Name
Maximilian Hochmair
Site Name
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Department Name
Department of Oncology
Principal Investigator Name
Thomas Winder
Principal Investigator Email
thomas.winder@lkhf.at
Contact Person Name
Thomas Winder
Contact Person Email
thomas.winder@lkhf.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Department of Pneumology
Principal Investigator Name
Michael Schumacher
Principal Investigator Email
michael.schumacher@ordensklinikum.at
Contact Person Name
Michael Schumacher

Belgium

Earliest CTIS Part Ii Submission Date
08-10-2025
Latest Decision Or Authorization Date
30-10-2025
Processing Time Days
22
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Centre hospitalier universitaire de Liege
Department Name
Medical Oncology
Principal Investigator Name
Pierre Freres
Principal Investigator Email
pfreres@chuliege.be
Contact Person Name
Pierre Freres
Contact Person Email
pfreres@chuliege.be
Site Name
UZ Brussel
Department Name
Medical Oncology
Principal Investigator Name
Lore Decoster
Principal Investigator Email
lore.decoster@uzbrussel.be
Contact Person Name
Lore Decoster
Contact Person Email
lore.decoster@uzbrussel.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Pneumology
Principal Investigator Name
Ingel Demedts
Principal Investigator Email
ingel.demedts@azdelta.be
Contact Person Name
Ingel Demedts
Contact Person Email
ingel.demedts@azdelta.be
Site Name
University Hospital Antwerp
Department Name
Pulmonary Medecine_Thoracic oncology
Principal Investigator Name
Jo Raskin
Principal Investigator Email
jo.raskin@uza.be
Contact Person Name
Jo Raskin
Contact Person Email
jo.raskin@uza.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

Bulgaria

Earliest CTIS Part Ii Submission Date
03-11-2025
Latest Decision Or Authorization Date
07-11-2025
Processing Time Days
4
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Department Name
Department – Medical Oncology Level III
Principal Investigator Name
Rositsa Krasteva
Principal Investigator Email
uni@unihospitalbg.bg
Contact Person Name
Rositsa Krasteva
Contact Person Email
uni@unihospitalbg.bg
Site Name
University Multidisciplinary Hospital For Active Treatment Sveta Ekaterina EAD
Department Name
Department – Medical Oncology Level III
Principal Investigator Name
Galina Kurteva
Principal Investigator Email
info@uhsek.com
Contact Person Name
Galina Kurteva
Contact Person Email
info@uhsek.com
Site Name
Complex Oncology Center Ruse EOOD
Department Name
Department – Medical Oncology Level II
Principal Investigator Name
Nikolay Evgeniev
Principal Investigator Email
kocruse@abv.bg
Contact Person Name
Nikolay Evgeniev
Contact Person Email
kocruse@abv.bg
Site Name
MBAL Trakia EOOD
Department Name
Department – Medical Oncology Level III
Principal Investigator Name
Rumyana Ilieva
Principal Investigator Email
contacts@trakiahospital.com
Contact Person Name
Rumyana Ilieva
Contact Person Email
contacts@trakiahospital.com
Site Name
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Department Name
Department – Medical Oncology Level III
Principal Investigator Name
Kremena Vasileva
Principal Investigator Email
xxxx@xxxx.com
Contact Person Name
Kremena Vasileva
Contact Person Email
xxxx@xxxx.com
Site Name
Specialized Hospital For Active Treatment Of Oncology Haskovo EOOD
Department Name
Department – Medical Oncology Level II
Principal Investigator Name
Stoil Boychev
Principal Investigator Email
xxxx@xxxx.com
Contact Person Name
Stoil Boychev
Contact Person Email
xxxx@xxxx.com

Czechia

Earliest CTIS Part Ii Submission Date
23-10-2025
Latest Decision Or Authorization Date
03-11-2025
Processing Time Days
11
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Plicni klinika
Principal Investigator Name
Michal Hrnciarik
Principal Investigator Email
michal.hrnciarik@fnhk.cz
Contact Person Name
Michal Hrnciarik
Contact Person Email
michal.hrnciarik@fnhk.cz
Site Name
University Hospital Olomouc
Department Name
Klinika plicnich nemoci a tuberkulozy
Principal Investigator Name
Juraj Kultan
Principal Investigator Email
juraj.kultan@fnol.cz
Contact Person Name
Juraj Kultan
Contact Person Email
juraj.kultan@fnol.cz

Denmark

Earliest CTIS Part Ii Submission Date
13-10-2025
Latest Decision Or Authorization Date
31-10-2025
Processing Time Days
18
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Copenhagen University Hospital
Department Name
Department of Oncology
Principal Investigator Name
Edyta Maria Urbanska
Principal Investigator Email
edyta.maria.Urbanska@regionh.dk
Contact Person Name
Edyta Maria Urbanska

France

Earliest CTIS Part Ii Submission Date
20-10-2025
Latest Decision Or Authorization Date
03-11-2025
Processing Time Days
14
Number Of Sites
15
Number Of Participants
32

Sites

Site Name
GROUPE HOSPITALIER PARIS SAINT JOSEPH
Department Name
Pneumonology
Principal Investigator Name
Carole HELISSEY DANIS
Principal Investigator Email
chelissey@ghpsj.fr
Contact Person Name
Carole HELISSEY DANIS
Contact Person Email
chelissey@ghpsj.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Pneumonology
Principal Investigator Name
Julien MAZIERES
Principal Investigator Email
mazieresjulien@gmail.com
Contact Person Name
Julien MAZIERES
Contact Person Email
mazieresjulien@gmail.com
Site Name
CHRU De Nancy
Department Name
Pneumonology
Principal Investigator Name
Bertrand MENNECIER
Principal Investigator Email
b.mennecier@chru-nancy.fr
Contact Person Name
Bertrand MENNECIER
Contact Person Email
b.mennecier@chru-nancy.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Pneumonology
Principal Investigator Name
Gilles QUERE
Principal Investigator Email
gilles.quere@chu-brest.fr
Contact Person Name
Gilles QUERE
Contact Person Email
gilles.quere@chu-brest.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Pneumonology
Principal Investigator Name
Eric PICHON
Principal Investigator Email
e.pichon@chu-tours.fr
Contact Person Name
Eric PICHON
Contact Person Email
e.pichon@chu-tours.fr
Site Name
CHU Gabriel-Montpied
Department Name
Pneumonology
Principal Investigator Name
Patrick MERLE
Principal Investigator Email
pmerle@chu-clermontferrand.fr
Contact Person Name
Patrick MERLE
Contact Person Email
pmerle@chu-clermontferrand.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Pneumonology
Principal Investigator Name
Remi VEILLON
Principal Investigator Email
remi.veillon@chu-bordeaux.fr
Contact Person Name
Remi VEILLON
Contact Person Email
remi.veillon@chu-bordeaux.fr
Site Name
Institut Paoli Calmettes
Department Name
Pneumonology
Principal Investigator Name
Anne MADROSZYK
Principal Investigator Email
madroszyka@ipc.unicancer.fr
Contact Person Name
Anne MADROSZYK
Contact Person Email
madroszyka@ipc.unicancer.fr
Site Name
Centre Hospitalier Regional Universitaire De Rennes
Department Name
Pneumonology
Principal Investigator Name
Charles RICORDEL
Principal Investigator Email
charles.ricordel@chu-rennes.fr
Contact Person Name
Charles RICORDEL
Contact Person Email
charles.ricordel@chu-rennes.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Pneumonology
Principal Investigator Name
Coureche KADERBHAI
Principal Investigator Email
cgkaderbhai@cgfl.fr
Contact Person Name
Coureche KADERBHAI
Contact Person Email
cgkaderbhai@cgfl.fr
Site Name
Institut Curie
Department Name
Pneumonology
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 Francois Baclesse
Department Name
Pneumonology
Principal Investigator Name
Hubert CURCIO
Principal Investigator Email
h.curcio@baclesse.unicancer.fr
Contact Person Name
Hubert CURCIO
Contact Person Email
h.curcio@baclesse.unicancer.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Pneumonology
Principal Investigator Name
Quentin THOMAS
Principal Investigator Email
quentin.thomas@icm.unicancer.fr
Contact Person Name
Quentin THOMAS
Site Name
Centre Hospitalier Regional Universitaire
Department Name
Pneumonology
Principal Investigator Name
Virginie WESTEEL
Principal Investigator Email
virginie.westeel@univ-fcomte.fr
Contact Person Name
Virginie WESTEEL
Site Name
Hospices Civils De Lyon
Department Name
Pneumonology
Principal Investigator Name
Michael DURUISSEAUX
Principal Investigator Email
michael.duruisseaux@chu-lyon.fr
Contact Person Name
Michael DURUISSEAUX

Germany

Earliest CTIS Part Ii Submission Date
20-10-2025
Latest Decision Or Authorization Date
24-10-2025
Processing Time Days
4
Number Of Sites
9
Number Of Participants
30

Sites

Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
Medizinische Klinik II Onkologie / Krebsheilkunde mit Palliativmedizin
Principal Investigator Name
Jonas Kuon
Principal Investigator Email
jonas.kuon@slk-kliniken.de
Contact Person Name
Jonas Kuon
Contact Person Email
jonas.kuon@slk-kliniken.de
Site Name
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH
Department Name
Klinik für Onkologie und Hämatologie
Principal Investigator Name
Bernhard Braun
Principal Investigator Email
bernhard.braun@barmherzige-regensburg.de
Contact Person Name
Bernhard Braun
Site Name
Bundeswehrkrankenhaus Ulm
Department Name
Schwerpunkt Hämatologie und Onkologie
Principal Investigator Name
Matthias Mueller
Principal Investigator Email
matthias27mueller@bundeswehr.org
Contact Person Name
Matthias Mueller
Site Name
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
Department Name
Abteilung für Pneumologische Onkologie
Principal Investigator Name
Martin Kimmich
Principal Investigator Email
martin.kimmich@klinik-schillerhoehe.de
Contact Person Name
Martin Kimmich
Site Name
Lungenfachklinik Immenhausen
Department Name
Thoraxonkologie
Principal Investigator Name
Achim Rittmeyer
Contact Person Name
Achim Rittmeyer
Site Name
LungenClinic Grosshansdorf GmbH
Department Name
Onkologie
Principal Investigator Name
Martin Reck
Principal Investigator Email
m.reck@lungenclinic.de
Contact Person Name
Martin Reck
Contact Person Email
m.reck@lungenclinic.de
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
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Klinik und Poliklinik fuer Innere Medizin III - Hämatologie und Onkologie
Principal Investigator Name
Folker Schneller
Principal Investigator Email
folker.schneller@mri.tum.de
Contact Person Name
Folker Schneller
Contact Person Email
folker.schneller@mri.tum.de
Site Name
Alb Fils Kliniken GmbH
Department Name
Zentrum für Hämatologische Neoplasien
Principal Investigator Name
Martin Bommer
Principal Investigator Email
martin.bommer@af-k.de
Contact Person Name
Martin Bommer
Contact Person Email
martin.bommer@af-k.de

Greece

Earliest CTIS Part Ii Submission Date
31-10-2025
Latest Decision Or Authorization Date
12-11-2025
Processing Time Days
12
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Alexandra Hospital
Department Name
Oncology Department
Principal Investigator Name
Michalis Liontos
Principal Investigator Email
mliontos@gmail.gr
Contact Person Name
Michalis Liontos
Contact Person Email
mliontos@gmail.gr
Site Name
General University Hospital Of Patras
Department Name
Division of Oncology, Department of Medicine
Principal Investigator Name
Angelos Koutras
Principal Investigator Email
angkoutr@otenet.gr
Contact Person Name
Angelos Koutras
Contact Person Email
angkoutr@otenet.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
Henry Dunant Hospital Center
Department Name
4th Department of Oncology & 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
3rd Department of Oncology Clinic
Principal Investigator Name
Anastasios Boutis
Principal Investigator Email
alboutis@yahoo.com
Contact Person Name
Anastasios Boutis
Contact Person Email
alboutis@yahoo.com
Site Name
General University Hospital Of Larissa
Department Name
Oncology Clinic, Chemotherapy Department
Principal Investigator Name
Athanasios Kotsakis
Principal Investigator Email
kotsakisthan@gmail.com
Contact Person Name
Athanasios Kotsakis
Contact Person Email
kotsakisthan@gmail.com

Hungary

Earliest CTIS Part Ii Submission Date
17-10-2025
Latest Decision Or Authorization Date
10-11-2025
Processing Time Days
24
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Matrai Gyogyintezet
Department Name
Bronchologiai osztaly
Principal Investigator Name
Albert Istvan
Principal Investigator Email
foigazgato@magy.eu
Contact Person Name
Albert Istvan
Contact Person Email
foigazgato@magy.eu
Site Name
Clinic Of Pulmonology Semmelweis University
Department Name
Pulmonológiai Klinika
Principal Investigator Name
Veronika Muller
Principal Investigator Email
muller.veronika@semmelweis.hu
Contact Person Name
Veronika Muller
Contact Person Email
muller.veronika@semmelweis.hu
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
Tudogyogyaszat es legzesrehabilitacios osztaly
Principal Investigator Name
Ibolya Laczo
Principal Investigator Email
laczoibolya@gmail.com
Contact Person Name
Ibolya Laczo
Contact Person Email
laczoibolya@gmail.com
Site Name
Farkasgyepui Tudogyogyintezet
Department Name
I. pulmonologia
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

Italy

Earliest CTIS Part Ii Submission Date
19-09-2025
Latest Decision Or Authorization Date
12-11-2025
Processing Time Days
54
Number Of Sites
8
Number Of Participants
16

Sites

Site Name
Ospedale Santa Maria Della Misericordia - Azienda Ospedaliera di Perugia
Department Name
Medical Oncology
Principal Investigator Name
Giulio Metro
Principal Investigator Email
giulio.metro@unipg.it
Contact Person Name
Giulio Metro
Contact Person Email
giulio.metro@unipg.it
Site Name
IRCCS - Ospedale San Raffaele
Department Name
Medical Oncology
Principal Investigator Name
Alessandra Bulotta
Principal Investigator Email
bulotta.alessandra@hsr.it
Contact Person Name
Alessandra Bulotta
Contact Person Email
bulotta.alessandra@hsr.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Clinical 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 Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
UOC Oncoematologia
Principal Investigator Name
Floriana Morgillo
Principal Investigator Email
floriana.morgillo@unicampania.it
Contact Person Name
Floriana Morgillo
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
Oncologia Polmonare
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
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Oncology-Hematology
Principal Investigator Name
Francesco Gelsomino
Principal Investigator Email
francesco_gelsomino@aosp.bo.it
Contact Person Name
Francesco Gelsomino
Contact Person Email
francesco_gelsomino@aosp.bo.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Medical Oncology 1
Principal Investigator Name
Claudia Proto
Principal Investigator Email
claudia.proto@istitutotumori.mi.it
Contact Person Name
Claudia Proto
Site Name
Ospedale Santa Maria delle Croci
Department Name
Oncology
Principal Investigator Name
Manolo D'Arcangelo
Principal Investigator Email
manolo.darcangelo@auslromagna.it
Contact Person Name
Manolo D'Arcangelo

Netherlands

Earliest CTIS Part Ii Submission Date
16-10-2025
Latest Decision Or Authorization Date
31-10-2025
Processing Time Days
15
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Pulmonology
Principal Investigator Name
Thijo (Jeroen) Hiltermann
Principal Investigator Email
t.j.n.hiltermann@umcg.nl
Contact Person Name
Thijo (Jeroen) Hiltermann
Contact Person Email
t.j.n.hiltermann@umcg.nl

Poland

Earliest CTIS Part Ii Submission Date
09-10-2025
Latest Decision Or Authorization Date
07-11-2025
Processing Time Days
29
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Lux Med Onkologia Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej/Chemioterapii
Principal Investigator Name
Ewa Salt
Principal Investigator Email
ewa.salt@luxmed.pl
Contact Person Name
Ewa Salt
Contact Person Email
ewa.salt@luxmed.pl
Site Name
Pratia S.A. (Cracow)
Principal Investigator Name
Anna Drosik-Kwaśniewska
Principal Investigator Email
adrosik-kwasniewska@pratia.pl
Contact Person Name
Anna Drosik-Kwaśniewska
Contact Person Email
adrosik-kwasniewska@pratia.pl
Site Name
Pratia S.A. (Poznan)
Principal Investigator Name
Marek Kotlarski
Principal Investigator Email
marek.kotlarski@pratia.com
Contact Person Name
Marek Kotlarski
Contact Person Email
marek.kotlarski@pratia.com
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Principal Investigator Name
Bogdan Żurawski
Principal Investigator Email
zurawskib@co.bydgoszcz.pl
Contact Person Name
Bogdan Żurawski
Contact Person Email
zurawskib@co.bydgoszcz.pl
Site Name
Szpital Specjalistyczny W Prabutach Sp. z o.o.
Department Name
Oddział Pulmonologii
Principal Investigator Name
Anna Łowczak
Principal Investigator Email
sekretariat@szpitalprabuty.pl
Contact Person Name
Anna Łowczak
Contact Person Email
sekretariat@szpitalprabuty.pl
Site Name
Mazowiecki Szpital Onkologiczny Sp. z o.o.
Department Name
Poradnia Onkologiczna
Principal Investigator Name
Renata Biernacka
Principal Investigator Email
a.jackowska@szpitalonkologiczny.pl
Contact Person Name
Renata Biernacka

Romania

Earliest CTIS Part Ii Submission Date
03-10-2025
Latest Decision Or Authorization Date
27-10-2025
Processing Time Days
24
Number Of Sites
10
Number Of Participants
20

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
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncology
Principal Investigator Name
Tudor Ciuleanu
Principal Investigator Email
office@iocn.ro
Contact Person Name
Tudor Ciuleanu
Contact Person Email
office@iocn.ro
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
Spitalul Municipal Ploiesti
Department Name
Oncology
Principal Investigator Name
Amedeia Nita
Principal Investigator Email
spitalschuller@yahoo.com
Contact Person Name
Amedeia Nita
Contact Person Email
spitalschuller@yahoo.com
Site Name
Centrul De Oncologie-Euroclinic S.R.L.
Department Name
Oncology
Principal Investigator Name
Constantin Volovat
Principal Investigator Email
abc@yahoo.com
Contact Person Name
Constantin Volovat
Contact Person Email
abc@yahoo.com
Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
Oncology
Principal Investigator Name
Aurelia Alexandru
Principal Investigator Email
secretariat@iob.ro
Contact Person Name
Aurelia Alexandru
Contact Person Email
secretariat@iob.ro
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncology
Principal Investigator Name
Cristina Ligia Cebotaru
Principal Investigator Email
office@iocn.ro
Contact Person Name
Cristina Ligia Cebotaru
Contact Person Email
office@iocn.ro
Site Name
Centrul De Diagnostic Si Tratament Provita S.A.
Department Name
Oncology
Principal Investigator Name
Mircea Dediu
Principal Investigator Email
abc@yahoo.com
Contact Person Name
Mircea Dediu
Contact Person Email
abc@yahoo.com
Site Name
Radiology Therapeutic Center S.R.L.
Department Name
Oncology
Principal Investigator Name
Elena Ciubotaru
Principal Investigator Email
office.cluj@amethyst-radiotherapy.com
Contact Person Name
Elena Ciubotaru
Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Oncology
Principal Investigator Name
Andrei Ungureanu
Principal Investigator Email
office.cluj@amethyst-radiotherapy.com
Contact Person Name
Andrei Ungureanu

Spain

Earliest CTIS Part Ii Submission Date
08-10-2025
Latest Decision Or Authorization Date
29-10-2025
Processing Time Days
21
Number Of Sites
9
Number Of Participants
20

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Principal Investigator Name
Luis Paz-Ares
Principal Investigator Email
xxx@xxx.com
Contact Person Name
Luis Paz-Ares
Contact Person Email
xxx@xxx.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 General Universitario Gregorio Maranon
Department Name
Oncology
Principal Investigator Name
Antonio Calles
Principal Investigator Email
xxx@xxx.com
Contact Person Name
Antonio Calles
Contact Person Email
xxx@xxx.com
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncology
Principal Investigator Name
Mariano Provencio
Principal Investigator Email
xxx@xxx.com
Contact Person Name
Mariano Provencio
Contact Person Email
xxx@xxx.com
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
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Principal Investigator Name
Reyes Bernabe
Principal Investigator Email
xxx@xxx.com
Contact Person Name
Reyes Bernabe
Contact Person Email
xxx@xxx.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Principal Investigator Name
Ernest Nadal
Principal Investigator Email
esnadal@iconcologia.net
Contact Person Name
Ernest Nadal
Contact Person Email
esnadal@iconcologia.net
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Principal Investigator Name
Alexandra Cantero
Principal Investigator Email
xxx@xxx.com
Contact Person Name
Alexandra Cantero
Contact Person Email
xxx@xxx.com
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda (additional listing)
Department Name
Oncology
Principal Investigator Name
Mariano Provencio
Principal Investigator Email
xxx@xxx.com
Contact Person Name
Mariano Provencio
Contact Person Email
xxx@xxx.com

Sweden

Earliest CTIS Part Ii Submission Date
24-09-2025
Latest Decision Or Authorization Date
12-11-2025
Processing Time Days
49
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Klinisk prövningsenhet, Verksamhet onkologi, Blå Stråket 2, 413 45 Göteborg
Principal Investigator Name
Andreas Hallqvist
Principal Investigator Email
andreas.hallqvist@vgregion.se
Contact Person Name
Andreas Hallqvist
Contact Person Email
andreas.hallqvist@vgregion.se

Sponsor

Primary sponsor

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

Contract research organisations

Name
Iqvia Inc.
Responsibilities
Site payments; regulatory support for PSA submission in EU/EEA, UK and Turkey
Name
Pharmaceutical Product Development LLC (PPD)
Responsibilities
PK analysis

Third parties

  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long-term sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long-term sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Site payments; regulatory support for PSA submission in EU/EEA, UK and Turkey","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Discovery Life Sciences Biomarker Services GmbH","duties_or_roles":"Samples and whole transcriptome sequencing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"PK analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Mural Health Technologies Inc.","duties_or_roles":"Clinical Trial Payment - Subject Reimbursement and Financial Services; provides travel arrangements","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Routine clinical pathology testing; LabCorp Central Lab","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Massive Bio Inc.","duties_or_roles":"Patient recruitment","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MRTX1719
Active Substance
2-[4-[4-(aminomethyl)-1-oxo-2h-phthalazin-6-yl]-2-methylpyrazol-3-yl]-4-chloro-6-cyclopropyloxy-3-fluorobenzonitrile
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Investigational Product Name
MRTX1719 Matching Placebo
Modality
Other
Investigational Product Name
PEMBROLIZUMAB
Active Substance
pembrolizumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENUS USE
Route
INTRAVENOUS
Investigational Product Name
CARBOPLATIN
Active Substance
carboplatin
Modality
Small molecule
Routes Of Administration
INTRAVENUS USE
Route
INTRAVENOUS
Investigational Product Name
CISPLATIN
Active Substance
cisplatin
Modality
Small molecule
Routes Of Administration
INTRAVENUS USE
Route
INTRAVENOUS
Maximum Dose
75 mg/m2
Investigational Product Name
PEMETREXED
Active Substance
pemetrexed
Modality
Small molecule
Routes Of Administration
INTRAVENUS USE
Route
INTRAVENOUS
Maximum Dose
500 mg/m2
Investigational Product Name
PACLITAXEL
Active Substance
paclitaxel
Modality
Small molecule
Routes Of Administration
INTRAVENUS USE
Route
INTRAVENOUS
Maximum Dose
200 mg/m2
Investigational Product Name
PACLITAXEL ALBUMIN-BOUND
Active Substance
paclitaxel albumin-bound
Modality
Small molecule
Routes Of Administration
INTRAVENUS USE
Route
INTRAVENOUS
Maximum Dose
100 mg/m2
Combination Treatment
Yes

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