Clinical trial • Phase III • Oncology|Respiratory

ADAGRASIB for Advanced non-small cell lung cancer

Phase III trial of ADAGRASIB for Advanced non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology|Respiratory
Trial Disease
Advanced non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
05-06-2024
First CTIS Authorization Date
11-07-2024

Trial design

Randomised, docetaxel (taxotere formulations), intravenous; dose unit mg/m2 (max daily amount listed as 75 mg/m2). specific schedule not specified in the available record.-controlled, crossover Phase III trial in Austria, Belgium, Czechia and others.

Randomised
Yes
Comparator
Docetaxel (TAXOTERE formulations), intravenous; dose unit mg/m2 (max daily amount listed as 75 mg/m2). Specific schedule not specified in the available record.
Crossover
Yes
Target Sample Size
90

Eligibility

Recruits 90 No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent is required from adult participants; no assent arrangements are described in the available record..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent is required from adult participants; no assent arrangements are described in the available record.

Inclusion criteria

  • {"criterion_text":"- Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation."}
  • {"criterion_text":"- Candidacy to receive treatment with docetaxel."}
  • {"criterion_text":"- Crossover Inclusion Criteria: Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR"}
  • {"criterion_text":"- Crossover Inclusion Criteria: ECOG performance status 0 - 2."}

Exclusion criteria

  • {"criterion_text":"- Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, sotorasib)."}
  • {"criterion_text":"- Active brain metastases"}
  • {"criterion_text":"- Crossover Exclusion Criteria: Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free Survival (PFS) Defined as time from randomization until disease progression or death from any cause, whichever occurs first.","definition_or_measurement_approach":"Defined as time from randomization until disease progression or death from any cause, whichever occurs first."}

Secondary endpoints

  • {"endpoint_text":"- Secondary efficacy endpoints:- Overall Survival (OS)− Objective Response Rate (ORR),− Duration of Response (DOR), and− 1-Year Survival Rate.","definition_or_measurement_approach":"Secondary efficacy endpoints include Overall Survival (OS), Objective Response Rate (ORR), Duration of Response (DOR), and 1-Year Survival Rate (as listed)."}
  • {"endpoint_text":"- Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events (AEs), laboratory abnormalities, and number of patients discontinuing study treatment due to an adverse event.","definition_or_measurement_approach":"Safety characterised by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, laboratory abnormalities, and number of patients discontinuing treatment due to an AE."}
  • {"endpoint_text":"- Population PK parameters of MRTX849.","definition_or_measurement_approach":"Population pharmacokinetic parameters for MRTX849 (PK analyses in study population)."}
  • {"endpoint_text":"- Patient Reported Outcome (PRO) scores using the following:− Lung Cancer Symptom Scale (LCSS), and− European Quality of Life Five Dimensions Questionnaire(EQ-5D-5L).","definition_or_measurement_approach":"PRO instruments specified: Lung Cancer Symptom Scale (LCSS) and EQ-5D-5L to assess HRQOL and cancer-specific symptoms."}

Recruitment

Planned Sample Size
90
Recruitment Window Months
65
Consent Approach
Informed consent obtained from adult participants using country-specific subject information and informed consent forms. Country-specific ICF documents are available (examples in the dossier: Italian, Greek, Portuguese, German, French, Dutch, Polish, Hungarian, Spanish, English). No further assent procedures described in the available record.

Geography

Total Number Of Sites
120
Total Number Of Participants
557

Austria

Latest Decision Or Authorization Date
16-07-2024
Number Of Sites
1
Number Of Participants
7

Sites

Site Name
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Principal Investigator Name
Barbara Mittergradnegger
Principal Investigator Email
barbara.mittergradnegger@kabeg.at
Contact Person Name
Barbara Mittergradnegger

Belgium

Latest Decision Or Authorization Date
12-07-2024
Number Of Sites
7
Number Of Participants
12

Sites

Site Name
Grand Hopital De Charleroi
Department Name
Medical Oncology
Principal Investigator Name
Jean-Luc Canon
Principal Investigator Email
jean-luc.canon@ghdc.be
Contact Person Name
Jean-Luc Canon
Contact Person Email
jean-luc.canon@ghdc.be
Site Name
Jessa Ziekenhuis
Department Name
Pulmonology
Principal Investigator Name
Kristof Cuppens
Principal Investigator Email
kristof.cuppens@jessazh.be
Contact Person Name
Kristof Cuppens
Contact Person Email
kristof.cuppens@jessazh.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Pulmonology
Principal Investigator Name
Sebahat Ocak
Principal Investigator Email
sebahat.ocak@uclouvain.be
Contact Person Name
Sebahat Ocak
Contact Person Email
sebahat.ocak@uclouvain.be
Site Name
Az Maria Middelares Gent
Department Name
Pulmonology
Principal Investigator Name
Paul Germonpré
Principal Investigator Email
paul.germonpre@azmmsj.be
Contact Person Name
Paul Germonpré
Contact Person Email
paul.germonpre@azmmsj.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
Pulmonology, Oncology
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
Antwerp University Hospital
Department Name
Pulmonology
Principal Investigator Name
Jo Raskin
Principal Investigator Email
jo.raskin@uza.be
Contact Person Name
Jo Raskin
Contact Person Email
jo.raskin@uza.be

Czechia

Latest Decision Or Authorization Date
16-07-2024
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
University Hospital Olomouc
Department Name
Klinika plicních nemocí a tuberkulózy
Principal Investigator Name
Juraj Kultan
Principal Investigator Email
juraj.kultan@fnol.cz
Contact Person Name
Juraj Kultan
Contact Person Email
juraj.kultan@fnol.cz

France

Latest Decision Or Authorization Date
12-07-2024
Number Of Sites
22
Number Of Participants
150

Sites

Site Name
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Department Name
Service Pneumologie
Principal Investigator Name
Didier DEBIEUVRE
Principal Investigator Email
debieuvred@ch-mulhouse.fr
Contact Person Name
Didier DEBIEUVRE
Contact Person Email
debieuvred@ch-mulhouse.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Service d'oncologie médicale
Principal Investigator Name
Ludovic DOUCET
Principal Investigator Email
ludovic.doucet@ico.unicancer.fr
Contact Person Name
Ludovic DOUCET
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Service de Pneumologie
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
Institut Gustave Roussy
Department Name
Pneumology
Principal Investigator Name
Fabrice BARLESI
Principal Investigator Email
fabrice.barlesi@gustaveroussy.fr
Contact Person Name
Fabrice BARLESI
Site Name
Hospices Civils De Lyon
Department Name
Service de Pneumologie
Principal Investigator Name
Michael DURUISSEAUX
Principal Investigator Email
michael.duruisseaux@chu-lyon.fr
Contact Person Name
Michael DURUISSEAUX
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Pneumology
Principal Investigator Name
Celine MASCAUX
Principal Investigator Email
celine.mascaux@chru-strasbourg.fr
Contact Person Name
Celine MASCAUX
Site Name
Hopital Cardiologique
Department Name
Pneumology 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
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Service de Pneumologie
Principal Investigator Name
Jeannick MADELAINE
Principal Investigator Email
madelaine-j@chu-caen.fr
Contact Person Name
Jeannick MADELAINE
Contact Person Email
madelaine-j@chu-caen.fr
Site Name
Centre Hospitalier Intercommunal De Cornouaille
Department Name
Thoracic Oncology
Principal Investigator Name
Romain CORRE
Principal Investigator Email
romain.corre@ch-cornouaille.fr
Contact Person Name
Romain CORRE
Contact Person Email
romain.corre@ch-cornouaille.fr
Site Name
Centre Francois Baclesse
Department Name
Respiratory Diseases and Thoracic Oncology
Principal Investigator Name
Radj GERVAIS
Principal Investigator Email
r.gervais@baclesse.fr
Contact Person Name
Radj GERVAIS
Contact Person Email
r.gervais@baclesse.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Unité d’Oncologie Thoracique
Principal Investigator Name
Alain VERGNENEGRE
Principal Investigator Email
alain.vergnenegre@chu-limoges.fr
Contact Person Name
Alain VERGNENEGRE
Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
Service de Pneumologie
Principal Investigator Name
Christos CHOUAID
Principal Investigator Email
christos.chouaid@chicreteil.fr
Contact Person Name
Christos CHOUAID
Contact Person Email
christos.chouaid@chicreteil.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service Pneumologie, Allergologie et oncologie thoracique
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
Institut de cancérologie
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 Georges Francois Leclerc
Department Name
Unité Fonctionnelle Oncologie
Principal Investigator Name
Coureche KADERBHAI
Principal Investigator Email
cgkaderbhai@cgfl.fr
Contact Person Name
Coureche KADERBHAI
Contact Person Email
cgkaderbhai@cgfl.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Pneumologie
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
Hospices Civils De Lyon (Bron)
Department Name
Service de Pneumologie
Principal Investigator Name
Michael DURUISSEAUX
Principal Investigator Email
michael.duruisseaux@chu-lyon.fr
Contact Person Name
Michael DURUISSEAUX
Site Name
Centre Regional Lutte Contre Le Cancer
Department Name
Oncologie médicale
Principal Investigator Name
Roland SCHOTT
Principal Investigator Email
r.schott@icans.eu
Contact Person Name
Roland SCHOTT
Contact Person Email
r.schott@icans.eu
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Oncologie Multidisciplinaire & 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
Les Hopitaux Nord-Ouest
Department Name
Service de Pneumologie
Principal Investigator Name
Lionel FALCHERO
Principal Investigator Email
lfalchero@lhopitalnordouest.fr
Contact Person Name
Lionel FALCHERO
Contact Person Email
lfalchero@lhopitalnordouest.fr

Germany

Latest Decision Or Authorization Date
16-07-2024
Number Of Sites
6
Number Of Participants
38

Sites

Site Name
Zentralklinik Bad Berka GmbH
Department Name
Klinik für Internistische Onkologie und Hämatologie
Principal Investigator Name
Ekkehard Eigendorff
Principal Investigator Email
ekkehard.eigendorff@zentralklinik.de
Contact Person Name
Ekkehard Eigendorff
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
Medizinische Klinik IV Organonkologie
Principal Investigator Name
Thomas Wehler
Principal Investigator Email
thomas.wehler@innere.med.uni-giessen.de
Contact Person Name
Thomas Wehler
Site Name
Muenchen Klinik gGmbH
Department Name
Klinik für Pneumologie und Pneumologische Onkologie
Principal Investigator Name
Konrad Kokowski
Principal Investigator Email
konrad.kokowski@klinikum-muenchen.de
Contact Person Name
Konrad Kokowski
Site Name
Sana Klinikum Offenbach GmbH
Department Name
Medizinische Klinik IV für Hämatologie und internistische Onkologie
Principal Investigator Name
Thomas Wehler
Principal Investigator Email
thomas.wehler@sana.de
Contact Person Name
Thomas Wehler
Contact Person Email
thomas.wehler@sana.de
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
SLK-Kliniken - Fachklinik Löwenstein
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
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Klinik für Internistische Onkologie/Hämatologie mit Integrierter Palliativmedizin
Principal Investigator Name
Almut Brundert
Principal Investigator Email
a.brundert@kem-med.com
Contact Person Name
Almut Brundert
Contact Person Email
a.brundert@kem-med.com

Greece

Latest Decision Or Authorization Date
25-09-2024
Number Of Sites
7
Number Of Participants
19

Sites

Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
University Pulmonary Department
Principal Investigator Name
Dionysios Spyratos
Principal Investigator Email
diospyrato@yahoo.gr
Contact Person Name
Dionysios Spyratos
Contact Person Email
diospyrato@yahoo.gr
Site Name
General Oncological Hospital Of Kifissia Agioi Anargyroi
Department Name
Department of Medical Oncology
Principal Investigator Name
Joseph Sgouros
Principal Investigator Email
josephsgouros@yahoo.co.uk
Contact Person Name
Joseph Sgouros
Contact Person Email
josephsgouros@yahoo.co.uk
Site Name
Athens Medical Center S.A.
Department Name
Oncology Department
Principal Investigator Name
Sofia Baka
Principal Investigator Email
bakasofia@hotmail.com
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
Henry Dunant Hospital Center
Department Name
4th Oncology Department
Principal Investigator Name
Ioannis Mountzios
Principal Investigator Email
gmountzios@gmail.com
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com
Site Name
General University Hospital Of Larissa
Department Name
Oncology Clinic-1st Internal Medicine Division
Principal Investigator Name
Athanasios Kotsakis
Principal Investigator Email
thankotsakis@hotmail.com
Contact Person Name
Athanasios Kotsakis
Contact Person Email
thankotsakis@hotmail.com
Site Name
Metropolitan Hospital
Department Name
4th Oncology Department
Principal Investigator Name
Helena Linardou
Principal Investigator Email
elinardou@metropolitan-hospital.gr
Contact Person Name
Helena Linardou
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd Internal Medicine Department of Athens University-Oncology Unit
Principal Investigator Name
Konstantinos Syrigos
Principal Investigator Email
ksyrigos.trials@gmail.com
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com

Hungary

Latest Decision Or Authorization Date
15-07-2024
Number Of Sites
1
Number Of Participants
30

Sites

Site Name
Semmelweis University
Department Name
Pulmonológiai Klinika
Principal Investigator Name
Veronika Müller
Principal Investigator Email
muller.veronika@med.semmelweis-univ.hu
Contact Person Name
Veronika Müller

Ireland

Latest Decision Or Authorization Date
11-07-2024
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
St James's Hospital
Department Name
Oncology
Principal Investigator Name
Sinead Cuffe
Principal Investigator Email
scuffe@stjames.ie
Contact Person Name
Sinead Cuffe
Contact Person Email
scuffe@stjames.ie
Site Name
University Hospital Limerick
Department Name
Oncology
Principal Investigator Name
Greg Korpanty
Principal Investigator Email
greg.korpanty2@hse.ie
Contact Person Name
Greg Korpanty
Contact Person Email
greg.korpanty2@hse.ie
Site Name
Beaumont Hospital
Department Name
Oncology
Principal Investigator Name
Jarushka Naidoo
Principal Investigator Email
jarushkanaidoo@beaumont.ie
Contact Person Name
Jarushka Naidoo
Contact Person Email
jarushkanaidoo@beaumont.ie
Site Name
Tallaght University Hospital
Department Name
Oncology
Principal Investigator Name
Fergal Kelleher
Principal Investigator Email
fergal.kelleher@tuh.ie
Contact Person Name
Fergal Kelleher
Contact Person Email
fergal.kelleher@tuh.ie

Italy

Latest Decision Or Authorization Date
22-07-2024
Number Of Sites
20
Number Of Participants
125

Sites

Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Thoraco-Pulmonary Department
Principal Investigator Name
Alessandro Morabito
Principal Investigator Email
a.morabito@istitutotumori.na.it
Contact Person Name
Alessandro Morabito
Site Name
Azienda Sanitaria Territoriale Di Pesaro E Urbino
Department Name
Onco-Hematology
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
Ospedale Vito Fazzi Lecce
Department Name
U.O. Oncologia Medica
Principal Investigator Name
Gianpiero Romano
Principal Investigator Email
gianpierodiego.romano@asl.lecce.it
Contact Person Name
Gianpiero Romano
Site Name
AORN San Giuseppe Moscati Avellino
Department Name
U.O. di Oncologia Medica
Principal Investigator Name
Cesare Gridelli
Principal Investigator Email
cgridelli@libero.it
Contact Person Name
Cesare Gridelli
Contact Person Email
cgridelli@libero.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
UO Oncologia Medica 2
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
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
Department of 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
Hospital Santa Maria Della Misericordia
Department Name
S.C. Oncologia Medica
Principal Investigator Name
Giulio Metro
Principal Investigator Email
giulio.metro@ospedale.perugia.it
Contact Person Name
Giulio Metro
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Thoracic Oncology Division
Principal Investigator Name
Filippo De Marinis
Principal Investigator Email
filippo.demarinis@ieo.it
Contact Person Name
Filippo De Marinis
Contact Person Email
filippo.demarinis@ieo.it
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
UO Oncologia Medica Per la Patologia Toracica
Principal Investigator Name
Domenico Galetta
Principal Investigator Email
galetta@oncologico.bari.it
Contact Person Name
Domenico Galetta
Contact Person Email
galetta@oncologico.bari.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
UO Oncologia Medica
Principal Investigator Name
Salvatore Grisanti
Principal Investigator Email
grisanti.salvatore@gmail.com
Contact Person Name
Salvatore Grisanti
Contact Person Email
grisanti.salvatore@gmail.com
Site Name
ARNAS Garibaldi Di Catania
Department Name
Oncologia Medica
Principal Investigator Name
Roberto Bordonaro
Principal Investigator Email
rbordonaro@arnasgaribaldi.it
Contact Person Name
Roberto Bordonaro
Contact Person Email
rbordonaro@arnasgaribaldi.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
SCDU Oncologia
Principal Investigator Name
Federica Biello
Principal Investigator Email
federica.biello@maggioreosp.novara.it
Contact Person Name
Federica Biello
Site Name
Azienda Sociosanitaria 3
Department Name
SSD Oncologia, PO Villa Scassi
Principal Investigator Name
Paola Taveggia
Principal Investigator Email
paola.taveggia@asl3.liguria.it
Contact Person Name
Paola Taveggia
Contact Person Email
paola.taveggia@asl3.liguria.it
Site Name
Careggi University Hospital
Department Name
SODc Oncologia Medica e Clinica
Principal Investigator Name
Lorenzo Antonuzzo
Principal Investigator Email
antonuzzol@aou-careggi.toscana.it
Contact Person Name
Lorenzo Antonuzzo
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
S.C. Oncologia Medica
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
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
SC Oncologia Medica 1
Principal Investigator Name
Giuseppe Lo Russo
Principal Investigator Email
giuseppe.lorusso@istitutotumori.mi.it
Contact Person Name
Giuseppe Lo Russo
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
UO Oncologia Medica
Principal Investigator Name
Marcello Tiseo
Principal Investigator Email
mtiseo@ao.pr.it
Contact Person Name
Marcello Tiseo
Contact Person Email
mtiseo@ao.pr.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
S.C. Oncologia Medica 2
Principal Investigator Name
Carlo Genova
Principal Investigator Email
carlo.genova@hsanmartino.it
Contact Person Name
Carlo Genova
Contact Person Email
carlo.genova@hsanmartino.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
UO Oncologia Medica
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 Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
Department Name
SC Oncologia
Principal Investigator Name
Silvia Zai
Principal Investigator Email
szai@ospedale.al.it
Contact Person Name
Silvia Zai
Contact Person Email
szai@ospedale.al.it

Netherlands

Latest Decision Or Authorization Date
16-07-2024
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Amphia Hospital
Department Name
Pneumology
Principal Investigator Name
Kornelius van Der Leest
Principal Investigator Email
cvanderleest@amphia.nl
Contact Person Name
Kornelius van Der Leest
Contact Person Email
cvanderleest@amphia.nl
Site Name
Radboud universitair medisch centrum / RADBOUDUMC
Department Name
Department Respiratory Diseases
Principal Investigator Name
Wouter van Geffen
Principal Investigator Email
wouter.van.geffen@mcl.nl
Contact Person Name
Wouter van Geffen
Contact Person Email
wouter.van.geffen@mcl.nl
Site Name
St. Antonius Ziekenhuis
Department Name
Pneumology
Principal Investigator Name
Lisanne Kastelijn
Principal Investigator Email
l.kastelijn1@antoniusziekenhuis.nl
Contact Person Name
Lisanne Kastelijn
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Department of Respiratory Medicine
Principal Investigator Name
Lizza Hendriks
Principal Investigator Email
lizza.hendriks@mumc.nl
Contact Person Name
Lizza Hendriks
Contact Person Email
lizza.hendriks@mumc.nl

Poland

Latest Decision Or Authorization Date
04-08-2024
Number Of Sites
6
Number Of Participants
22

Sites

Site Name
Mruk-Med I Sp. z o.o.
Principal Investigator Name
Andrzej Mruk
Principal Investigator Email
kmruk1@vp.pl
Contact Person Name
Andrzej Mruk
Contact Person Email
kmruk1@vp.pl
Site Name
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
Department Name
Pulmonary disease department
Principal Investigator Name
Aleksandra Szczęsna
Principal Investigator Email
sekretariat.otw@otwock-szpital.pl
Contact Person Name
Aleksandra Szczęsna
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Oncology
Principal Investigator Name
Dariusz Kowalski
Principal Investigator Email
biurokomunikacji@mz.gov.pl
Contact Person Name
Dariusz Kowalski
Contact Person Email
biurokomunikacji@mz.gov.pl
Site Name
Specjalistyczna Praktyka Lekarska Slawomir Mandziuk
Department Name
Oncology
Principal Investigator Name
Sławomir Mańdziuk
Principal Investigator Email
Slawman7@wp.pl
Contact Person Name
Sławomir Mańdziuk
Contact Person Email
Slawman7@wp.pl
Site Name
Ms Pneumed Janusz Milanowski Katarzyna Szmygin-Milanowska sp.j.
Principal Investigator Name
Janusz Milanowski
Principal Investigator Email
mspneumed@gmail.com
Contact Person Name
Janusz Milanowski
Contact Person Email
mspneumed@gmail.com
Site Name
Pratia S.A.
Principal Investigator Name
Marcin Grabicki
Principal Investigator Email
kontakt@pratia.com
Contact Person Name
Marcin Grabicki
Contact Person Email
kontakt@pratia.com

Portugal

Latest Decision Or Authorization Date
12-07-2024
Number Of Sites
7
Number Of Participants
28

Sites

Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Unidade de Investigação Clínica
Principal Investigator Name
Cristina Oliveira
Principal Investigator Email
croliveira@ipoporto.min-saude.pt
Contact Person Name
Cristina Oliveira
Site Name
Hospital Cuf Descobertas S.A.
Department Name
-
Principal Investigator Name
Maria Encarnacao Macedo Teixeira
Principal Investigator Email
maria.encarnacao.teixeira@jmellosaude.pt
Contact Person Name
Maria Encarnacao Macedo Teixeira
Site Name
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.
Department Name
Serviço de Oncologia Médica - Investigação
Principal Investigator Name
Sara Póvoa
Principal Investigator Email
3957@ipocoimbra.min-saude.pt
Contact Person Name
Sara Póvoa
Contact Person Email
3957@ipocoimbra.min-saude.pt
Site Name
Unidade Local De Saude Do Alto Ave E.P.E.
Department Name
Gabinete de Investigação Clínica
Principal Investigator Name
Maria Manuel Figueiredo
Contact Person Name
Maria Manuel Figueiredo
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Hospital de dia de Oncologia
Principal Investigator Name
Fernando José Santos Barata
Principal Investigator Email
fjssbarata@gmail.com
Contact Person Name
Fernando José Santos Barata
Contact Person Email
fjssbarata@gmail.com
Site Name
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Department Name
Serviço de Pneumologia
Principal Investigator Name
Telma Sequeira
Principal Investigator Email
tsequeira@ipolisboa.min-saude.pt
Contact Person Name
Telma Sequeira
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Serviço de Investigação Clínica
Principal Investigator Name
António Manuel Ferreira Araújo
Principal Investigator Email
antonio.araujo@chporto.min-saude.pt
Contact Person Name
António Manuel Ferreira Araújo

Romania

Latest Decision Or Authorization Date
15-07-2024
Number Of Sites
11
Number Of Participants
18

Sites

Site Name
Spitalul Judetean De Urgenta Dr. Constantin Opris Baia Mare
Department Name
Oncologie Medicala
Principal Investigator Name
Dumitru Filip
Principal Investigator Email
directiune@sjbm.ro
Contact Person Name
Dumitru Filip
Contact Person Email
directiune@sjbm.ro
Site Name
Oncolab S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Dan Stelian Stefan Lungulescu
Principal Investigator Email
dan.lungulescu@yahoo.com
Contact Person Name
Dan Stelian Stefan Lungulescu
Contact Person Email
dan.lungulescu@yahoo.com
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Michael Schenker
Principal Investigator Email
mike_schenker@yahoo.com
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com
Site Name
Medisprof S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Anghel-Adrian Udrea
Principal Investigator Email
adrianudrea@medisprof.ro
Contact Person Name
Anghel-Adrian Udrea
Contact Person Email
adrianudrea@medisprof.ro
Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
Oncologie Medicala
Principal Investigator Name
Aurelia Alexandru
Principal Investigator Email
auralexandru@yahoo.com
Contact Person Name
Aurelia Alexandru
Contact Person Email
auralexandru@yahoo.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncologie Medicala
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
Hyperclinica MedLife Policlinica de Diagnostic Rapid Turnului Brasov
Department Name
Oncologie
Principal Investigator Name
Daniel Ciurescu
Principal Investigator Email
ciurescu@yahoo.com
Contact Person Name
Daniel Ciurescu
Contact Person Email
ciurescu@yahoo.com
Site Name
Centrul De Oncologie-Euroclinic S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Constantin Volovat
Principal Investigator Email
cvolovat@gmail.com
Contact Person Name
Constantin Volovat
Contact Person Email
cvolovat@gmail.com
Site Name
Oncomed S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Dorel Ionel Popovici
Principal Investigator Email
valeriu.boruga@oncohelp.ro
Contact Person Name
Dorel Ionel Popovici
Contact Person Email
valeriu.boruga@oncohelp.ro
Site Name
Oncocenter Oncologie Clinica S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Roxana Scheusan
Principal Investigator Email
office@oncocenter.ro
Contact Person Name
Roxana Scheusan
Contact Person Email
office@oncocenter.ro
Site Name
Ovidius Clinical Hospital S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Laura Mazilu
Principal Investigator Email
office@ovidius-ch.ro
Contact Person Name
Laura Mazilu
Contact Person Email
office@ovidius-ch.ro

Spain

Latest Decision Or Authorization Date
11-07-2024
Number Of Sites
23
Number Of Participants
80

Sites

Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Principal Investigator Name
Vanesa Gutierrez Calderón
Principal Investigator Email
vanesa_gutierrez78@hotmail.com
Contact Person Name
Vanesa Gutierrez Calderón
Contact Person Email
vanesa_gutierrez78@hotmail.com
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncology
Principal Investigator Name
Mariano Provencio Pulla
Principal Investigator Email
mprovencio.ensayosclinicos@gmail.com
Contact Person Name
Mariano Provencio Pulla
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Medical Oncology
Principal Investigator Name
Delvys Rodríguez Abreu
Principal Investigator Email
drodabr@gobiernodecanarias.org
Contact Person Name
Delvys Rodríguez Abreu
Contact Person Email
drodabr@gobiernodecanarias.org
Site Name
Hospital Universitario De Leon
Department Name
Oncology Department
Principal Investigator Name
Soledad Medina Valdivieso
Principal Investigator Email
soledadmedina@saludcastillayleon.es
Contact Person Name
Soledad Medina Valdivieso
Site Name
University Hospital Son Espases
Department Name
Oncology
Principal Investigator Name
Aitor Azkárate Martínez
Principal Investigator Email
aitor.azkarate@ssib.es
Contact Person Name
Aitor Azkárate Martínez
Contact Person Email
aitor.azkarate@ssib.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Principal Investigator Name
Manuel Dómine Gomez
Principal Investigator Email
ensayoscancerpulmonfjd@gmail.com
Contact Person Name
Manuel Dómine Gomez
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Early Drug Development Group - Medical Oncology Department
Principal Investigator Name
Enric Carcereny Costa
Principal Investigator Email
ecarcereny@iconcologia.net
Contact Person Name
Enric Carcereny Costa
Contact Person Email
ecarcereny@iconcologia.net
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Oncology Department
Principal Investigator Name
Bartomeu Massuti Sureda
Principal Investigator Email
massuti.oncoalicante@gmail.com
Contact Person Name
Bartomeu Massuti Sureda
Contact Person Email
massuti.oncoalicante@gmail.com
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Oncology
Principal Investigator Name
Maria Dolores Isla Casado
Principal Investigator Email
lola.isla@gmail.com
Contact Person Name
Maria Dolores Isla Casado
Contact Person Email
lola.isla@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Thoracic Oncology Unit – Medical Oncology Department
Principal Investigator Name
Oscar José Juan Vidal
Principal Investigator Email
juan_osc@gva.es
Contact Person Name
Oscar José Juan Vidal
Contact Person Email
juan_osc@gva.es
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Principal Investigator Name
Laura Mezquita
Principal Investigator Email
lmezquita@clinic.cat
Contact Person Name
Laura Mezquita
Contact Person Email
lmezquita@clinic.cat
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Principal Investigator Name
Carlos Aguado de la Rosa
Principal Investigator Email
carlos.aguado84@gmail.com
Contact Person Name
Carlos Aguado de la Rosa
Contact Person Email
carlos.aguado84@gmail.com
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Internal Medicine
Principal Investigator Name
Javier Valdivia Bautista
Principal Investigator Email
jvaldib@gmail.com
Contact Person Name
Javier Valdivia Bautista
Contact Person Email
jvaldib@gmail.com
Site Name
Hospital Universitario De Cruces
Department Name
Oncology
Principal Investigator Name
Raquel Casas Cornejo
Principal Investigator Email
raquel.casascornejo@osakidetza.eus
Contact Person Name
Raquel Casas Cornejo
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology Department
Principal Investigator Name
María Pilar Garrido López
Principal Investigator Email
pilargarridol@gmail.com
Contact Person Name
María Pilar Garrido López
Contact Person Email
pilargarridol@gmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Principal Investigator Name
María Rosario
Principal Investigator Email
ma.rosario.garcia.campelo@sergas.es
Contact Person Name
María Rosario
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Oncology
Principal Investigator Name
Gonzálo Fernández Hinojal
Principal Investigator Email
gfernandezh@unav.es
Contact Person Name
Gonzálo Fernández Hinojal
Contact Person Email
gfernandezh@unav.es
Site Name
Hospital Beata Maria Ana
Department Name
Oncology
Principal Investigator Name
Araceli Priego Priego
Principal Investigator Email
araceli.priego@iob-onco.com
Contact Person Name
Araceli Priego Priego
Contact Person Email
araceli.priego@iob-onco.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology Department
Principal Investigator Name
María de los Reyes Bernabé Caro
Principal Investigator Email
bernabeensayos@gmail.com
Contact Person Name
María de los Reyes Bernabé Caro
Contact Person Email
bernabeensayos@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncology
Principal Investigator Name
Marta Lopez-Brea Piqueras
Principal Investigator Email
martafrancisca.lopezbrea@scsalud.es
Contact Person Name
Marta Lopez-Brea Piqueras
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

Sponsor

Primary sponsor

Full Name
Mirati Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Sponsor duties codes: 1, 12, 2, 5, 8, 9
Name
Pharmaceutical Product Development LLC
Responsibilities
Safety database/ SAE Processing
Name
PRA Hellas CRO A.E.
Responsibilities
Regulatory, SUSAR Reporting

Third parties

  • {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"MRTX849 pharmacokinetic testing","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Reception and storage of all pharmacokinetic + KRAS G12C samples. KRAS G12C tumor tissue testing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Resolution Bioscience Inc.","duties_or_roles":"Retrospective clinical ctDNA sample analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Storage of tumor tissue samples and ctDNA blood samples","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Sponsor duties codes: 1, 12, 2, 5, 8, 9","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Subject Travel Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"France","full_name":"Quipment","duties_or_roles":"Medical Equipment and Ancillary Supplies","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Reception and storage of all pharmacokinetic and KRAS G12C samples, KRAS G12C tumor tissue testing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Data capture / eClinical systems (responsibility code 7)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Safety database/ SAE Processing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"Role code 3","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"Regulatory, SUSAR Reporting and other duties (codes: 1, 15, 2, 9)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Adagrasib
Active Substance
ADAGRASIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
1200 mg
Investigational Product Name
Docetaxel (TAXOTERE formulations)
Active Substance
DOCETAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (TAXOTERE marketing authorisations present for multiple formulations)
Maximum Dose
75 mg/m2

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