Clinical trial • Phase III • Oncology

DIVARASIB for Non-small cell lung cancer (non-squamous), KRAS G12C-mutated, advanced or metastatic

Phase III trial of DIVARASIB for Non-small cell lung cancer (non-squamous), KRAS G12C-mutated, advanced or metastatic.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer (non-squamous), KRAS G12C-mutated, advanced or metastatic
Trial Stage
Phase III
Drug Modality
Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
30-06-2025
First CTIS Authorization Date
21-10-2025

Trial design

Randomised, open-label, pembrolizumab plus pemetrexed and carboplatin or cisplatin (comparator regimen: pembrolizumab + pemetrexed + carboplatin or cisplatin). dose and schedule not specified in provided data.-controlled Phase III trial in Hungary, Italy, Netherlands and others.

Randomised
Yes
Open Label
Yes
Comparator
Pembrolizumab plus pemetrexed and carboplatin or cisplatin (comparator regimen: pembrolizumab + pemetrexed + carboplatin or cisplatin). Dose and schedule not specified in provided data.
Biomarker Stratified
True, biomarker: KRAS G12C mutation, strata: not specified
Target Sample Size
318

Eligibility

Recruits 318 Vulnerable populations are selected (isVulnerablePopulationSelected = true). Study documentation includes subject information and consent forms specific to infants and pregnant partners (examples in the document list: "L1_Infant Authorisation", "L1_Pregnant_Partner_redacted", "L1_ICF Infant Health", and various country-specific ICFs). Specific procedures for assent or detailed handling of consent for minors/assent are not explicitly described in the available text..

Vulnerable Population
Vulnerable populations are selected (isVulnerablePopulationSelected = true). Study documentation includes subject information and consent forms specific to infants and pregnant partners (examples in the document list: "L1_Infant Authorisation", "L1_Pregnant_Partner_redacted", "L1_ICF Infant Health", and various country-specific ICFs). Specific procedures for assent or detailed handling of consent for minors/assent are not explicitly described in the available text.

Inclusion criteria

  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, with assessment scale\n- Life expectancy of at least 12 weeks\n- Measurable disease, as defined by RECIST v1.1\n- No prior systemic treatment for advanced or metastatic non−small cell lung cancer (NSCLC)\n- Documentation of the presence of a KRAS G12C mutation either through central laboratory testing of a tumor tissue sample (as per local IVD regulations), or preexisting test results of a blood or tumor tissue sample\n- Histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy"}

Exclusion criteria

  • {"criterion_text":"- Symptomatic, untreated, or actively progressing CNS metastases\n- Known concomitant second oncogenic driver with available targeted treatment\n- Prior treatment with KRAS G12C inhibitors or pan-KRAS/RAS inhibitors\n- Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the study\n- Palliative radiation to bone metastases within 2 weeks prior to randomization to ensure adequate recovery from the effects of radiotherapy\n- Significant cardiovascular disease within 3 months prior to screening"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS, defined as the time from randomization to disease progression, as determined by BICR according to RECIST v1.1, or death from any cause (whichever occurs first)","definition_or_measurement_approach":"Progression-free survival (PFS) measured from randomization to disease progression as determined by independent blinded central review (BICR) using RECIST v1.1, or death from any cause; whichever occurs first."}
  • {"endpoint_text":"- OS, defined as time from randomization to death from any cause","definition_or_measurement_approach":"Overall survival (OS) measured as time from randomization to death from any cause."}

Secondary endpoints

  • {"endpoint_text":"- Confirmed objective response, defined as CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by BICR according to RECIST v1.1","definition_or_measurement_approach":"Confirmed objective response (CR or PR) on two consecutive assessments ≥4 weeks apart, determined by BICR per RECIST v1.1."}
  • {"endpoint_text":"- Change from baseline to Cycle 5 Day 1 on the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-LC13 cough item (item 31), the QLQ-C30 dyspnea item (item 8), and the QLQ-C30 Physical Functioning scale (items 1−5)","definition_or_measurement_approach":"Patient-reported outcomes measured by EORTC QLQ-LC13 (cough item 31) and QLQ-C30 (dyspnea item 8 and Physical Functioning scale items 1-5), change from baseline to Cycle 5 Day 1."}
  • {"endpoint_text":"- DOR, defined as the time from the first occurrence of a documented objective response to disease progression, as determined by BICR according to RECIST v1.1, or death from any cause, whichever occurs first","definition_or_measurement_approach":"Duration of response (DOR) measured from first documented objective response to disease progression by BICR per RECIST v1.1, or death from any cause."}
  • {"endpoint_text":"- Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 grading scale","definition_or_measurement_approach":"Safety assessed by incidence and severity of adverse events graded by NCI CTCAE v5.0."}
  • {"endpoint_text":"- Change from baseline in selected vital signs and ECG parameters","definition_or_measurement_approach":"Clinical safety assessments of selected vital signs and ECG parameters, change from baseline."}
  • {"endpoint_text":"- Change from baseline in selected clinical laboratory test results","definition_or_measurement_approach":"Clinical laboratory tests (selected analytes), change from baseline."}
  • {"endpoint_text":"- Presence, frequency of occurrence, severity, and/or degree of interference with daily function of selected symptomatic treatment toxicities as assessed by the NCI PRO-CTCAE","definition_or_measurement_approach":"Patient-reported symptomatic toxicities assessed using NCI PRO-CTCAE: presence, frequency, severity and interference with daily functioning."}
  • {"endpoint_text":"- Worst post-baseline scores in the severity of selected symptomatic treatment toxicities as assessed by the NCI PRO-CTCAE","definition_or_measurement_approach":"Worst post-baseline severity scores for selected symptomatic toxicities on NCI PRO-CTCAE."}
  • {"endpoint_text":"- Frequency of participant’s response of the degree they are troubled with treatment symptoms, as assessed by the single-item European Organisation for Research and Treatment of Cancer (EORTC) Item List 46 (IL46)","definition_or_measurement_approach":"Participant responses to single-item EORTC IL46 assessing degree bothered by treatment symptoms; frequency of responses reported."}
  • {"endpoint_text":"- Change from baseline on the EORTC QLQ-C30 and QLQ-LC13 functional and global health status (GHS)/quality of life (QoL) scales, and symptoms to Cycle 5 Day 1 and throughout the trial","definition_or_measurement_approach":"Patient-reported outcomes measured by EORTC QLQ-C30 and QLQ-LC13 functional and global health / QoL scales and symptom scales; change from baseline to Cycle 5 Day 1 and over study duration."}

Recruitment

Digital Remote Recruitment
True, digital methods include social media posts, digital patient flyers and digital patient materials (e.g. "K2_Social Media Post v1_CO45042", digital Patient Thank You Letter), intended for patient-targeted outreach.
Planned Sample Size
318
Recruitment Window Months
63
Consent Approach
Informed consent is obtained using subject information sheets and informed consent forms (ICFs); materials include main ICF, prescreening ICF, optional biopsy ICF, pregnant partner authorisation, infant authorisation and GDPR/privacy forms. Country- and language-specific ICFs are provided (examples include English, French, Dutch, Italian, Portuguese, Spanish, Hungarian, Greek translations in protocol/ICF materials). Consent is obtained from participants; specific assent procedures for minors are not explicitly described in the available documents.

Methods

  • Patient-facing printed materials: patient flyers/leaflets (country-specific flyers available: English, French, Dutch, Italian, and other translations as per document list), patient cards and study leaflets targeted to potential participants.
  • Healthcare professional (HCP) referral letters and HCP-targeted materials to facilitate clinician referrals (documents titled HCP referral exist in multiple country packages).
  • Digital recruitment: social media posts (document: "K2_Social Media Post v1_CO45042"), digital patient flyers and digital patient thank you/engagement materials.
  • Local country recruitment arrangements and study leaflets (K1 recruitment arrangements documents available for multiple countries describing local procedures and channels).
  • Site-based recruitment via participating hospitals/oncology clinics (site lists provided for each country).

Geography

Total Number Of Sites
125
Total Number Of Participants
282

Hungary

Earliest CTIS Part Ii Submission Date
22-09-2025
Latest Decision Or Authorization Date
27-10-2025
Processing Time Days
35
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Matrai Gyogyintezet
Contact Person Name
Istvan Albert
Contact Person Email
albert.magy@gmail.com
Site Name
Orszagos Koranyi Pulmonologiai Intezet
Department Name
XIV. Pulmonologiai Osztaly
Contact Person Name
Gabriella Temesi
Contact Person Email
temesi@koranyi.hu
Site Name
University Of Pecs
Department Name
Onkoterapias Klinika
Contact Person Name
Arpad Boronkai
Contact Person Email
arpad.boronkai@gmail.com
Site Name
Reformatus Pulmonologiai Centrum
Department Name
Onkologiai Ambulancia
Contact Person Name
Gabriella Galffy
Site Name
Semmelweis University
Department Name
Pulmonologiai Klinika
Contact Person Name
Veronika Muller
Contact Person Email
muller.veronika@semmelweis.hu

Italy

Earliest CTIS Part Ii Submission Date
15-09-2025
Latest Decision Or Authorization Date
22-10-2025
Processing Time Days
37
Number Of Sites
14
Number Of Participants
40

Sites

Site Name
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Department Name
Oncologia
Contact Person Name
Giacomo Allegrini
Site Name
Azienda Sanitaria Territoriale Di Pesaro E Urbino
Department Name
Oncologia
Contact Person Name
Rita Chiari
Contact Person Email
rita.chiari@sanitamarche.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Oncologia
Contact Person Name
Emilio Bria
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Oncologia Medica
Contact Person Name
Diego Cortinovis
Site Name
Humanitas Istituto Clinico Catanese S.p.A.
Department Name
Oncologia e Ematologia
Contact Person Name
Alessandro Russo
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Toracico-Polmonare
Contact Person Name
Alessandro Morabito
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Oncologia Toracica
Contact Person Name
Antonio Passaro
Contact Person Email
antonio.passaro@ieo.it
Site Name
San Camillo Forlanini Hospital
Department Name
Oncologia
Contact Person Name
Serena Ricciardi
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Oncologia
Contact Person Name
Diego Signorelli
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Oncologia
Contact Person Name
Federica Bertolini
Contact Person Email
bertolini.federica@aou.mo.it
Site Name
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.
Department Name
Oncologia Toracica
Contact Person Name
Antonio Santo
Contact Person Email
urp@ospedalepederzoli.it
Site Name
Azienda Sanitaria Locale Di Taranto
Department Name
Oncologia
Contact Person Name
Salvatore Pisconti
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Oncologia
Contact Person Name
Brigida Stanzione
Contact Person Email
brigida.stanzione@cro.it
Site Name
Azienda Ospedaliera Dei Colli
Department Name
Pneumologia Oncologica
Contact Person Name
Fabiana Vitiello

Netherlands

Earliest CTIS Part Ii Submission Date
25-09-2025
Latest Decision Or Authorization Date
21-10-2025
Processing Time Days
26
Number Of Sites
8
Number Of Participants
10

Sites

Site Name
Amphia Hospital
Department Name
Lung Diseases
Contact Person Name
Lysanne Lievense
Contact Person Email
slievense@amphia.nl
Site Name
Rijnstate Ziekenhuis Stichting
Department Name
Lung Diseases
Contact Person Name
Anne Bressers
Contact Person Email
abressers@rijnstate.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Lung Diseases
Contact Person Name
Willemijn Theelen
Contact Person Email
w.theelen@nki.nl
Site Name
Isala Klinieken Stichting
Department Name
Lung Diseases
Contact Person Name
Peter Plomp
Contact Person Email
p.m.j.plomp@isala.nl
Site Name
Meander Medisch Centrum
Department Name
Lung
Contact Person Name
Judith Herder
Contact Person Email
Longtrial@meandermc.nl
Site Name
Haaglanden Medisch Centrum Stichting
Department Name
Lung
Contact Person Name
Sevim Uzun
Contact Person Email
s.uzun@haaglandenmc.nl
Site Name
Ziekenhuis St Jansdal
Department Name
Lung Diseases
Contact Person Name
Lisenka Boom
Contact Person Email
LN.Boom@stjansdal.nl
Site Name
Meander Medisch Centrum (duplicate listed as site)
Department Name
Lung
Contact Person Name
Judith Herder
Contact Person Email
Longtrial@meandermc.nl

Spain

Earliest CTIS Part Ii Submission Date
14-07-2025
Latest Decision Or Authorization Date
24-10-2025
Processing Time Days
102
Number Of Sites
15
Number Of Participants
35

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Noemi Reguart
Contact Person Email
nreguart@clinic.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Enriqueta Felip
Contact Person Email
efelip@vhio.net
Site Name
University Hospital Son Espases
Department Name
Oncology
Contact Person Name
Aitor Azkarate
Contact Person Email
aitor.azkarate@ssib.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Contact Person Name
Pilar Garrido
Contact Person Email
pgarrido@salud.madrid.org
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Oncology
Contact Person Name
Jose Carlos Benitez
Contact Person Email
josecarlos.benitez@ibima.eu
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology
Contact Person Name
Margarita Majem
Contact Person Email
mmajem@santpau.cat
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncology
Contact Person Name
Marta Lopez-Brea
Contact Person Email
marta.lopezbrea@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Luis Paz-Ares
Contact Person Email
lpazaresr@seom.org
Site Name
Hospital Universitario La Paz
Department Name
Oncology
Contact Person Name
Javier De Castro
Contact Person Email
javierdecastro5@gmail.com
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Oncology
Contact Person Name
Delvys Rodriguez
Contact Person Email
delvysra@yahoo.com
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Oncology
Contact Person Name
Miguel Fernandez de Sanmamed
Contact Person Email
msanmamed@unav.es
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Oncology
Contact Person Name
Miguel Fernández de Sanmamed
Contact Person Email
msanmamed@unav.es
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Ernest Nadal
Contact Person Email
esnadal@iconcologia.net
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Contact Person Name
Amelia Insa
Contact Person Email
ameliainsamolla@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Contact Person Name
David Vicente Baz
Contact Person Email
david.vbaz@gmail.com

Greece

Earliest CTIS Part Ii Submission Date
14-07-2025
Latest Decision Or Authorization Date
21-10-2025
Processing Time Days
99
Number Of Sites
7
Number Of Participants
18

Sites

Site Name
Henry Dunant Hospital Center
Department Name
4th Oncology Department
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com
Site Name
Alexandra Hospital
Department Name
Medical Oncology Unit Department of Clinical Therapeutics
Contact Person Name
Michalis Liontos
Contact Person Email
mliontos@gmail.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd Department of Internal Medicine/Oncology Unit
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com
Site Name
Theageneio Cancer Hospital
Department Name
Β Chemotherapy Oncology Department
Contact Person Name
Grigorios Rallis
Contact Person Email
grrallis@yahoo.com
Site Name
St. Luke's Hospital S.A.
Department Name
Department of Medical Oncology
Contact Person Name
Eleni Fountzila
Contact Person Email
elenafou@gmail.com
Site Name
General University Hospital Of Larissa
Department Name
Oncology Clinic
Contact Person Name
Athanasios Kotsakis
Contact Person Email
thankotsakis@hotmail.com
Site Name
Athens Medical Center S.A.
Department Name
Oncology Department
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com

Poland

Earliest CTIS Part Ii Submission Date
22-09-2025
Latest Decision Or Authorization Date
29-10-2025
Processing Time Days
37
Number Of Sites
12
Number Of Participants
32

Sites

Site Name
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Centrum Innowacyjnych Terapii
Contact Person Name
Izabela Chmielewska
Contact Person Email
cwbk@umlub.pl
Site Name
Radomskie Centrum Onkologii
Department Name
Kliniczny Oddział Chemioterapii
Contact Person Name
Tadeusz Pieńkowski
Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oddział Onkologii z Pododdziałem Chemioterapii
Contact Person Name
Jarosław Kołb-Sielecki
Site Name
Centrum Pulmonologii I Torakochirurgii W Bystrej
Department Name
Oddział Pulmonologiczno-Onkologiczny z Chemioterapią
Contact Person Name
Brygida Kinga Brudny-Borowska
Contact Person Email
bborowska@szpitalbystra.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Rafał Dziadziuszko
Contact Person Email
rafald@gumed.edu.pl
Site Name
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Department Name
Oddział Onkologii z Pododdziałem Diagnostyki Nowotworów Klatki Piersiowej
Contact Person Name
Grzegorz Czyżewicz
Site Name
Centrum Pulmonologii i Torakochirurgii (National Institute Of Tuberculosis And Lung Diseases)
Department Name
III Klinika Chorób Płuc i Onkologii
Contact Person Name
Mateusz Polaczek
Contact Person Email
bk3@igichp.edu.pl
Site Name
Mazowiecki Szpital Onkologiczny Sp. z o.o.
Department Name
Poradnia Onkologiczna
Contact Person Name
Sylwina Socha
Site Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Dziennej Chemioterapii
Contact Person Name
Katarzyna Stencel
Contact Person Email
kstencel@wcpit.pl
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Oddział Onkologii Klinicznej (Nowotworów Klatki Piersiowej)
Contact Person Name
Krzysztof Rogoziewicz
Contact Person Email
onkocwbk@dcopih.pl
Site Name
Warminsko-Mazurskie (additional site listing)
Site Name
Additional Polish participating site

Portugal

Earliest CTIS Part Ii Submission Date
25-09-2025
Latest Decision Or Authorization Date
23-10-2025
Processing Time Days
28
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Serviço de Oncologia
Contact Person Name
Ana Daniela Marques
Contact Person Email
2ca@ccabraga.org
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Serviço de Oncologia Médica
Contact Person Name
Marta Soares
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Serviço de Pneumologia
Contact Person Name
Margarida Pinho Dias
Site Name
Unidade Local De Saude De Loures-Odivelas EPE
Department Name
Centro de Investigação e Inovação
Contact Person Name
João Moreira Pinto

Germany

Earliest CTIS Part Ii Submission Date
30-09-2025
Latest Decision Or Authorization Date
22-10-2025
Processing Time Days
22
Number Of Sites
26
Number Of Participants
59

Sites

Site Name
Universitaetsklinikum Essen AöR
Department Name
Innere Klinik (Tumorforschung)
Contact Person Name
Martin Schuler
Contact Person Email
martin.schuler@uk-essen.de
Site Name
Universitaet Muenster
Department Name
Gebäude 1A Ebene 15A West Studienbüro
Contact Person Name
Georg Evers
Contact Person Email
georg.evers@ukmuenster.de
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Lungenzentrum Hamburg - Pneumologie
Contact Person Name
Claas Wesseler
Contact Person Email
c.wesseler@asklepios.com
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Gebäude 1
Contact Person Name
Farastuk Bozorgmehr
Site Name
Klinikum Esslingen GmbH
Department Name
Innere Medizin, Pneumologie
Contact Person Name
Martin Faehling
Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
Abt. personalisierte Onkologie, Schwerpunkt Lungenkarzinom
Contact Person Name
Maike Collienne
Contact Person Email
maike.collienne@umm.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Innere Medizin III - Kardiologie, Pneumologie, intern. Intensivmedizin
Contact Person Name
Christian Schulz
Contact Person Email
christian.schulz@ukr.de
Site Name
Pius-Hospital Oldenburg
Department Name
Klinik f. Hämatolgie und Onkologie
Contact Person Name
Frank Griesinger
Contact Person Email
onkologie@pius-hospital.de
Site Name
HELIOS Klinikum Emil von Behring GmbH
Department Name
Klinik für Pneumologie - Lungenklinik Heckeshorn
Contact Person Name
Jens Kollmeier
Site Name
Asklepios Klinik Gauting GmbH
Department Name
Lungenklinik
Contact Person Name
Niels Reinmuth
Contact Person Email
gauting@asklepios.com
Site Name
Muenchen Klinik gGmbH
Department Name
Klinikum Bogenhausen, Klinik f. Pneumologie u. Onkologie
Contact Person Name
Konrad Kokowski
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Klinik f. Innere Medizin - Hämatologie, Onkologie u. Palliativmedizin
Contact Person Name
Peter Thuss-Patience
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Studienzentrum Pneumologie, Med. Klinik III
Contact Person Name
Sabine Bohnet
Contact Person Email
sabine.bohnet@uksh.de
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Evang. Huyssens-Stiftung Essen-Huttrop
Contact Person Name
Sebastian Ertl
Contact Person Email
s.ertl@kem-med.com
Site Name
Klinikum Region Hannover GmbH
Department Name
Klinik f. Pneumologie, Intesiv- u. Schlafmedizing
Contact Person Name
Thomas Fühner
Contact Person Email
thomas.fuehner@krh.eu
Site Name
Vincentius-Diakonissen-Kliniken gAG
Department Name
Med. Klinik 2, Klinik f. Hämatologie, Onkologie, Immunologie u. Intensivmedizin
Contact Person Name
Christian Meyer zum Büschenfelde
Contact Person Email
onkologie@vincentius-ka.de
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
Fachklinik Löwenstein
Contact Person Name
Jonas Kuon
Contact Person Email
onkologie.kloe@slk-kliniken.de
Site Name
Universitaetsklinikum des Saarlandes AöR
Department Name
Klinik f. Innere Medizin V - Pneumologie, Allergologie, Beatmungs- u. Umweltmedizin
Contact Person Name
Jan Stratmann
Contact Person Email
jan.stratmann@uks.eu
Site Name
ST. ELISABETH-KRANKENHAUS LEIPZIG gGmbH
Department Name
Innere Medizin I
Contact Person Name
Sylvia Gütz
Contact Person Email
sylvia.guetz@ek-leipzig.de
Site Name
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Department Name
Innere Medizin II - Pneumologie
Contact Person Name
Wolfgang Schütte
Site Name
Klinikum Wuerzburg Mitte gGmbH
Department Name
Schwerpunkt Pneumologie u. Beatmungsmedizin
Contact Person Name
Jens Kern
Contact Person Email
jens.kern@kwm-klinikum.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Med. Klinik Infektionologie u. Pneumologie - Campus Virchow Klinikum
Contact Person Name
Nikolaj Frost
Contact Person Email
nikolaj.frost@charite.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden
Department Name
Med. Klinik und Poliklinik I
Contact Person Name
Felix Saalfeld
Contact Person Email
Felix.saalfeld@ukdd.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Innere Medizin VIII - Med. Onkol. und Pneumologie
Contact Person Name
Thorben Groß

Belgium

Earliest CTIS Part Ii Submission Date
19-09-2025
Latest Decision Or Authorization Date
21-10-2025
Processing Time Days
32
Number Of Sites
9
Number Of Participants
16

Sites

Site Name
Algemeen Ziekenhuis Delta
Department Name
Department of respiratory diseases
Contact Person Name
Ingel Demedts
Contact Person Email
ingel.demedts@azdelta.be
Site Name
Azorg
Department Name
Pneumology
Contact Person Name
Kurt Tournoy
Contact Person Email
kurt.tournoy@azorg.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Medical oncology
Contact Person Name
Iuliana Angelica Tiotiu-Cepuc
Site Name
UZ Leuven
Department Name
Respiratory Oncology
Contact Person Name
Christophe Dooms
Contact Person Email
datanursingreo@uzleuven.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Medical oncology
Contact Person Name
Marie Lecocq
Contact Person Email
mlecocq@chuliege.be
Site Name
CHU Helora
Department Name
Oncology
Contact Person Name
Stéphane Holbrechts
Contact Person Email
stephane.holbrechts@helora.be
Site Name
UZ Brussel
Department Name
Oncology
Contact Person Name
Lore Decoster
Contact Person Email
lore.decoster@uzbrussel.be
Site Name
Jessa Ziekenhuis
Department Name
Oncology
Contact Person Name
Kristof Cuppens
Contact Person Email
kristof.cuppens@jessazh.be
Site Name
Centre hospitalier universitaire de Liege (additional listing)

Denmark

Earliest CTIS Part Ii Submission Date
24-09-2025
Latest Decision Or Authorization Date
21-10-2025
Processing Time Days
27
Number Of Sites
7
Number Of Participants
10

Sites

Site Name
Rigshospitalet
Department Name
Onkologisk afdeling
Contact Person Name
Edyta Maria Urbanska
Site Name
Herlev og Gentofte Hospital
Department Name
Onkologisk afdeling
Contact Person Name
Jon (Jon Alexander Lykkegaard Andersen)
Contact Person Email
joalan01@regionh.dk
Site Name
Region Syddanmark
Department Name
Onkologisk afdeling
Contact Person Name
Daniela Zitnjak
Contact Person Email
daniela.zitnjak@rsyd.dk
Site Name
Aarhus Universitetshospital
Department Name
Onkologisk afdeling
Contact Person Name
Eva Boysen Fynboe Ebert
Contact Person Email
evhase@rm.dk
Site Name
Regionshospitalet Goedstrup
Department Name
Onkologisk afdeling
Contact Person Name
Trine Oellegaard
Contact Person Email
trinejen@rm.dk
Site Name
Zealand University Hospital
Department Name
Onkologisk afdeling
Contact Person Name
Malene Stoechkel Frank
Contact Person Email
malf@regionsjaelland.dk
Site Name
Herlev og Gentofte Hospital (duplicate listing)

Ireland

Earliest CTIS Part Ii Submission Date
17-09-2025
Latest Decision Or Authorization Date
24-10-2025
Processing Time Days
37
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Beaumont Hospital
Department Name
Cancer Clinical Trials & Research Unit
Contact Person Name
Jarushka Naidoo
Contact Person Email
oncsec@beaumont.ie
Site Name
Tallaght University Hospital
Department Name
Oncology/Haematology Clinical Trials
Contact Person Name
Sebastian Trainor
Contact Person Email
CancerTrials@tuh.ie
Site Name
St James's Hospital
Department Name
Cancer Clinical Trials Office
Contact Person Name
Patrick Forde
Contact Person Email
research@stjames.ie
Site Name
Mater Misericordiae University Hospital
Department Name
Clinical Trials Research Unit
Contact Person Name
Deirdre Kelly
Contact Person Email
CTRU@mater.ie

France

Earliest CTIS Part Ii Submission Date
17-09-2025
Latest Decision Or Authorization Date
21-10-2025
Processing Time Days
34
Number Of Sites
14
Number Of Participants
34

Sites

Site Name
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Department Name
Pneumology
Contact Person Name
Carole Helissey
Contact Person Email
carole.helissey@gmail.com
Site Name
Centre Hospitalier De Saint-Quentin
Department Name
Pneumology
Contact Person Name
Charles Dayen
Contact Person Email
C.DAYEN@ch-stquentin.fr
Site Name
Centre Leon Berard
Department Name
Pneumology
Contact Person Name
Aurélie Swalduz
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Pneumology
Contact Person Name
Benoit Roch
Contact Person Email
b-roch@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Pneumology
Contact Person Name
Maxime Dewolf
Contact Person Email
mdewolf@chu-reims.fr
Site Name
Assistance Publique Hopitaux De Paris (Paris)
Department Name
ONCOLOGY
Contact Person Name
Jacques Cadranel
Contact Person Email
jacques.cadranel@aphp.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Medical Oncology
Contact Person Name
Céline Mascaux
Site Name
Centre Antoine Lacassagne
Department Name
Medical Oncology
Contact Person Name
Victoria Ferrari
Site Name
Centre Francois Baclesse
Department Name
Pneumology
Contact Person Name
Hubert Curcio
Contact Person Email
h.curcio@baclesse.fr
Site Name
Assistance Publique Hopitaux De Paris (Bobigny)
Department Name
ONCOLOGY
Contact Person Name
Boris Duchemann
Contact Person Email
boris.duchemann@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Medical Oncology
Contact Person Name
Remi Veillon
Contact Person Email
remi.veillon@chu-bordeaux.fr
Site Name
Centre Hospitalier Regional D'Angers
Department Name
Pneumology
Contact Person Name
Gregoire Justeau
Contact Person Email
gregoire.justeau@chu-angers.fr
Site Name
Hospices Civils De Lyon
Department Name
Pneumology
Contact Person Name
Michael Duruisseaux
Site Name
Centre Hospitalier Bretagne Atlantique
Department Name
Pneumology
Contact Person Name
Gonzague De Chabot

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Third parties

  • {"country":"France","full_name":"Median Technologies","duties_or_roles":"Central Imaging Provider","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Group Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q2q Communications Limited","duties_or_roles":"Training portal Provider","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
RO7435846
Active Substance
DIVARASIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Not authorised
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
Marketing authorisation (approved product used in trial)
Combination Treatment
Yes

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