Clinical trial • Phase II | Phase III • Respiratory
PEMBROLIZUMAB for Non-small cell lung cancer | Advanced non-small cell lung cancer
Phase II | Phase III trial of PEMBROLIZUMAB for Non-small cell lung cancer | Advanced non-small cell lung cancer.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Non-small cell lung cancer | Advanced non-small cell lung cancer
- Trial Stage
- Phase II | Phase III
- Drug Modality
- Small molecule | Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 28-08-2024
- First CTIS Authorization Date
- 03-10-2024
Trial design
Randomised, open-label, pembrolizumab 200mg iv q3w (up to 35 cycles)-controlled Phase II | Phase III trial in Belgium, Portugal, Spain and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Pembrolizumab 200mg IV Q3W (up to 35 cycles)
- Biomarker Stratified
- True: KRAS G12C mutation (eligibility) and PD-L1 Tumor Proportion Score (TPS) strata (e.g. PD-L1 ≥ 50% for Phase 3; TPS <1% and ≥1% cohorts in Phase 2)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 419
- Trial Duration For Participant
- 730
Eligibility
Recruits 419 No vulnerable population selected (isVulnerablePopulationSelected: false)..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected: false).
Inclusion criteria
- {"criterion_text":"- Phase 2: Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous) with KRAS G12C mutation and known PD-L1 TPS score and presence of measurable disease per RECIST v1.1.\n- Phase 3: Histologically or cytologically confirmed diagnosis of unresectable or metastatic NSCLC (squamous or nonsquamous) with KRAS G12C mutation and PD-L1 ≥ 50% confirmed using Sponsor-approved testing (refer to laboratory manual for current list of Sponsor-approved tests).\n- Phase 2 and 3: Presence of evaluable or measurable disease per RECIST version 1.1.\n- Phase 3: CNS Inclusion–- Based on screening brain imaging, patients must have one of the following: 1. No evidence of brain metastases 2. Untreated asymptomatic brain metastases < 2.0 cm not needing immediate local therapy 3. Previously treated brain metastases not needing immediate local therapy .\n- Phase 2 and Phase 3: Not a candidate for definitive therapy (eg, chemoradiation for locally advanced disease).\n- Phase 3: A representative tumor specimen (primary or metastatic and newly obtained or archival sample must be available to be submitted to the Sponsor during screening or within 30 days of randomization."}
Exclusion criteria
- {"criterion_text":"- Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune CIT, or a therapy targeting KRAS G12C mutation (e.g., sotorasib)\n- Phase 2 and Phase 3: Radiation to the lung > 30 Gy within 6 months prior to the first dose of study treatment.\n- Phase 2: Active brain metastases\n- Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following: 1. Any untreated or symptomatic brain lesions > 2.0 cm in size 2. Any brainstem lesions 3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of > 10 mg of prednisone (or equivalent) prior to randomization. 4. Have poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Phase 2: Obejective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by Investigator","definition_or_measurement_approach":"Objective Response Rate per RECIST v1.1 assessed by Investigator"}
- {"endpoint_text":"- Phase 3: Dual primary endpoints: 1. PFS (RECIST 1.1) by BICR 2. OS","definition_or_measurement_approach":"1. Progression-Free Survival assessed per RECIST v1.1 by Blinded Independent Central Review (BICR); 2. Overall Survival (OS) as reported in the study"}
Secondary endpoints
- {"endpoint_text":"- Phase 2: 1. Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities","definition_or_measurement_approach":"Safety assessed by recording adverse events and laboratory abnormalities (type, incidence, severity, timing, seriousness, relationship to study treatment)"}
- {"endpoint_text":"- Phase 2: 2. Duration of Response (DOR), Progression - Free Survival (PFS), 1-Year Survival rate, Overall Survival (OS)","definition_or_measurement_approach":"DOR, PFS (per RECIST v1.1), 1-year survival rate, and OS as measured in study follow-up"}
- {"endpoint_text":"- Phase 2: 3. Pharmacokinetics (PK) Blood plasma adagrasib and potential metabolite concentrations","definition_or_measurement_approach":"Measurement of adagrasib and metabolite concentrations in blood plasma (PK analyses)"}
- {"endpoint_text":"- Phase 3: 1. PFS (RECIST v1.1) by Investigator - OR (RECIST v1.1) by Investigator and BICR - DOR (RECIST v1.1) by Investigator and BICR1","definition_or_measurement_approach":"PFS, Objective Response (ORR) and Duration of Response (DOR) assessed per RECIST v1.1 by Investigator and by BICR where indicated"}
- {"endpoint_text":"- Phase 3: 2. Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, laboratory abnormalities, and number of patients discontinuing study treatment due to an AE","definition_or_measurement_approach":"Safety assessment via AE reporting, lab abnormalities and count of patients discontinuing due to AEs"}
- {"endpoint_text":"- Phase 3: 3. Population PK parameters of adagrasib","definition_or_measurement_approach":"Population pharmacokinetic parameter estimation for adagrasib"}
- {"endpoint_text":"- Phase 3: 4. Patient-reported outcome (PRO) to measure quality of life","definition_or_measurement_approach":"Patient-reported outcome instruments to assess health-related quality of life (HRQOL/PRO)"}
Recruitment
- Digital Remote Recruitment
- True: Digital/remote methods referenced in recruitment materials include Scout digital recruitment materials (Scout study brochure, ScoutPass reloadable materials), web ads (e.g. Finland Web Ad), email communications for Scout and other digital outreach; these materials are provided in country-specific packs where present.
- Planned Sample Size
- 419
- Recruitment Window Months
- 79
- Consent Approach
- Informed consent is obtained from each participant prior to study procedures. Subject information and informed consent forms (SIS-ICF and related addenda) are provided in country- and language-specific versions (documents listed for Dutch, French, Portuguese, German, Greek, Italian, Spanish, Polish, Hungarian, Czech, Bulgarian, Romanian, Norwegian, Croatian, Finnish and others). Documents include main ICFs, pre-screening ICFs, continuation forms, pregnancy and pregnant-partner information, optional sample collection consents and study-specific addenda; contact details for sponsor representative are provided in public contact documents.
Methods
- Belgium: PI-to-Patient letters, recruitment posters, patient brochures and HCP referral materials available in Dutch and French (documents K1_BE, K2_BE items). Target: patients with NSCLC and referring healthcare professionals.
- Portugal: PI-to-Patient letters, recruitment posters, patient brochures, HCP referral cards and HCP brochures in Portuguese (K1_PT, K2_PT documents). Target: patients and HCPs.
- Spain: Recruitment procedure and multiple patient-facing materials including posters, brochures and investigator/scout materials in Spanish (K1_ES, K2_ES files).
- Germany: Recruitment and informed consent procedure and patient brochures, posters and HCP flyers in German (K1_DE, K2_DE documents).
- Netherlands, Italy, France, Hungary, Poland, Romania, Austria, Bulgaria, Czechia, Greece, Denmark, Ireland, Croatia, Finland and others: country-specific recruitment packages (recruitment procedures K1_XX and recruitment materials K2_XX) including PI-to-patient letters, recruitment posters, patient brochures and HCP referral materials in local languages as listed in the CTIS documents.
- Digital recruitment: country files include Scout materials, web ads and ScoutPass-related materials (e.g. Scout Study Brochure, Reloadable ScoutPass) used for digital outreach and pre-screening in some countries (Netherlands, Ireland, Greece, Finland and others).
Geography
- Total Number Of Sites
- 174
- Total Number Of Participants
- 419
Belgium
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 16-10-2024
- Processing Time Days
- 26
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Az Maria Middelares Gent
- Department Name
- Pulmonology
- Principal Investigator Name
- Paul Germonpré
- Principal Investigator Email
- paul.germonpre@mijnziekenhuis.be
- Contact Person Name
- Paul Germonpré
- Contact Person Email
- paul.germonpre@mijnziekenhuis.be
- Site Name
- Antwerp University Hospital
- Department Name
- Pulmonary medicine-Thoracic
- 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
- Pulmunology-Thoracic Oncology
- Principal Investigator Name
- Kristof Cuppens
- Principal Investigator Email
- kristof.cuppens@jessazh.be
- Contact Person Name
- Kristof Cuppens
- Contact Person Email
- kristof.cuppens@jessazh.be
Portugal
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 03-10-2024
- Processing Time Days
- 13
- Number Of Sites
- 8
- Number Of Participants
- 16
Sites
- Site Name
- Hospital Cuf Tejo S.A.
- Department Name
- Oncology
- Principal Investigator Name
- Li Bei
- Principal Investigator Email
- li.bei@cuf.pt
- Contact Person Name
- Li Bei
- Contact Person Email
- li.bei@cuf.pt
- Site Name
- Unidade Local De Saude De Santo Antonio E.P.E.
- Department Name
- Medical Oncology service
- Principal Investigator Name
- Antonio Manuel Ferreira Araujo
- Principal Investigator Email
- antonio.araujo@chporto.min-saude.pt
- Contact Person Name
- Antonio Manuel Ferreira Araujo
- Contact Person Email
- antonio.araujo@chporto.min-saude.pt
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- Pulmonology
- Principal Investigator Name
- Ana Maria Figueiredo
- Principal Investigator Email
- amrfigueiredo@gmail.com
- Contact Person Name
- Ana Maria Figueiredo
- Contact Person Email
- amrfigueiredo@gmail.com
- Site Name
- Unidade Local De Saude Do Alto Ave E.P.E.
- Department Name
- Pulmonology
- Principal Investigator Name
- Pedro Brito
- Principal Investigator Email
- pedroulisses@hospitaldeguimaraes.min-saude.pt
- Contact Person Name
- Pedro Brito
- Contact Person Email
- pedroulisses@hospitaldeguimaraes.min-saude.pt
- Site Name
- Hospital CUF Porto S.A.
- Department Name
- Oncology
- Principal Investigator Name
- Venceslau Hespanhol
- Principal Investigator Email
- venceslau.hespanhol@cuf.pt
- Contact Person Name
- Venceslau Hespanhol
- Contact Person Email
- venceslau.hespanhol@cuf.pt
- Site Name
- Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
- Department Name
- Pulmonology
- Principal Investigator Name
- Telma Sequeira
- Principal Investigator Email
- tsequeira@ipolisboa.min-saude.pt
- Contact Person Name
- Telma Sequeira
- Contact Person Email
- tsequeira@ipolisboa.min-saude.pt
- Site Name
- Hospital Cuf Descobertas S.A.
- Department Name
- Oncology
- Principal Investigator Name
- Li Bei
- Principal Investigator Email
- li.bei@cuf.pt
- Contact Person Name
- Li Bei
- Contact Person Email
- li.bei@cuf.pt
- Site Name
- Hospital CUF Porto S.A. (duplicate entry in file structure if present)
- Department Name
- Oncology
- Principal Investigator Name
- Venceslau Hespanhol
- Principal Investigator Email
- venceslau.hespanhol@cuf.pt
- Contact Person Name
- Venceslau Hespanhol
- Contact Person Email
- venceslau.hespanhol@cuf.pt
Spain
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 16-10-2024
- Processing Time Days
- 26
- Number Of Sites
- 19
- Number Of Participants
- 65
Sites
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Oncology
- Principal Investigator Name
- Carlos Aguado
- Principal Investigator Email
- carlos.guado84@gmail.com
- Contact Person Name
- Carlos Aguado
- Contact Person Email
- carlos.guado84@gmail.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncology
- Principal Investigator Name
- Gonzalo Fernández Hinojal
- Principal Investigator Email
- gfernandezh@unav.es
- Contact Person Name
- Gonzalo Fernández Hinojal
- Contact Person Email
- gfernandezh@unav.es
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncology
- Principal Investigator Name
- Maria Amelia Insa Molla
- Principal Investigator Email
- ameliainsamolla@gmail.com
- Contact Person Name
- Maria Amelia Insa Molla
- Contact Person Email
- ameliainsamolla@gmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncology
- Principal Investigator Name
- Oscar Jose Juan Vidal
- Principal Investigator Email
- juan.osc@gva.es
- Contact Person Name
- Oscar Jose Juan Vidal
- Contact Person Email
- juan.osc@gva.es
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Oncology
- Principal Investigator Name
- Maria Rosario Garcia Campelo
- Principal Investigator Email
- ma.rosario.garcia.campelo@sergas.es
- Contact Person Name
- Maria Rosario Garcia Campelo
- Contact Person Email
- ma.rosario.garcia.campelo@sergas.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncology
- Principal Investigator Name
- Margarita Majem Tarruella
- Principal Investigator Email
- mmajem@santpau.cat
- Contact Person Name
- Margarita Majem Tarruella
- Contact Person Email
- mmajem@santpau.cat
- Site Name
- Complejo Hospitalario Universitario Insular Materno Infantil
- Department Name
- Oncology
- Principal Investigator Name
- Delvys Rodriguez Abreu
- Principal Investigator Email
- drodabr@gobiernodecanarias.org
- Contact Person Name
- Delvys Rodriguez Abreu
- Contact Person Email
- drodabr@gobiernodecanarias.org
- Site Name
- Universidade De Santiago De Compostela
- Department Name
- Oncology
- Principal Investigator Name
- Jorge Garcia Gonzalez
- Principal Investigator Email
- jorge.jose.garcia.gonzales@sergas.es
- Contact Person Name
- Jorge Garcia Gonzalez
- Contact Person Email
- jorge.jose.garcia.gonzales@sergas.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Principal Investigator Name
- Maria De Los Reyes Bernabe Caro
- Principal Investigator Email
- bernabeensayos@gmail.com
- Contact Person Name
- Maria De Los Reyes Bernabe Caro
- Contact Person Email
- bernabeensayos@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Principal Investigator Name
- Maria Pilar Garrido Lopez
- Principal Investigator Email
- pgarrido.hrc@salud.madrid.org
- Contact Person Name
- Maria Pilar Garrido Lopez
- Contact Person Email
- pgarrido.hrc@salud.madrid.org
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Oncology
- Principal Investigator Name
- Vanesa Gutiérrez Calderón
- Principal Investigator Email
- vanesa_gutierrez78@hotmail.com
- Contact Person Name
- Vanesa Gutiérrez Calderón
- Contact Person Email
- vanesa_gutierrez78@hotmail.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Manuel Dómine Gomez
- Principal Investigator Email
- mdomine@fjd.es
- Contact Person Name
- Manuel Dómine Gomez
- Contact Person Email
- mdomine@fjd.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Ernesto Nadal Alforja
- Principal Investigator Email
- esnadal@iconcologia.net
- Contact Person Name
- Ernesto Nadal Alforja
- Contact Person Email
- esnadal@iconcologia.net
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Enriqueta Felip Font
- Principal Investigator Email
- efelip@vhio.net
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- efelip@vhio.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Principal Investigator Name
- Laura Mezquita Perez
- Principal Investigator Email
- lmezquita@clinic.cat
- Contact Person Name
- Laura Mezquita Perez
- Contact Person Email
- lmezquita@clinic.cat
- Site Name
- Clinica Universidad De Navarra (other site entry)
- Department Name
- Oncology
- Principal Investigator Name
- Gonzalo Fernández Hinojal
- Principal Investigator Email
- gfernandezh@unav.es
- Contact Person Name
- Gonzalo Fernández Hinojal
- Contact Person Email
- gfernandezh@unav.es
- Site Name
- Hospital Universitari Dexeus Grupo Quironsalud
- Department Name
- Oncology
- Principal Investigator Name
- Andres Aguilar Hernandez
- Principal Investigator Email
- aaguilar@oncorosell.com
- Contact Person Name
- Andres Aguilar Hernandez
- Contact Person Email
- aaguilar@oncorosell.com
- Site Name
- Institut Catala D'oncologia (Badalona)
- Department Name
- Oncology
- Principal Investigator Name
- Enric Carcereny Costa
- Principal Investigator Email
- ecarcereny@iconcologia.net
- Contact Person Name
- Enric Carcereny Costa
- Contact Person Email
- ecarcereny@iconcologia.net
Austria
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 16-10-2024
- Processing Time Days
- 26
- Number Of Sites
- 5
- Number Of Participants
- 12
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Universitätsklinik für Innere Medizin I
- Principal Investigator Name
- Thorsten Füreder
- Principal Investigator Email
- thorsten.fuereder@meduniwien.ac.at
- Contact Person Name
- Thorsten Füreder
- Contact Person Email
- thorsten.fuereder@meduniwien.ac.at
- Site Name
- Klinik Hietzing
- Department Name
- Abteilung für Atmungs-und Lungenerkrank ungen
- Principal Investigator Name
- Robab Breyer-Kohansal
- Principal Investigator Email
- robab.breyer-kohansal@lunghealth.lbg.ac.at
- Contact Person Name
- Robab Breyer-Kohansal
- Contact Person Email
- robab.breyer-kohansal@lunghealth.lbg.ac.at
- Site Name
- Ordensklinikum Linz GmbH
- Department Name
- Pneumologie
- Principal Investigator Name
- Michael Schumacher
- Principal Investigator Email
- michael.schumacher@ordensklinikum.at
- Contact Person Name
- Michael Schumacher
- Contact Person Email
- michael.schumacher@ordensklinikum.at
- Site Name
- Universitaetsklinikum Krems
- Department Name
- Pneumologie
- Principal Investigator Name
- Klaus Hackner
- Principal Investigator Email
- Klaus.hackner@krems.lknoe.at
- Contact Person Name
- Klaus Hackner
- Contact Person Email
- Klaus.hackner@krems.lknoe.at
- Site Name
- Stadt Wien Wiener Gesundheitsverbund
- Department Name
- Ambulanz für Innere Medizin und Pneumologie
- Principal Investigator Name
- Maximilian Hochmair
- Principal Investigator Email
- maximilian.hochmair@gesundheitsverbund.at
- Contact Person Name
- Maximilian Hochmair
- Contact Person Email
- maximilian.hochmair@gesundheitsverbund.at
Germany
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 07-10-2024
- Processing Time Days
- 17
- Number Of Sites
- 23
- Number Of Participants
- 23
Sites
- Site Name
- Kliniken der Stadt Koeln gGmbH
- Department Name
- Oncology Outpatient Clinic
- Principal Investigator Name
- Eva Lotte Buchmeier
- Principal Investigator Email
- buchmeiere@kliniken-koeln.de
- Contact Person Name
- Eva Lotte Buchmeier
- Contact Person Email
- buchmeiere@kliniken-koeln.de
- Site Name
- Ruppiner Kliniken GmbH
- Department Name
- Pneumology Department
- Principal Investigator Name
- Hagen Kelm
- Principal Investigator Email
- h.kelm@ruppiner-kliniken.de
- Contact Person Name
- Hagen Kelm
- Contact Person Email
- h.kelm@ruppiner-kliniken.de
- Site Name
- Bundeswehrkrankenhaus Ulm
- Department Name
- Hematology and Oncology
- Principal Investigator Name
- Matthias Müller
- Principal Investigator Email
- matthias27mueller@bundeswehr.org
- Contact Person Name
- Matthias Müller
- Contact Person Email
- matthias27mueller@bundeswehr.org
- Site Name
- Klinikum Esslingen GmbH
- Department Name
- Klinik fuer Kardiologie, Angiologie Und Pneumologie
- Principal Investigator Name
- Martin Fähling
- Principal Investigator Email
- m.faehling@klinikum-esslingen.de
- Contact Person Name
- Martin Fähling
- Contact Person Email
- m.faehling@klinikum-esslingen.de
- Site Name
- Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
- Department Name
- Onkologie und Onkologische Palliativmedizin
- Principal Investigator Name
- Karsten Schulmann
- Principal Investigator Email
- karsten.schulmann@lkhemer.de
- Contact Person Name
- Karsten Schulmann
- Contact Person Email
- karsten.schulmann@lkhemer.de
Norway
- Earliest CTIS Part Ii Submission Date
- 14-07-2025
- Latest Decision Or Authorization Date
- 31-07-2025
- Processing Time Days
- 17
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Vestre Viken HF
- Department Name
- Department of Surgery, Section of Oncology
- Principal Investigator Name
- Inger Johanne Zwicky Eide
- Principal Investigator Email
- ingei@vestreviken.no
- Contact Person Name
- Inger Johanne Zwicky Eide
- Contact Person Email
- ingei@vestreviken.no
Hungary
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 16-10-2024
- Processing Time Days
- 26
- Number Of Sites
- 7
- Number Of Participants
- 36
Sites
- Site Name
- Orszagos Koranyi Pulmonologiai Intezet
- Department Name
- Pulmonology
- Principal Investigator Name
- Gyula Ostoros
- Principal Investigator Email
- drostorosgyula@gmail.com
- Contact Person Name
- Gyula Ostoros
- Contact Person Email
- drostorosgyula@gmail.com
- Site Name
- Semmelweis University
- Department Name
- Pulmonology
- Principal Investigator Name
- Veronika Müller
- Principal Investigator Email
- muller.veronika@med.semmelweisuniv.hu
- Contact Person Name
- Veronika Müller
- Contact Person Email
- muller.veronika@med.semmelweisuniv.hu
- Site Name
- Matrai Gyogyintezet
- Department Name
- Pulmonology
- Principal Investigator Name
- László Urbán
- Principal Investigator Email
- drurban.laszlo@magy.eu
- Contact Person Name
- László Urbán
- Contact Person Email
- drurban.laszlo@magy.eu
- Site Name
- Reformatus Pulmonologiai Centrum
- Department Name
- Oncology
- Principal Investigator Name
- Éva Morócz
- Principal Investigator Email
- eva.morocz262@gmail.com
- Contact Person Name
- Éva Morócz
- Contact Person Email
- eva.morocz262@gmail.com
- Site Name
- Farkasgyepui Tudogyogyintezet
- Department Name
- Pulmonology
- 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
- Site Name
- Orszagos Onkologiai Intezet
- Department Name
- Oncology
- Principal Investigator Name
- Tünde Nagy
- Principal Investigator Email
- drnt@freemail.hu
- Contact Person Name
- Tünde Nagy
- Contact Person Email
- drnt@freemail.hu
- Site Name
- Matrai Gyogyintezet (additional site entry if present)
- Department Name
- Pulmonology
- Principal Investigator Name
- László Urbán
- Principal Investigator Email
- drurban.laszlo@magy.eu
- Contact Person Name
- László Urbán
- Contact Person Email
- drurban.laszlo@magy.eu
Netherlands
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 16-10-2024
- Processing Time Days
- 26
- Number Of Sites
- 7
- Number Of Participants
- 7
Sites
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Respiratory Deseases
- Principal Investigator Name
- C.A.A. Smits-van der Graaf
- Principal Investigator Email
- Chantal.Smits-vanderGraaf@radboudumc.nl
- Contact Person Name
- C.A.A. Smits-van der Graaf
- Contact Person Email
- Chantal.Smits-vanderGraaf@radboudumc.nl
- Site Name
- Ziekenhuis St Jansdal
- Department Name
- Department of pulmonology
- Principal Investigator Name
- Lisenka Boom
- Principal Investigator Email
- ln.boom@stjansdal.nl
- Contact Person Name
- Lisenka Boom
- Contact Person Email
- ln.boom@stjansdal.nl
- Site Name
- Haga Hospital
- Department Name
- -
- Principal Investigator Name
- Henk Codrington
- Principal Investigator Email
- h.codrington@hagaziekenhuis.nl
- Contact Person Name
- Henk Codrington
- Contact Person Email
- h.codrington@hagaziekenhuis.nl
- Site Name
- Albert Schweitzer Ziekenhuis
- Department Name
- -
- Principal Investigator Name
- Eric Van Thiel
- Principal Investigator Email
- ericvanthiel@asz.nl
- Contact Person Name
- Eric Van Thiel
- Contact Person Email
- ericvanthiel@asz.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Department of pulmonary oncology
- Principal Investigator Name
- Willemijn Theelen
- Principal Investigator Email
- w.theelen@nki.nl
- Contact Person Name
- Willemijn Theelen
- Contact Person Email
- w.theelen@nki.nl
- Site Name
- Sint Franciscus Vlietland Groep Stichting
- Department Name
- -
- Principal Investigator Name
- Wessel Hanselaar
- Principal Investigator Email
- w.hanselaar@franciscus.nl
- Contact Person Name
- Wessel Hanselaar
- Contact Person Email
- w.hanselaar@franciscus.nl
- Site Name
- Ziekenhuis St Jansdal (additional entry if present)
- Department Name
- Department of pulmonology
- Principal Investigator Name
- Lisenka Boom
- Principal Investigator Email
- ln.boom@stjansdal.nl
- Contact Person Name
- Lisenka Boom
- Contact Person Email
- ln.boom@stjansdal.nl
Romania
- Earliest CTIS Part Ii Submission Date
- 28-04-2025
- Latest Decision Or Authorization Date
- 11-08-2025
- Processing Time Days
- 105
- Number Of Sites
- 5
- Number Of Participants
- 25
Sites
- Site Name
- Oncocenter Oncologie Clinica S.R.L.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Roxana Ioana Scheusan
- Principal Investigator Email
- roxana.scheusan@gmail.com
- Contact Person Name
- Roxana Ioana Scheusan
- Contact Person Email
- roxana.scheusan@gmail.com
- Site Name
- Centrul De Oncologie-Euroclinic S.R.L.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Constantin Volovat
- Principal Investigator Email
- cvolovat@yahoo.com
- Contact Person Name
- Constantin Volovat
- Contact Person Email
- cvolovat@yahoo.com
- Site Name
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
- Department Name
- Medical Oncology II
- Principal Investigator Name
- Aurelia Alexandru
- Principal Investigator Email
- auralexandru@yahoo.com
- Contact Person Name
- Aurelia Alexandru
- Contact Person Email
- auralexandru@yahoo.com
- Site Name
- Medisprof S.R.L.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Anghel Adrian Udrea
- Principal Investigator Email
- drianudrea@medisprof.ro
- Contact Person Name
- Anghel Adrian Udrea
- Contact Person Email
- drianudrea@medisprof.ro
- Site Name
- Radiotherapy Center Cluj S.R.L.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Andrei Ungureanu
- Principal Investigator Email
- andrei.ungureanu@amethyst-radiotherapy.com
- Contact Person Name
- Andrei Ungureanu
- Contact Person Email
- andrei.ungureanu@amethyst-radiotherapy.com
Italy
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 08-10-2024
- Processing Time Days
- 18
- Number Of Sites
- 31
- Number Of Participants
- 31
Sites
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- S.C. Oncologia Clinica Sperimentale Toraco-Polmonare
- Principal Investigator Name
- Alessandro Morabito
- Principal Investigator Email
- a.morabito@istitutotumori.na.it
- Contact Person Name
- Alessandro Morabito
- Contact Person Email
- a.morabito@istitutotumori.na.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- U.O.C Oncologia Medica
- Principal Investigator Name
- Roberto Ferrara
- Principal Investigator Email
- ferrara.roberto@hsr.it
- Contact Person Name
- Roberto Ferrara
- Contact Person Email
- ferrara.roberto@hsr.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- U.O. Oncologia
- Principal Investigator Name
- Chiara Bennati
- Principal Investigator Email
- chiara.bennati@auslromagna.it
- Contact Person Name
- Chiara Bennati
- Contact Person Email
- chiara.bennati@auslromagna.it
Poland
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 13-10-2024
- Processing Time Days
- 23
- Number Of Sites
- 19
- Number Of Participants
- 19
Sites
- Site Name
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
- Department Name
- Oddział III – Chorób Płuc z Pododdziałem Onkologicznym
- Principal Investigator Name
- Aleksandra Szczesna
- Principal Investigator Email
- aszczesna@otwock-szpital.pl
- Contact Person Name
- Aleksandra Szczesna
- Contact Person Email
- aszczesna@otwock-szpital.pl
France
- Earliest CTIS Part Ii Submission Date
- 14-07-2025
- Latest Decision Or Authorization Date
- 08-08-2025
- Processing Time Days
- 25
- Number Of Sites
- 18
- Number Of Participants
- 70
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Medicine
- Principal Investigator Name
- Fabrice BARLESI
- Principal Investigator Email
- fabrice.barlesi@gustaveroussy.fr
- Contact Person Name
- Fabrice BARLESI
- Contact Person Email
- fabrice.barlesi@gustaveroussy.fr
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 07-10-2024
- Processing Time Days
- 17
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
- Department Name
- Department of Medical Oncology at Clinic of Clinical Hematology
- Principal Investigator Name
- Bozhil Robev
- Principal Investigator Email
- bostro@abv.bg
- Contact Person Name
- Bozhil Robev
- Contact Person Email
- bostro@abv.bg
Czechia
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 16-10-2024
- Processing Time Days
- 26
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Nemocnice AGEL Ostrava-Vitkovice a.s.
- Department Name
- Plicní oddělení
- Principal Investigator Name
- Jaromír Roubec
- Principal Investigator Email
- jaromir.roubec@gmail.com
- Contact Person Name
- Jaromír Roubec
- Contact Person Email
- jaromir.roubec@gmail.com
Greece
- Earliest CTIS Part Ii Submission Date
- 29-07-2025
- Latest Decision Or Authorization Date
- 04-08-2025
- Processing Time Days
- 6
- Number Of Sites
- 12
- Number Of Participants
- 36
Sites
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Dimitrios Mavroudis
- Principal Investigator Email
- mavroudis@uoc.gr
- Contact Person Name
- Dimitrios Mavroudis
- Contact Person Email
- mavroudis@uoc.gr
Denmark
- Earliest CTIS Part Ii Submission Date
- 11-07-2025
- Latest Decision Or Authorization Date
- 11-08-2025
- Processing Time Days
- 31
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Sygehus Soenderjylland Soenderborg
- Department Name
- Department of Oncology
- Principal Investigator Name
- Daniela Salopek Zitnjak
- Principal Investigator Email
- Daniela.Zitnjak@rsyd.dk
- Contact Person Name
- Daniela Salopek Zitnjak
- Contact Person Email
- Daniela.Zitnjak@rsyd.dk
Ireland
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 03-10-2024
- Processing Time Days
- 13
- Number Of Sites
- 8
- Number Of Participants
- 8
Sites
- Site Name
- University Hospital Waterford
- Department Name
- Department of Medical Oncology
- Principal Investigator Name
- Paula Calvert
- Principal Investigator Email
- paulam.calvert@hse.ie
- Contact Person Name
- Paula Calvert
- Contact Person Email
- paulam.calvert@hse.ie
Croatia
- Earliest CTIS Part Ii Submission Date
- 16-07-2025
- Latest Decision Or Authorization Date
- 06-08-2025
- Processing Time Days
- 21
- Number Of Sites
- 2
- Number Of Participants
- 15
Sites
- Site Name
- Klinicki bolnicki centar Sestre milosrdnice
- Department Name
- Department of Oncology and Nuclear Medicine
- Principal Investigator Name
- Jasmina Marić Brozić
- Principal Investigator Email
- jasmina.maric@kbcsm.hr
- Contact Person Name
- Jasmina Marić Brozić
- Contact Person Email
- jasmina.maric@kbcsm.hr
Finland
- Earliest CTIS Part Ii Submission Date
- 14-07-2025
- Latest Decision Or Authorization Date
- 04-08-2025
- Processing Time Days
- 21
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Docrates Oy
- Department Name
- Cancer Center
- Principal Investigator Name
- Tuomo Alanko
- Principal Investigator Email
- tuomo.alanko@docrates.com
- Contact Person Name
- Tuomo Alanko
- Contact Person Email
- tuomo.alanko@docrates.com
Sponsor
Primary sponsor
- Full Name
- Mirati Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Endpoint Clinical Inc.
- Name
- PRA Hellas CRO A.E.
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- SAE Processing
- Name
- Icon Clinical Research Limited
Third parties
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"SAE Processing","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Reception of all samples. Storage of PK + KRAS G12C samples. PD-L1, PD, KRAS G12C testings","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Resolution Bioscience Inc.","duties_or_roles":"Receives real time Pre-Screen ctDNA samples from sites for eligibility testing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"Adagrasib pharmacokinetic testing","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Storage of tumor tissue samples and ctDNA blood samples (for retrospective testing)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"TCRB sequencing testing of pharmacodynamic blood samples","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- KEYTRUDA 25 mg/mL concentrate for solution for infusion
- Active Substance
- PEMBROLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Authorised (marketing authorisation listed in product dictionary)
- Starting Dose
- 200 mg
- Dose Levels
- 200 mg IV Q3W
- Frequency
- Q3W
- Maximum Dose
- 4800 mg
- Investigational Product Name
- Adagrasib
- Active Substance
- ADAGRASIB
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Investigational (no EU marketing authorisation listed for trial product in product dictionary)
- Starting Dose
- 400 mg BID
- Dose Levels
- 400 mg BID; 600 mg BID
- Frequency
- BID
- Maximum Dose
- 600 mg BID
- Dose Escalation Increase
- 400 mg BID -> 600 mg BID
- Combination Treatment
- Yes
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