Clinical trial NCT06252649: Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation
Official title: Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Metastatic Colorectal Cancer
Keywords: Sotorasib
Panitumumab
FOLFIRI
Bevacizumab-awwb
Oncology
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-02-12
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare progression free survival (PFS) in treatment-naïve Participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.


Eligibility criteria: Inclusion Criteria:

* Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
* Central confirmation of KRAS p.G12C mutation
* Measurable metastatic disease per RECIST v1.1 criteria.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
* Adequate organ function.

Exclusion Criteria:

* Active, untreated brain metastases.
* Leptomeningeal disease
* Previous treatment with a KRAS p.G12C inhibitor
* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan

Primary outcomes:
measure: PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
timeFrame: Up to Approximately 3 Years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to Approximately 5 Years
measure: Objective Response (OR) per RECIST v1.1
timeFrame: Up to Approximately 3 Years
measure: Duration of Response (DOR) per RECIST v1.1
timeFrame: Up to Approximately 3 Years
measure: Disease Control Rate (DCR) per RECIST v1.1
timeFrame: up to Approximately 3 Years
measure: Time to Response (TTR) per RECIST v1.1
timeFrame: Up to approximately 3 Years
measure: Depth of Response per RECIST v1.1
timeFrame: Up to Approximately 3 Years
measure: Time to Early Tumor Shrinkage (ETS) per RECIST v1.1
timeFrame: Up to Approximately 3 Years
measure: PFS Based on Investigator's Assessment per RECIST v1.1
timeFrame: Up to Approximately 3 Years
measure: Objective Response Rate (ORR) Based on Investigator's Assessment per RECIST v1.1
timeFrame: Up to Approximately 3 years
measure: DOR Based on Investigator's Assessment per RECIST v1.1
timeFrame: up to Approximately 3 Years
measure: DCR Based on Investigator's Assessment per RECIST v1.1
timeFrame: Up to Approximately 3 Years
measure: TTR Based on Investigator's Assessment per RECIST v1.1
timeFrame: Up to Approximately 3 Years
measure: Depth of Response Based on Investigator's Assessment per RECIST v1.1
timeFrame: Up to Approximately 3 Years
measure: Time to ETS Based on Investigator's Assessment per RECIST v1.1
timeFrame: Up to Approximately 3 Years
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to Approximately 3 Years
measure: Pre-dose (Ctrough) Concentrations of Sotorasib
timeFrame: Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)
measure: Maximum Plasma Concentration (Cmax) of Sotorasib
timeFrame: Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer and Research Centers Scottsdale
state: Arizona
city: Fullerton
country: United States
facility: Providence Saint Jude Medical Center
state: California
city: Los Alamitos
country: United States
facility: Cancer and Blood Specialty Clinic
state: California
city: Los Angeles
country: United States
facility: California Research Institute
state: California
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Margate
country: United States
facility: D and H Cancer Research Center
state: Florida
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology Centers PA
state: Florida
city: Plantation
country: United States
facility: Boca Raton Clinical Research Medical Center Inc
state: Florida
city: Atlanta
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Hinsdale
country: United States
facility: Hope and Healing Cancer Services
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc
state: Illinois
city: Pikeville
country: United States
facility: Pikeville Medical Center
state: Kentucky
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan
state: Michigan
city: Bridgeton
country: United States
facility: Saint Louis Cancer Care West County
state: Missouri
city: Mickleton
country: United States
facility: Minniti Center for Medical Oncology and Hematology
state: New Jersey
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Cancer Center
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Rock Hill
country: United States
facility: Carolina Blood and Cancer Care
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Oncology PLLC - Chattanooga
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Caba
country: Argentina
facility: Hospital Universitario Fundacion Favaloro
state: Buenos Aires
city: Caba
country: Argentina
facility: Instituto Argentino de Diagnóstico y Tratamiento
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigaciones Clinicas Moleculares - Centro de Endocrinologia y Diabetes Dr Raul Gutman SRL
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Cemic
state: Buenos Aires
city: La Plata
country: Argentina
facility: Sanatorio Británico de Rosario
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Instituto de Investigaciones clinicas de Mar del Plata
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Hospital Italiano de Córdoba
state: Córdoba
city: Cordoba
country: Argentina
facility: Sanatorio Allende
state: Córdoba
city: Cordoba
country: Argentina
facility: Clinica Universitaria Privada Reina Fabiola
state: Córdoba
city: Viedma
country: Argentina
facility: Clinica Viedma
state: Río Negro
city: San Miguel de Tucuman
country: Argentina
facility: Exelsus Oncologia Clinica
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral
city: Camperdown
country: Australia
facility: Chris OBrien Lifehouse
state: New South Wales
city: Toowoomba
country: Australia
facility: Toowoomba Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Heidelberg
country: Australia
facility: Austin Health, Austin Hospital
state: Victoria
city: Graz
country: Austria
facility: Medizinische Universitaet Graz
city: Linz
country: Austria
facility: Ordensklinikum Linz Barmherzige Schwestern
city: Rankweil
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Wien
country: Austria
facility: Universitaetsklinikum Allgemeines Krankenhaus Wien
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Bruxelles
country: Belgium
facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi - Site des Viviers
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg
city: Mechelen
country: Belgium
facility: Algemeen Ziekenhuis Sint-Maarten
city: Roeselare
country: Belgium
facility: AZ Delta Campus Rumbeke
city: Sint-Niklaas
country: Belgium
facility: Vitaz campus Sint-Niklaas Moerland
city: Brasilia
country: Brazil
facility: Hospital Sirio Libanes
state: Distrito Federal
city: Cachoeiro de Itapemirim
country: Brazil
facility: Hospital Evangelico de Cachoeiro de Itapemirim
state: Espírito Santo
city: Teresina
country: Brazil
facility: Vencer e Oncoclinica
state: Piauí
city: Natal
country: Brazil
facility: Liga Norte-Riograndense Contra O Cancer
state: Rio Grande Do Norte
city: Ijui
country: Brazil
facility: Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Associação Hospitalar Moinhos de Vento
state: Rio Grande Do Sul
city: Itajai
country: Brazil
facility: Clinica de Neoplasias Litoral
state: Santa Catarina
city: Barretos
country: Brazil
facility: Fundacao Pio 12 Hospital de Amor de Barretos
state: São Paulo
city: Barretos
country: Brazil
facility: Oncoclinicas Belo Horizonte
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente AC Camargo Cancer Center
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Oncologia Rede D Or
state: São Paulo
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose do Rio Preto
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Oncoclinicas Rio de Janeiro S A
city: São Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp
city: São Paulo
country: Brazil
facility: Instituto Brasileiro de Controle do Cancer Ibcc
city: Haskovo
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
city: Plovdiv
country: Bulgaria
facility: Complex Oncology Center Plovdiv EOOD
city: Sofia
country: Bulgaria
facility: Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Serdika EOOD
city: Temuco
country: Chile
facility: James Lind Centro de Investigacion del Cancer
state: Cautín
city: Temuco
country: Chile
facility: Centro de investigacion y desarrollo oncolgico Spa
state: Cautín
city: Providencia
country: Chile
facility: Enroll SpA
state: Santiago
city: Vitacura
country: Chile
facility: Clinica Redsalud Vitacura, Instituto del Cancer
state: Santiago
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez
city: Santiago
country: Chile
facility: Centro de oncologia de precision Spa
city: Santiago
country: Chile
facility: Biocinetic servicios medicos limitada
city: Valdivia
country: Chile
facility: Clinical Research Chile SpA
city: Rionegro
country: Colombia
facility: Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA
state: Antioquia
city: Bogota
country: Colombia
facility: Instituto Nacional de Cancerologia
state: Cundinamarca
city: Bogotá
country: Colombia
facility: Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic
state: Cundinamarca
city: Montería
country: Colombia
facility: Instituto Medico de Alta Tecnologia sas - Imat sas
state: Córdoba
city: Floridablanca
country: Colombia
facility: Fundacion Oftalmologica de Santander - Foscal
state: Santander
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Aalborg
country: Denmark
facility: Aalborg Sygehus
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Odense C
country: Denmark
facility: Odense University Hospital
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Clermont-Ferrand cedex 1
country: France
facility: Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Dijon Cedex
country: France
facility: Centre Hospitalier Universitaire de Dijon - Hopital du Bocage
city: Lyon
country: France
facility: Hopital Prive Jean Mermoz
city: Montpellier Cedex 5
country: France
facility: Institut regional du Cancer Montpellier
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris Cedex 10
country: France
facility: Hopital Saint Louis
city: Paris Cedex 13
country: France
facility: Hopital Pitie-Salpetriere
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Pessac
country: France
facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
city: Poitiers Cedex
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Reims
country: France
facility: Hopital Robert Debre
city: Rennes Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
city: Saint Priest en Jarez
country: France
facility: Centre Hospitalier Universitaire Nord de Saint Etienne - Hopital Nord
city: Saint-Herblain Cedex
country: France
facility: Institut de Cancerologie de l Ouest Rene Gauducheau
city: Vandoeuvre les Nancy Cedex
country: France
facility: Institut de Cancerologie de Lorraine - Alexis Vautrin
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin, Campus Virchow
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Dresden
country: Germany
facility: Universitaetsklinikum Dresden
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Frankfurt am Main
country: Germany
facility: UCT Universitaeres Zentrum fuer Tumorerkrankungen Frankfurt
city: Hamburg
country: Germany
facility: Haematologisch Onkologische Praxis Eppendorf
city: Ludwigsburg
country: Germany
facility: Regional Kliniken Holding Klinikum Ludwigsburg
city: Muenchen
country: Germany
facility: Klinikum der LMU Muenchen
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Wolfsburg
country: Germany
facility: Klinikum der Stadt Wolfsburg
city: Athens
country: Greece
facility: General Hospital Evangelismos
city: Athens
country: Greece
facility: Agios Savvas Anticancer Hospital
city: Athens
country: Greece
facility: Hygeia Hospital
city: Athens
country: Greece
facility: Metropolitan Hospital
city: Larissa
country: Greece
facility: University Hospital of Larissa
city: Piraeus
country: Greece
facility: Metaxa Anticancer Hospital
city: Thessaloniki
country: Greece
facility: Bioclinic of Thessaloniki
city: Thessaloniki
country: Greece
facility: Agios Loukas Clinic
city: Thessaloniki
country: Greece
facility: Saint Lukes Hospital SA
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, The University of Hong Kong
city: Kowloon
country: Hong Kong
facility: Princess Margaret Hospital
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Gyula
country: Hungary
facility: Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
city: Kaposvar
country: Hungary
facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
city: Brescia
country: Italy
facility: Istituto Ospedaliero Fondazione Poliambulanza
city: Castellana Grotte
country: Italy
facility: Ente Ospedaliero IRCCS Saverio De Bellis
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Foggia
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Palermo
country: Italy
facility: Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Santa Maria della Misericordia
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona Ospedale Civile Maggiore Borgo Trento
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Chiba-shi
country: Japan
facility: Chiba Cancer Center
state: Chiba
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama-shi
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Akashi-shi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Kawasaki-shi
country: Japan
facility: St Marianna University Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
state: Kanagawa
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: National Hospital Organization Osaka National Hospital
state: Osaka
city: Suita-shi
country: Japan
facility: The University of Osaka Hospital
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Tokushima-shi
country: Japan
facility: Tokushima University Hospital
state: Tokushima
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research
state: Tokyo
city: Goyang-si Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Marys Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Benito Juárez
country: Mexico
facility: Centro Especializado en Investigacion y Tratamiento Oncologicos SC
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Health Pharma Professional Research SA de CV
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr Jose Eleuterio Gonzalez
state: Nuevo León
city: Amsterdam
country: Netherlands
facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
city: Almada
country: Portugal
facility: Unidade de Saude Local de Almada-Seixal, EPE - Hospital Garcia de Orta
city: Coimbra
country: Portugal
facility: Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE
city: Coimbra
country: Portugal
facility: Unidade Local de Saude de Coimbra, EPE
city: Lisboa
country: Portugal
facility: Hospital Cuf Tejo
city: Lisboa
country: Portugal
facility: Fundacao Champalimaud
city: Lisboa
country: Portugal
facility: Hospital da Luz, SA
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
city: Matosinhos
country: Portugal
facility: Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
city: Santa Maria da Feira
country: Portugal
facility: Unidade Local de Saude de Entre Douro e Vouga, EPE - Hospital de Sao Sebastiao
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni
city: Bucuresti
country: Romania
facility: Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
city: Craiova
country: Romania
facility: Centrul de Oncologie Sf Nectarie SRL
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Ploiesti
country: Romania
facility: Spitalul Municipal Ploiesti
city: Timisoara
country: Romania
facility: SC Oncomed SRL
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Andalucía
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
state: Andalucía
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
state: Andalucía
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
state: Castilla León
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Cataluña
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
state: Comunidad Valenciana
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
state: Galicia
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Stockholm
country: Sweden
facility: Södersjukhuset, onkologikliniken
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zuerich
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Adana
country: Turkey
facility: Adana Sehir Egitim ve Arastirma Hastanesi
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi
city: Ankara
country: Turkey
facility: Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Hastanesi
city: Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi
city: Edirne
country: Turkey
facility: Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
city: Istanbul
country: Turkey
facility: Bezmialem Vakif Universitesi Hastanesi
city: Istanbul
country: Turkey
facility: Bagcilar Medipol Mega Universite Hastanesi
city: Istanbul
country: Turkey
facility: Acibadem Altunizade Hastanesi
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi
city: Konya
country: Turkey
facility: Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
city: Malatya
country: Turkey
facility: Inonu Universitesi Turgut Ozal Tip Merkezi
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: