Clinical trial NCT04303780: Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
Official title: A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: KRAS p, G12c Mutated /Advanced Metastatic NSCLC
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2020-03-11
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation


Eligibility criteria: Inclusion Criteria:

* Men or women greater than or equal to 18 years old.
* ECOG ≤ 1
* Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment

Exclusion Criteria:

* Active brain metastases
* Myocardial infarction within 6 months of study day 1
* Gastrointestinal (GI) tract disease causing the inability to take oral medication

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Baseline up to primary analysis data cut-off date (02 August 2022); max time on study as of primary analysis data cut off was 24.3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center Inc
state: California
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group Long Beach
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Sacramento
country: United States
facility: University of California at Davis Medical Center
state: California
city: Santa Barbara
country: United States
facility: Ridley Tree Cancer Center
state: California
city: Stanford
country: United States
facility: University of California San Francisco Mission Hall
state: California
city: Torrance
country: United States
facility: Harbor University of California Los Angeles Medical Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Norwalk
country: United States
facility: Danbury Hospital
state: Connecticut
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants Helen F Graham Cancer Center
state: Delaware
city: Washington
country: United States
facility: Washington Cancer Institute at MedStar Washington Hospital
state: District of Columbia
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - Fort Myers
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists Research North
state: Florida
city: Tallahassee
country: United States
facility: Florida Cancer Specialists Research Panhandle
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital, Incorporated
state: Georgia
city: North Chicago
country: United States
facility: Affiliated Oncologists, LLC
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology
state: Indiana
city: Shreveport
country: United States
facility: Willis Knighton Cancer Center
state: Louisiana
city: Clinton
country: United States
facility: Maryland Oncology Hematology PA
state: Maryland
city: Lowell
country: United States
facility: New York Cancer and Blood Specialists
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Center for Oncology Clinical Trials
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology PA
state: Minnesota
city: Kansas City
country: United States
facility: HCA Midwest Health Kansas City
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Florham Park
country: United States
facility: Summit Medical Group
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology, PC
state: New York
city: Albany
country: United States
facility: United States Oncology Regulatory Affairs Corporate Office
state: New York
city: Bronx
country: United States
facility: Montefiore Einstein Center for Cancer Care
state: New York
city: Bronx
country: United States
facility: James J Peters VA Medical Center
state: New York
city: Lake Success
country: United States
facility: Northwell Health Monter Cancer Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care Inc
state: Ohio
city: Portland
country: United States
facility: Northwest Cancer Specialists - Vancouver
state: Oregon
city: Charleston
country: United States
facility: Charleston Oncology
state: South Carolina
city: Greenville
country: United States
facility: Saint Francis Hospital, Inc
state: South Carolina
city: Chattanooga
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Bedford
country: United States
facility: Texas Oncology-Bedford
state: Texas
city: Dallas
country: United States
facility: Texas Oncology Baylor
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Harlingen
country: United States
facility: Valley Cancer Associates
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Irving
country: United States
facility: US Oncology Research Investigational Products Center
state: Texas
city: Tyler
country: United States
facility: Hope Cancer Center
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Blacktown
country: Australia
facility: Blacktown Hospital
state: New South Wales
city: Camperdown
country: Australia
facility: Chris OBrien Lifehouse
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Chermside
country: Australia
facility: Prince Charles Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Subiaco
country: Australia
facility: St John of God Healthcare
state: Western Australia
city: Brussels
country: Belgium
facility: Institute Jules Bordet
city: Bruxelles
country: Belgium
facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege
city: Roeselare
country: Belgium
facility: AZ Delta Campus Rumbeke
city: Sint-Niklaas
country: Belgium
facility: Algemeen Ziekenhuis Nikolaas Campus Sint Niklaas
city: Ijui
country: Brazil
facility: Hospital de Caridade de Ijui
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes
state: SÃ£o Paulo
city: Sao Paulo
country: Brazil
facility: Beneficencia Portuguesa de Sao Paulo
state: SÃ£o Paulo
city: Sao Paulo
country: Brazil
facility: Oncologia Rede DÂ´Or
state: SÃ£o Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
state: SÃ£o Paulo
city: SÃ£o JosÃ© Do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose do Rio Preto
state: SÃ£o Paulo
city: Rio de Janeiro
country: Brazil
facility: Centro de Tratamento de Tumores Botafogo
city: Rio de Janeiro
country: Brazil
facility: Instituto Coi
city: SÃ£o Paulo
country: Brazil
facility: Fundacao Antonio Prudente - Hospital A C Camargo
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de L'Universite de Montreal Hopital Notre-Dame
state: Quebec
city: Herlev
country: Denmark
facility: Herlev og Gentofte Hospital
city: KÃ¸benhavn
country: Denmark
facility: Rigshospitalet
city: Odense C
country: Denmark
facility: Odense Universitetshospital
city: Helsinki
country: Finland
facility: Docrates Syopasairaala
city: Helsinki
country: Finland
facility: Helsingin Yliopistollinen Keskussairaala
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Brest
country: France
facility: Centre Hospitalier Regional Universitaire - Hopital Morvan
city: CrÃ©teil
country: France
facility: Centre Hospitalier Intercommunal de CrÃ©teil
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
city: Lille Cedex
country: France
facility: Centre Hospitalier Universitaire RÃ©gional de Lille - HÃ´pital Albert Calmette
city: Limoges Cedex
country: France
facility: Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille Cedex 20
country: France
facility: Centre Hospitalier Universitaire Nord
city: Paris Cedex 20
country: France
facility: HÃ´pital Tenon
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Hopital Bichat Claude Bernard
city: Pessac Cedex
country: France
facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
city: Pierre-Benite cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
city: Saint Herblain
country: France
facility: Centre Hospitalier de Nantes - HÃ´pital Nord LaÃ"nnec
city: Strasbourg cedex
country: France
facility: Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
city: Toulouse Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
city: Villejuif
country: France
facility: Gustave Roussy
city: Berlin
country: Germany
facility: Evangelische Lungenklinik
city: Berlin
country: Germany
facility: Charite UniversitÃ¤tsmedizin Berlin, CharitÃ© Campus Virchow-Klinikum
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus
city: Essen
country: Germany
facility: UniversitÃ¤tsklinikum Essen
city: Esslingen am Neckar
country: Germany
facility: Klinikum Esslingen GmbH
city: Frankfurt am Main
country: Germany
facility: UniversitÃ¤tsklinikum Frankfurt/Main
city: Gauting
country: Germany
facility: Asklepios - Fachkliniken MÃ¼nchen-Gauting
city: Grosshansdorf
country: Germany
facility: LungenClinic Grosshansdorf GmbH
city: Hamburg
country: Germany
facility: Studiengesellschaft HÃ¤mato Onkologie Hamburg Prof Laack und Partner
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Immenstadt
country: Germany
facility: Klinikverbund AllgÃ¤u
city: KÃ¶ln
country: Germany
facility: Universitatsklinikum Koln
city: Leipzig
country: Germany
facility: Pneumologisch/onkologisch/internistisches Studienzentrum
city: Moers
country: Germany
facility: Bethanien Krankenhaus
city: Oldenburg
country: Germany
facility: Pius-Hospital Oldenburg
city: Athens
country: Greece
facility: Agios Savvas Anticancer Hospital
city: Athens
country: Greece
facility: Henry Dunant Hospital Center
city: Athens
country: Greece
facility: Sotiria General Hospital
city: Athens
country: Greece
facility: General Oncology Hospital of Kifissia Agioi Anargyroi
city: Athens
country: Greece
facility: Metropolitan Hospital
city: Heraklion - Crete
country: Greece
facility: University Hospital of Heraklion
city: Larissa
country: Greece
facility: University Hospital of Larissa
city: Patra
country: Greece
facility: University Hospital of Patras
city: Thessaloniki
country: Greece
facility: Theagenion Cancer Hospital
city: Thessaloniki
country: Greece
facility: Bioclinic of Thessaloniki
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic of Thessaloniki
city: Thessaloniki
country: Greece
facility: Agios Loukas Clinic
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet
city: Farkasgyepu
country: Hungary
facility: Veszprem Megyei Tudogyogyintezet
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
city: Kaposvar
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Tatabanya
country: Hungary
facility: Szent Borbala Korhaz
city: Torokbalint
country: Hungary
facility: Tudogyogyintezet Torokbalint
city: Avellino
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati
city: Bari
country: Italy
facility: IRCCS Istituto Tumori Giovanni Paolo II
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi
city: Catania
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Monserrato CA
country: Italy
facility: Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula
city: Monza (MB)
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo
city: Napoli
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi
city: Orbassano (TO)
country: Italy
facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS
city: Ravenna
country: Italy
facility: Azienda UnitÃ Sanitaria Locale della Romagna Presidio ospedaliero di Ravenna
city: Roma
country: Italy
facility: Azienda Ospedaliera Policlinico Umberto I
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital
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: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health
state: Fukuoka
city: Fukuyama-shi
country: Japan
facility: Chugoku Central Hospital of Japan Mutual Aid Association of Public School Teachers
state: Hiroshima
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Akashi-shi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Himeji-shi
country: Japan
facility: National Hospital Organization Himeji Medical Center
state: Hyogo
city: Itami-shi
country: Japan
facility: Itami City Hospital
state: Hyogo
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Kawasaki-shi
country: Japan
facility: St Marianna University School of Medicine Hospital
state: Kanagawa
city: Sagamihara-shi
country: Japan
facility: Kitasato University Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital
state: Kyoto
city: Natori-shi
country: Japan
facility: Miyagi Cancer Center
state: Miyagi
city: Sendai-shi
country: Japan
facility: Sendai Kousei Hospital
state: Miyagi
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Okayama-shi
country: Japan
facility: Okayama University Hospital
state: Okayama
city: Habikino-shi
country: Japan
facility: Osaka Habikino Medical Center
state: Osaka
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka City General Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Sakai-shi
country: Japan
facility: National Hospital Organization Kinki-chuo Chest Medical Center
state: Osaka
city: Saga-shi
country: Japan
facility: Saga-ken Medical Centre Koseikan
state: Saga
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Otsu-shi
country: Japan
facility: Shiga University of Medical Science Hospital
state: Shiga
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: Cancer Institute Hospital of Japanese Foundation for Cancer Research
state: Tokyo
city: Yonago-shi
country: Japan
facility: Tottori University Hospital
state: Tottori
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital
state: Wakayama
city: Iwakuni-shi
country: Japan
facility: National Hospital Organization Iwakuni Clinical Center
state: Yamaguchi
city: Ube-shi
country: Japan
facility: National Hospital Organization Yamaguchi Ube Medical Center
state: Yamaguchi
city: Cheongju-si, Chungcheongbuk-do
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Goyang-si Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Seongnam-si, Gyeonggi-do
country: Korea, Republic of
facility: Cha Bundang Medical Center, Cha University
city: Seongnam-si, Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
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: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Amsterdam
country: Netherlands
facility: Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Lublin
country: Poland
facility: Instytut Genetyki i Immunologii GENIM Spzoo
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu
city: Warszawa
country: Poland
facility: Centrum Onkologii Instytut im Marii Sklodowskiej-Curie
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii we Wroclawiu
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente
city: Matosinhos
country: Portugal
facility: Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario de Sao Joao EPE - Hospital Sao Joao
city: Moscow
country: Russian Federation
facility: Clinical hospital 2, Group of companies medsi
city: Nizhniy Novgorod
country: Russian Federation
facility: LLC Tonus
city: Omsk
country: Russian Federation
facility: Omsk Regional Clinical Oncology Dispensary
city: Saint-Petersburg
country: Russian Federation
facility: FSBI Scientific and Research Oncology Institute named after N N Petrov
city: Saint-Petersburg
country: Russian Federation
facility: Saint Petersburg scientifical practical center of specialized kinds of medical care oncological
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
state: AndalucÃ-a
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran Canaria
state: Canarias
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron
state: CataluÃ±a
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
state: CataluÃ±a
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: CataluÃ±a
city: Hospitalet de Llobregat
country: Spain
facility: Instituto Catalan de Oncologia Hospital Duran i Reynals
state: CataluÃ±a
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
state: Comunidad Valenciana
city: A CoruÃ±a
country: Spain
facility: Complexo Hospitalario Universitario A CoruÃ±a Hospital Teresa Herrera
state: Galicia
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Gavle
country: Sweden
facility: Gavle Sjukhus
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Linkoping
country: Sweden
facility: Universitetssjukhuset i Linkoping
city: Lund
country: Sweden
facility: Skanes Universitetssjukhus
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
city: Umea
country: Sweden
facility: Norrlands Universitetssjukhus
city: Basel
country: Switzerland
facility: Universitaetsspital Basel
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Geneve
country: Switzerland
facility: Hopitaux Universitaires de Geneve
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zurich
country: Switzerland
facility: Universitaetsspital Zuerich
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Veterans General Hospital - Taichung
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Waterhouse DM, Rothschild S, Dooms C, Mennecier B, Bozorgmehr F, Majem M, van den Heuvel MH, Linardou H, Chul Cho B, Roberts-Thomson R, Tanaka K, Blais N, Schvartsman G, Holmskov Hansen K, Chmielewska I, Forster MD, Giannopoulou C, Stollenwerk B, Obiozor CC, Wang Y, Novello S. Patient-reported outcomes in CodeBreaK 200: Sotorasib versus docetaxel for previously treated advanced NSCLC with KRAS G12C mutation. Lung Cancer. 2024 Oct;196:107921. doi: 10.1016/j.lungcan.2024.107921. Epub 2024 Aug 6.
citation: Skoulidis F, Li BT, Hochmair M, Govindan R, Vincent M, van der Wekken AJ, Reguart Aransay N, O'Byrne KJ, Girard N, Griesinger F, Nishio M, Hafliger S, Lindsay C, Reinmuth N, Paulus A, Papakotoulas P, Kim SW, Ferreira CG, Pasello G, Duruisseaux M, Gennatas S, Dimou A, Mehta B, Kormany W, Nduka C, Sylvester BE, Ardito-Abraham C, Wang Y, de Langen AJ. Pooled safety analysis and management of sotorasib-related adverse events in KRAS G12C-mutated advanced non-small cell lung cancer. Oncologist. 2025 Jan 17;30(1):oyae356. doi: 10.1093/oncolo/oyae356.