Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: KRAS p, G12c Mutated /Advanced Metastatic NSCLC
• Intervention / Treatment: Drug: AMG 510; Drug: Docetaxel

• Study Type: Interventional
• Enrollment (Actual): 345
• Phase: Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Blacktown Hospital
    • Camperdown, New South Wales, Australia, 2050
      • Chris Obrien Lifehouse
    • Kogarah, New South Wales, Australia, 2217
      • St George Hospital
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • Prince Charles Hospital
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • South Australia
    • Woodville South, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Centre
  • Western Australia
    • Subiaco, Western Australia, Australia, 6008
      • St John of God Healthcare
• Belgium
  • Brussels, Belgium, 1000
    • Institute Jules Bordet
  • Bruxelles, Belgium, 1200
    • Universite Catholique de Louvain Cliniques Universitaires Saint Luc
  • Charleroi, Belgium, 6000
    • Grand Hôpital de Charleroi
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Leuven, Belgium, 3000
    • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
  • Liege, Belgium, 4000
    • Centre Hospitalier Universitaire de Liege
  • Roeselare, Belgium, 8800
    • AZ Delta Campus Rumbeke
  • Sint-Niklaas, Belgium, 9100
    • Algemeen Ziekenhuis Nikolaas Campus Sint Niklaas
• Brazil
  • Rio de Janeiro, Brazil, 22793-080
    • Instituto Coi
  • Rio de Janeiro, Brazil, 22250-905
    • Centro de Tratamento de Tumores Botafogo
  • São Paulo, Brazil, 01509-900
    • Fundacao Antonio Prudente - Hospital A C Camargo
  • Rio Grande Do Sul
    • Ijui, Rio Grande Do Sul, Brazil, 98700-000
      • Hospital de Caridade de Ijui
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
  • São Paulo
    • Sao Paulo, São Paulo, Brazil, 01308-050
      • Sociedade Beneficente de Senhoras Hospital Sirio Libanes
    • Sao Paulo, São Paulo, Brazil, 01321-001
      • Beneficencia Portuguesa de Sao Paulo
    • Sao Paulo, São Paulo, Brazil, 04501-000
      • Oncologia Rede D´Or
    • Sao Paulo, São Paulo, Brazil, 05652-900
      • Hospital Israelita Albert Einstein
    • São José Do Rio Preto, São Paulo, Brazil, 15090-000
      • Hospital de Base de Sao Jose do Rio Preto
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Centre
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Centre
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital Cancer Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Centre Hospitalier de L'Universite de Montreal Hopital Notre-Dame
• Denmark
  • Herlev, Denmark, 2730
    • Herlev og Gentofte Hospital
  • København, Denmark, 2100
    • Rigshospitalet
  • Odense C, Denmark, 5000
    • Odense Universitetshospital
• Finland
  • Helsinki, Finland, 00290
    • Helsingin Yliopistollinen Keskussairaala
  • Helsinki, Finland, 00180
    • Docrates Syopasairaala
  • Oulu, Finland, 90220
    • Oulu University Hospital
  • Turku, Finland, 20520
    • Turku University Hospital
• France
  • Brest, France, 29609
    • Centre Hospitalier Regional Universitaire - Hopital Morvan
  • Créteil, France, 94010
    • Centre Hospitalier Intercommunal de Créteil
  • Grenoble, France, 38700
    • Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
  • Lille Cedex, France, 59037
    • Centre Hospitalier Universitaire Régional de Lille - Hôpital Albert Calmette
  • Limoges Cedex, France, 87042
    • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
  • Lyon, France, 69008
    • Centre Leon Berard
  • Marseille Cedex 20, France, 13915
    • Centre Hospitalier Universitaire Nord
  • Paris, France, 75014
    • Hopital Cochin
  • Paris, France, 75005
    • Institut Curie
  • Paris, France, 75018
    • Hopital Bichat Claude Bernard
  • Paris Cedex 20, France, 75020
    • Hôpital Tenon
  • Pessac Cedex, France, 33604
    • Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
  • Pierre-Benite cedex, France, 69495
    • Centre Hospitalier Lyon Sud
  • Rennes, France, 35033
    • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
  • Saint Herblain, France, 44800
    • Centre Hospitalier de Nantes - Hôpital Nord LaÃ"nnec
  • Strasbourg cedex, France, 67091
    • Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
  • Toulouse Cedex 9, France, 31059
    • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
  • Villejuif, France, 94805
    • Gustave Roussy
• Germany
  • Berlin, Germany, 13125
    • Evangelische Lungenklinik
  • Berlin, Germany, 13353
    • Charite Universitätsmedizin Berlin, Charité Campus Virchow-Klinikum
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus
  • Essen, Germany, 45147
    • Universitätsklinikum Essen
  • Esslingen am Neckar, Germany, 73730
    • Klinikum Esslingen GmbH
  • Frankfurt am Main, Germany, 60590
    • Universitätsklinikum Frankfurt/Main
  • Gauting, Germany, 82130
    • Asklepios - Fachkliniken München-Gauting
  • Grosshansdorf, Germany, 22927
    • LungenClinic Grosshansdorf GmbH
  • Hamburg, Germany, 20251
    • Studiengesellschaft Hämato Onkologie Hamburg Prof Laack und Partner
  • Heidelberg, Germany, 69126
    • Universitaetsklinikum Heidelberg
  • Immenstadt, Germany, 87509
    • Klinikverbund Allgäu
  • Köln, Germany, 50937
    • Universitatsklinikum Koln
  • Leipzig, Germany, 04357
    • Pneumologisch/onkologisch/internistisches Studienzentrum
  • Moers, Germany, 47441
    • Bethanien Krankenhaus
  • Oldenburg, Germany, 26121
    • Pius-Hospital Oldenburg
• Greece
  • Athens, Greece, 18547
    • Metropolitan Hospital
  • Athens, Greece, 115 22
    • Agios Savvas Anticancer Hospital
  • Athens, Greece, 11526
    • Henry Dunant Hospital Center
  • Athens, Greece, 11527
    • Sotiria General Hospital
  • Athens, Greece, 14564
    • General Oncology Hospital of Kifissia Agioi Anargyroi
  • Heraklion - Crete, Greece, 71110
    • University Hospital of Heraklion
  • Larissa, Greece, 41110
    • University Hospital Of Larissa
  • Patra, Greece, 26504
    • University Hospital of Patras
  • Thessaloniki, Greece, 54622
    • Bioclinic of Thessaloniki
  • Thessaloniki, Greece, 54007
    • Theagenion Cancer Hospital
  • Thessaloniki, Greece, 54645
    • EUROMEDICA General Clinic of Thessaloniki
  • Thessaloniki, Greece, 55236
    • Agios Loukas Clinic
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem
  • Budapest, Hungary, 1121
    • Orszagos Koranyi Pulmonologiai Intezet
  • Farkasgyepu, Hungary, 8582
    • Veszprem Megyei Tudogyogyintezet
  • Gyula, Hungary, 5700
    • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
  • Kaposvar, Hungary, 7400
    • Somogy Megyei Kaposi Mór Oktató Kórház
  • Miskolc, Hungary, 3529
    • Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
  • Szekesfehervar, Hungary, 8000
    • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Tatabanya, Hungary, 2800
    • Szent Borbala Korhaz
  • Torokbalint, Hungary, 2045
    • Tudogyogyintezet Torokbalint
• Italy
  • Avellino, Italy, 83100
    • Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati
  • Bari, Italy, 70124
    • Irccs Istituto Tumori Giovanni Paolo Ii
  • Bologna, Italy, 40138
    • Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi
  • Catania, Italy, 95123
    • Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico
  • Firenze, Italy, 50134
    • Azienda Ospedaliero Universitaria Careggi
  • Milano, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Milano, Italy, 20132
    • IRCCS Ospedale San Raffaele
  • Milano, Italy, 20122
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
  • Monserrato CA, Italy, 09042
    • Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula
  • Monza (MB), Italy, 20900
    • Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo
  • Napoli, Italy, 80131
    • Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi
  • Orbassano (TO), Italy, 10043
    • Azienda Ospedaliera Universitaria San Luigi Gonzaga
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto IRCCS
  • Ravenna, Italy, 48100
    • Azienda Unità Sanitaria Locale della Romagna Presidio ospedaliero di Ravenna
  • Roma, Italy, 00168
    • Policlinico Universitario Agostino Gemelli
  • Roma, Italy, 00161
    • Azienda Ospedaliera Policlinico Umberto I
• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan, 466-8560
      • Nagoya University Hospital
    • Nagoya-shi, Aichi, Japan, 464-8681
      • Aichi Cancer Center Hospital
  • Chiba
    • Chiba-shi, Chiba, Japan, 260-8717
      • Chiba Cancer Center
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Ehime
    • Matsuyama-shi, Ehime, Japan, 791-0280
      • National Hospital Organization Shikoku Cancer Center
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 812-8582
      • Kyushu University Hospital
    • Fukuoka-shi, Fukuoka, Japan, 811-1395
      • National Hospital Organization Kyushu Cancer Center
    • Kitakyushu-shi, Fukuoka, Japan, 807-8556
      • Hospital of the University of Occupational and Environmental Health
  • Hiroshima
    • Fukuyama-shi, Hiroshima, Japan, 720-0001
      • Chugoku Central Hospital of Japan Mutual Aid Association of Public School Teachers
    • Hiroshima-shi, Hiroshima, Japan, 734-8551
      • Hiroshima University Hospital
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 003-0804
      • National Hospital Organization Hokkaido Cancer Center
  • Hyogo
    • Akashi-shi, Hyogo, Japan, 673-8558
      • Hyogo Cancer Center
    • Himeji-shi, Hyogo, Japan, 670-8520
      • National Hospital Organization Himeji Medical Center
    • Itami-shi, Hyogo, Japan, 664-8540
      • Itami City Hospital
    • Kobe-shi, Hyogo, Japan, 650-0047
      • Kobe City Medical Center General Hospital
  • Ishikawa
    • Kanazawa-shi, Ishikawa, Japan, 920-8641
      • Kanazawa University Hospital
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 216-8511
      • St Marianna University School of Medicine Hospital
    • Sagamihara-shi, Kanagawa, Japan, 252-0375
      • Kitasato University Hospital
    • Yokohama-shi, Kanagawa, Japan, 241-8515
      • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
  • Kyoto
    • Kyoto-shi, Kyoto, Japan, 606-8507
      • Kyoto University Hospital
  • Miyagi
    • Natori-shi, Miyagi, Japan, 981-1293
      • Miyagi Cancer Center
    • Sendai-shi, Miyagi, Japan, 980-0873
      • Sendai Kousei Hospital
  • Niigata
    • Niigata-shi, Niigata, Japan, 951-8566
      • Niigata Cancer Center Hospital
  • Okayama
    • Okayama-shi, Okayama, Japan, 700-8558
      • Okayama University Hospital
  • Osaka
    • Habikino-shi, Osaka, Japan, 583-8588
      • Osaka Habikino Medical Center
    • Hirakata-shi, Osaka, Japan, 573-1191
      • Kansai Medical University Hospital
    • Osaka-shi, Osaka, Japan, 541-8567
      • Osaka International Cancer Institute
    • Osaka-shi, Osaka, Japan, 534-0021
      • Osaka City General Hospital
    • Osakasayama-shi, Osaka, Japan, 589-8511
      • Kindai University Hospital
    • Sakai-shi, Osaka, Japan, 591-8555
      • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Saga
    • Saga-shi, Saga, Japan, 840-8571
      • Saga-Ken Medical Centre Koseikan
  • Saitama
    • Kitaadachi-gun, Saitama, Japan, 362-0806
      • Saitama Cancer Center
  • Shiga
    • Otsu-shi, Shiga, Japan, 520-2192
      • Shiga University of Medical Science Hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
    • Koto-ku, Tokyo, Japan, 135-8550
      • Cancer Institute Hospital of Japanese Foundation for Cancer Research
  • Tottori
    • Yonago-shi, Tottori, Japan, 683-8504
      • Tottori University Hospital
  • Wakayama
    • Wakayama-shi, Wakayama, Japan, 641-8510
      • Wakayama Medical University Hospital
  • Yamaguchi
    • Iwakuni-shi, Yamaguchi, Japan, 740-8510
      • National Hospital Organization Iwakuni Clinical Center
    • Ube-shi, Yamaguchi, Japan, 755-0241
      • National Hospital Organization Yamaguchi Ube Medical Center
• Korea, Republic of
  • Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
    • Chungbuk National University Hospital
  • Goyang-si Gyeonggi-do, Korea, Republic of, 10408
    • National Cancer Center
  • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
    • CHA Bundang Medical Center, CHA University
  • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea Seoul St Marys Hospital
  • Ulsan, Korea, Republic of, 44033
    • Ulsan University Hospital
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen
  • Nijmegen, Netherlands, 6525 GA
    • Radboudumc
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus Medisch Centrum
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht
• Poland
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne
  • Lublin, Poland, 20-609
    • Instytut Genetyki i Immunologii GENIM Spzoo
  • Poznan, Poland, 60-569
    • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu
  • Warszawa, Poland, 02-781
    • Centrum Onkologii Instytut im Marii Sklodowskiej-Curie
  • Wroclaw, Poland, 53-413
    • Dolnoslaskie Centrum Onkologii we Wroclawiu
• Portugal
  • Lisboa, Portugal, 1769-001
    • Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente
  • Matosinhos, Portugal, 4464-513
    • Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
  • Porto, Portugal, 4200-072
    • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio
  • Porto, Portugal, 4200-319
    • Centro Hospitalar Universitario de Sao Joao EPE - Hospital Sao Joao
• Russian Federation
  • Moscow, Russian Federation, 125284
    • Clinical hospital 2, Group of companies medsi
  • Nizhniy Novgorod, Russian Federation, 603089
    • LLC Tonus
  • Omsk, Russian Federation, 644013
    • Omsk Regional Clinical Oncology Dispensary
  • Saint-Petersburg, Russian Federation, 197758
    • FSBI Scientific and Research Oncology Institute named after N N Petrov
  • Saint-Petersburg, Russian Federation, 197758
    • Saint Petersburg scientifical practical center of specialized kinds of medical care oncological
• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • AndalucÃ-a
    • Malaga, AndalucÃ-a, Spain, 29011
      • Hospital Regional Universitario de Malaga
  • Canarias
    • Las Palmas de Gran Canaria, Canarias, Spain, 35016
      • Hospital Universitario Insular de Gran Canaria
  • Cataluña
    • Barcelona, Cataluña, Spain, 08041
      • Hospital de La Santa Creu i Sant Pau
    • Barcelona, Cataluña, Spain, 08035
      • Hospital Universitari Vall D Hebron
    • Barcelona, Cataluña, Spain, 08036
      • Hospital Clinic i Provincial de Barcelona
    • Hospitalet de Llobregat, Cataluña, Spain, 08907
      • Instituto Catalan de Oncologia Hospital Duran i Reynals
  • Comunidad Valenciana
    • Valencia, Comunidad Valenciana, Spain, 46010
      • Hospital Clínico Universitario de Valencia
  • Galicia
    • A Coruña, Galicia, Spain, 15006
      • Complexo Hospitalario Universitario A Coruña Hospital Teresa Herrera
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro Majadahonda
• Sweden
  • Gavle, Sweden, 801 87
    • Gavle Sjukhus
  • Goteborg, Sweden, 413 45
    • Sahlgrenska Universitetssjukhuset
  • Linkoping, Sweden, 581 85
    • Universitetssjukhuset i Linköping
  • Lund, Sweden, 221 85
    • Skanes universitetssjukhus
  • Stockholm, Sweden, 171 64
    • Karolinska Universitetssjukhuset Solna
  • Umea, Sweden, 901 85
    • Norrlands Universitetssjukhus
• Switzerland
  • Basel, Switzerland, 4031
    • Universitaetsspital Basel
  • Bern, Switzerland, 3010
    • Inselspital Bern
  • Geneve, Switzerland, 1205
    • Hopitaux universitaires de Geneve
  • Lausanne, Switzerland, 1011
    • Centre Hospitalier Universitaire Vaudois
  • Winterthur, Switzerland, 8401
    • Kantonsspital Winterthur
  • Zurich, Switzerland, 8091
    • Universitaetsspital Zuerich
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Veterans General Hospital - Taichung
  • Tainan, Taiwan, 70403
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital
  • London, United Kingdom, W1G 6AD
    • Sarah Cannon Research Institute UK
  • Manchester, United Kingdom, M20 4BX
    • Christie Hospital
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham City Hospital
  • Oxford, United Kingdom, OX3 7LJ
    • Churchill Hospital
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hospital
• United States
  • California
    • Anaheim, California, United States, 92801
      • Pacific Cancer Medical Center Inc
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center
    • Long Beach, California, United States, 90813
      • Pacific Shores Medical Group Long Beach
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
    • Los Angeles, California, United States, 90095-1772
      • University of California Los Angeles
    • Sacramento, California, United States, 95817
      • University of California at Davis Medical Center
    • Santa Barbara, California, United States, 93105
      • Ridley Tree Cancer Center
    • Stanford, California, United States, 94305
      • University of California San Francisco Mission Hall
    • Torrance, California, United States, 90502
      • Harbor University of California Los Angeles Medical Center
  • Colorado
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers
  • Connecticut
    • Norwalk, Connecticut, United States, 06856
      • Danbury Hospital
  • Delaware
    • Newark, Delaware, United States, 19713
      • Medical Oncology Hematology Consultants Helen F Graham Cancer Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Cancer Institute at MedStar Washington Hospital
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists - Fort Myers
    • Hollywood, Florida, United States, 33021
      • Memorial Regional Hospital
    • Saint Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists Research North
    • Tallahassee, Florida, United States, 32308
      • Florida Cancer Specialists Research Panhandle
  • Georgia
    • Atlanta, Georgia, United States, 30332
      • Emory University
    • Atlanta, Georgia, United States, 30341
      • Northside Hospital, Incorporated
  • Illinois
    • North Chicago, Illinois, United States, 60064
      • Affiliated Oncologists, LLC
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Medical Oncology and Hematology
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Willis Knighton Cancer Center
  • Maryland
    • Clinton, Maryland, United States, 20735
      • Maryland Oncology Hematology PA
  • Massachusetts
    • Lowell, Massachusetts, United States, 01854
      • New York Cancer and Blood Specialists
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-1274
      • University of Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Center for Oncology Clinical Trials
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Minnesota Oncology Hematology PA
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • HCA Midwest Health Kansas City
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada
  • New Jersey
    • Florham Park, New Jersey, United States, 07932
      • Summit Medical Group
  • New York
    • Albany, New York, United States, 12208
      • New York Oncology Hematology, PC
    • Albany, New York, United States, 12208
      • United States Oncology Regulatory Affairs Corporate Office
    • Bronx, New York, United States, 10468
      • James J Peters VA Medical Center
    • Bronx, New York, United States, 10461
      • Montefiore Einstein Center for Cancer Care
    • Lake Success, New York, United States, 11042
      • Northwell Health Monter Cancer Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Oncology Hematology Care Inc
  • Oregon
    • Portland, Oregon, United States, 97227
      • Northwest Cancer Specialists - Vancouver
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Oncology
    • Greenville, South Carolina, United States, 29607
      • Saint Francis Hospital, Inc
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Tennessee Oncology PLLC
    • Knoxville, Tennessee, United States, 37909
      • Tennessee Cancer Specialists
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology
  • Texas
    • Bedford, Texas, United States, 76022
      • Texas Oncology-Bedford
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75246
      • Texas Oncology Baylor
    • Fort Worth, Texas, United States, 76104
      • The Center for Cancer and Blood Disorders
    • Harlingen, Texas, United States, 78550
      • Valley Cancer Associates
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center
    • Irving, Texas, United States, 75063
      • US Oncology Research Investigational Products Center
    • Tyler, Texas, United States, 75701
      • Hope Cancer Center
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Docetaxel	Drug: Docetaxel; 21 day cycles
Experimental: AMG 510	Drug: AMG 510; 21 day cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	PFS was defined as the time from randomization (baseline) until disease progression or death from any cause, whichever occurred first for all participants. Progression was based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). As pre-specified in the statistical analysis plan, for participants who crossed over from docetaxel to AMG 510, the participant's response post first progression or post crossover was not used for the primary analyses. Data are presented per original treatment randomized.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Defined as time from randomization to death by any cause	Baseline to approximately 6 years
Objective Response Rate (ORR)	Defined as complete response (CR ) + partial response (PR)	Baseline to approximately 6 years
Patient Reported Outcomes (PRO)	To be assessed by Patient-reported symptoms from selected PRO-Common Terminology Criteria for Adverse Events questions and GP5 of Functional Assessment of Cancer Therapy Tool General form (FACT-G)	Baseline to week 12
Quality of Life Assessment	To be as assessed by: European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 13 (EORTC QLQ-LC13) and European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ C30)	Baseline to week 12
Duration of response (DOR)	Defined as time from first evidence of PR or CR to disease progression or death due to any cause, whichever occurs first.	Baseline to approximately 6 years
Time to response (TTR)	Defined as time from randomization to first evidence of PR or CR	Baseline to approximately 6 years
Disease control rate (DCR)	Defined as rate of confirmed objective response (CR or PR) + stable disease (SD) per Response Evaluation Criteria in Solid Tumors version (RECIST) v1.1 of at least 6 weeks	Baseline to approximately 6 years
Number of subjects with Clinically significant changes in vital signs		Approximately 1 year
Number of subjects with treatment-emergent adverse events		Estimated up to approximately 6 years
Number of subjects with Clinically significant changes in Laboratory tests		Estimated up to approximately 1 year
Number of Subjects with treatment-related adverse events		Estimated up to 6 years
Maximum plasma concentration (Cmax)	To characterize the pharmacokinetics (PK) of AMG 510	Estimated up to 4 months
Area under the plasma concentration-time curve (AUC)	To characterize the pharmacokinetics (PK) of AMG 510	Estimated up to 4 months

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

General Publications

• de Langen AJ, Johnson ML, Mazieres J, Dingemans AC, Mountzios G, Pless M, Wolf J, Schuler M, Lena H, Skoulidis F, Yoneshima Y, Kim SW, Linardou H, Novello S, van der Wekken AJ, Chen Y, Peters S, Felip E, Solomon BJ, Ramalingam SS, Dooms C, Lindsay CR, Ferreira CG, Blais N, Obiozor CC, Wang Y, Mehta B, Varrieur T, Ngarmchamnanrith G, Stollenwerk B, Waterhouse D, Paz-Ares L; CodeBreaK 200 Investigators. Sotorasib versus docetaxel for previously treated non-small-cell lung cancer with KRASG12C mutation: a randomised, open-label, phase 3 trial. Lancet. 2023 Mar 4;401(10378):733-746. doi: 10.1016/S0140-6736(23)00221-0. Epub 2023 Feb 7.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2020
• Primary Completion (Actual): August 2, 2022
• Study Completion (Estimated): April 27, 2026

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Docetaxel; Sotorasib
• Other Study ID Numbers: 20190009; 2023-508214-42-00 (Other Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No