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
2 other identifiers
interventional
345
23 countries
274
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2020
Longer than P75 for phase_3
274 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2020
CompletedFirst Posted
Study publicly available on registry
March 11, 2020
CompletedStudy Start
First participant enrolled
June 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2022
CompletedResults Posted
Study results publicly available
May 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2026
ExpectedApril 30, 2026
April 1, 2026
2.2 years
March 5, 2020
April 17, 2023
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
AMG 510
EXPERIMENTALDocetaxel
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Active brain metastases
- Myocardial infarction within 6 months of study day 1
- Gastrointestinal (GI) tract disease causing the inability to take oral medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (274)
Pacific Cancer Medical Center Inc
Anaheim, California, 92801, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
Pacific Shores Medical Group Long Beach
Long Beach, California, 90813, United States
University of California Los Angeles
Los Angeles, California, 90095-1772, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
University of California at Davis Medical Center
Sacramento, California, 95817, United States
Ridley Tree Cancer Center
Santa Barbara, California, 93105, United States
University of California San Francisco Mission Hall
Stanford, California, 94305, United States
Harbor University of California Los Angeles Medical Center
Torrance, California, 90502, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Danbury Hospital
Norwalk, Connecticut, 06856, United States
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Washington Cancer Institute at MedStar Washington Hospital
Washington D.C., District of Columbia, 20010, United States
Florida Cancer Specialists - Fort Myers
Fort Myers, Florida, 33901, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Florida Cancer Specialists Research North
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists Research Panhandle
Tallahassee, Florida, 32308, United States
Emory University
Atlanta, Georgia, 30332, United States
Northside Hospital, Incorporated
Atlanta, Georgia, 30341, United States
Affiliated Oncologists, LLC
North Chicago, Illinois, 60064, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804, United States
Willis Knighton Cancer Center
Shreveport, Louisiana, 71103, United States
Maryland Oncology Hematology PA
Clinton, Maryland, 20735, United States
New York Cancer and Blood Specialists
Lowell, Massachusetts, 01854, United States
University of Michigan
Ann Arbor, Michigan, 48109-1274, United States
Center for Oncology Clinical Trials
Grand Rapids, Michigan, 49503, United States
Minnesota Oncology Hematology PA
Minneapolis, Minnesota, 55404, United States
HCA Midwest Health Kansas City
Kansas City, Missouri, 64132, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Summit Medical Group
Florham Park, New Jersey, 07932, United States
New York Oncology Hematology, PC
Albany, New York, 12208, United States
United States Oncology Regulatory Affairs Corporate Office
Albany, New York, 12208, United States
Northwell Health Monter Cancer Center
Lake Success, New York, 11042, United States
Montefiore Einstein Center for Cancer Care
The Bronx, New York, 10461, United States
James J Peters VA Medical Center
The Bronx, New York, 10468, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, 45219, United States
Northwest Cancer Specialists - Vancouver
Portland, Oregon, 97227, United States
Charleston Oncology
Charleston, South Carolina, 29414, United States
Saint Francis Hospital, Inc
Greenville, South Carolina, 29607, United States
Tennessee Oncology PLLC
Chattanooga, Tennessee, 37404, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
Texas Oncology-Bedford
Bedford, Texas, 76022, United States
Texas Oncology Baylor
Dallas, Texas, 75246, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
Valley Cancer Associates
Harlingen, Texas, 78550, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
US Oncology Research Investigational Products Center
Irving, Texas, 75063, United States
Hope Cancer Center
Tyler, Texas, 75701, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Blacktown Hospital
Blacktown, New South Wales, 2148, Australia
Chris OBrien Lifehouse
Camperdown, New South Wales, 2050, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
St John of God Healthcare
Subiaco, Western Australia, 6008, Australia
Institute Jules Bordet
Brussels, 1000, Belgium
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
Grand Hopital de Charleroi
Charleroi, 6000, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liege
Liège, 4000, Belgium
AZ Delta Campus Rumbeke
Roeselare, 8800, Belgium
Algemeen Ziekenhuis Nikolaas Campus Sint Niklaas
Sint-Niklaas, 9100, Belgium
Hospital de Caridade de Ijui
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, São Paulo, 01308-050, Brazil
Beneficencia Portuguesa de Sao Paulo
São Paulo, São Paulo, 01321-001, Brazil
Oncologia Rede D´Or
São Paulo, São Paulo, 04501-000, Brazil
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652-900, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José Do Rio Preto, São Paulo, 15090-000, Brazil
Fundacao Antonio Prudente - Hospital A C Camargo
São Paulo, São Paulo, 01509-900, Brazil
Centro de Tratamento de Tumores Botafogo
Rio de Janeiro, 22250-905, Brazil
Instituto Coi
Rio de Janeiro, 22793-080, Brazil
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Centre Hospitalier de L'Universite de Montreal Hopital Notre-Dame
Montreal, Quebec, H2X 3E4, Canada
Herlev og Gentofte Hospital
Herlev, 2730, Denmark
Rigshospitalet
København, 2100, Denmark
Odense Universitetshospital
Odense C, 5000, Denmark
Docrates Syopasairaala
Helsinki, 00180, Finland
Helsingin Yliopistollinen Keskussairaala
Helsinki, 00290, Finland
Oulu University Hospital
Oulu, 90220, Finland
Turku University Hospital
Turku, 20520, Finland
Centre Hospitalier Regional Universitaire - Hopital Morvan
Brest, 29609, France
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010, France
Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
Grenoble, 38700, France
Centre Hospitalier Universitaire Régional de Lille - Hôpital Albert Calmette
Lille, 59037, France
Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren
Limoges, 87042, France
Centre Leon Berard
Lyon, 69008, France
Centre Hospitalier Universitaire Nord
Marseille, 13915, France
Institut Curie
Paris, 75005, France
Hopital Cochin
Paris, 75014, France
Hopital Bichat Claude Bernard
Paris, 75018, France
Hôpital Tenon
Paris, 75020, France
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
Pessac, 33604, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, 35033, France
Centre Hospitalier de Nantes - Hôpital Nord LaÃ"nnec
Saint-Herblain, 44800, France
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
Strasbourg, 67091, France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse, 31059, France
Gustave Roussy
Villejuif, 94805, France
Evangelische Lungenklinik
Berlin, 13125, Germany
Charite Universitätsmedizin Berlin, Charité Campus Virchow-Klinikum
Berlin, 13353, Germany
Universitaetsklinikum Carl Gustav Carus
Dresden, 01307, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730, Germany
Universitätsklinikum Frankfurt/Main
Frankfurt am Main, 60590, Germany
Asklepios - Fachkliniken München-Gauting
Gauting, 82130, Germany
LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927, Germany
Studiengesellschaft Hämato Onkologie Hamburg Prof Laack und Partner
Hamburg, 20251, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69126, Germany
Klinikverbund Allgäu
Immenstadt im Allgäu, 87509, Germany
Universitatsklinikum Koln
Köln, 50937, Germany
Pneumologisch/onkologisch/internistisches Studienzentrum
Leipzig, 04357, Germany
Bethanien Krankenhaus
Moers, 47441, Germany
Pius-Hospital Oldenburg
Oldenburg, 26121, Germany
Agios Savvas Anticancer Hospital
Athens, 115 22, Greece
Henry Dunant Hospital Center
Athens, 11526, Greece
Sotiria General Hospital
Athens, 11527, Greece
General Oncology Hospital of Kifissia Agioi Anargyroi
Athens, 14564, Greece
Metropolitan Hospital
Athens, 18547, Greece
University Hospital of Heraklion
Heraklion - Crete, 71110, Greece
University Hospital of Larissa
Larissa, 41110, Greece
University Hospital of Patras
Pátrai, 26504, Greece
Theagenion Cancer Hospital
Thessaloniki, 54007, Greece
Bioclinic of Thessaloniki
Thessaloniki, 54622, Greece
Euromedica General Clinic of Thessaloniki
Thessaloniki, 54645, Greece
Agios Loukas Clinic
Thessaloniki, 55236, Greece
Semmelweis Egyetem
Budapest, 1083, Hungary
Orszagos Koranyi Pulmonologiai Intezet
Budapest, 1121, Hungary
Veszprem Megyei Tudogyogyintezet
Farkasgyepű, 8582, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula, 5700, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400, Hungary
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
Miskolc, 3529, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000, Hungary
Szent Borbala Korhaz
Tatabánya, 2800, Hungary
Tudogyogyintezet Torokbalint
Törökbálint, 2045, Hungary
Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati
Avellino, 83100, Italy
IRCCS Istituto Tumori Giovanni Paolo II
Bari, 70124, Italy
Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico
Catania, 95123, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, 50134, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula
Monserrato CA, 09042, Italy
Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo
Monza (MB), 20900, Italy
Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi
Naples, 80131, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano (TO), 10043, Italy
Istituto Oncologico Veneto IRCCS
Padova, 35128, Italy
Azienda Unità Sanitaria Locale della Romagna Presidio ospedaliero di Ravenna
Ravenna, 48100, Italy
Azienda Ospedaliera Policlinico Umberto I
Roma, 00161, Italy
Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
Chiba Cancer Center
Chiba, Chiba, 260-8717, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, Fukuoka, 807-8556, Japan
Chugoku Central Hospital of Japan Mutual Aid Association of Public School Teachers
Fukuyama-shi, Hiroshima, 720-0001, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Hyogo Cancer Center
Akashi-shi, Hyōgo, 673-8558, Japan
National Hospital Organization Himeji Medical Center
Himeji-shi, Hyōgo, 670-8520, Japan
Itami City Hospital
Itami-shi, Hyōgo, 664-8540, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
St Marianna University School of Medicine Hospital
Kawasaki-shi, Kanagawa, 216-8511, Japan
Kitasato University Hospital
Sagamihara-shi, Kanagawa, 252-0375, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Kyoto University Hospital
Kyoto, Kyoto, 606-8507, Japan
Miyagi Cancer Center
Natori-shi, Miyagi, 981-1293, Japan
Sendai Kousei Hospital
Sendai, Miyagi, 980-0873, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566, Japan
Okayama University Hospital
Okayama, Okayama-ken, 700-8558, Japan
Osaka Habikino Medical Center
Habikino-shi, Osaka, 583-8588, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191, Japan
Osaka City General Hospital
Osaka, Osaka, 534-0021, Japan
Osaka International Cancer Institute
Osaka, Osaka, 541-8567, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, 589-8511, Japan
National Hospital Organization Kinki-chuo Chest Medical Center
Sakai-shi, Osaka, 591-8555, Japan
Saga-ken Medical Centre Koseikan
Saga, Saga-ken, 840-8571, Japan
Saitama Cancer Center
Kitaadachi-gun, Saitama, 362-0806, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, 520-2192, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550, Japan
Tottori University Hospital
Yonago-shi, Tottori, 683-8504, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510, Japan
National Hospital Organization Iwakuni Clinical Center
Iwakuni-shi, Yamaguchi, 740-8510, Japan
National Hospital Organization Yamaguchi Ube Medical Center
Ube-shi, Yamaguchi, 755-0241, Japan
Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
Amsterdam, 1066 CX, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Radboudumc
Nijmegen, 6525 GA, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
Instytut Genetyki i Immunologii GENIM Spzoo
Lublin, 20-609, Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu
Poznan, 60-569, Poland
Centrum Onkologii Instytut im Marii Sklodowskiej-Curie
Warsaw, 02-781, Poland
Dolnoslaskie Centrum Onkologii we Wroclawiu
Wroclaw, 53-413, Poland
Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente
Lisbon, 1769-001, Portugal
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality, 4464-513, Portugal
Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio
Porto, 4099-001, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072, Portugal
Centro Hospitalar Universitario de Sao Joao EPE - Hospital Sao Joao
Porto, 4200-319, Portugal
Clinical hospital 2, Group of companies medsi
Moscow, 125284, Russia
LLC Tonus
Nizhny Novgorod, 603089, Russia
Omsk Regional Clinical Oncology Dispensary
Omsk, 644013, Russia
FSBI Scientific and Research Oncology Institute named after N N Petrov
Saint Petersburg, 197758, Russia
Saint Petersburg scientifical practical center of specialized kinds of medical care oncological
Saint Petersburg, 197758, Russia
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do, 28644, South Korea
National Cancer Center
Goyang-si Gyeonggi-do, 10408, South Korea
Cha Bundang Medical Center, Cha University
Seongnam-si, Gyeonggi-do, 13496, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung medical center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
Hospital Regional Universitario de Malaga
Málaga, AndalucÃ-a, 29011, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Canary Islands, 35016, Spain
Hospital Universitari Vall d Hebron
Barcelona, Cataluña, 08035, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Cataluña, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Cataluña, 08041, Spain
Instituto Catalan de Oncologia Hospital Duran i Reynals
L'Hospitalet de Llobregat, Cataluña, 08907, Spain
Complexo Hospitalario Universitario A Coruña Hospital Teresa Herrera
A Coruña, Galicia, 15006, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Clinico Universitario de Valencia
Valencia, Valencia, 46010, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Gavle Sjukhus
Gävle, 801 87, Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45, Sweden
Universitetssjukhuset i Linkoping
Linköping, 581 85, Sweden
Skanes Universitetssjukhus
Lund, 221 85, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, 171 64, Sweden
Norrlands Universitetssjukhus
Umeå, 901 85, Sweden
Universitaetsspital Basel
Basel, 4031, Switzerland
Inselspital Bern
Bern, 3010, Switzerland
Hopitaux Universitaires de Geneve
Geneva, 1205, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011, Switzerland
Kantonsspital Winterthur
Winterthur, 8401, Switzerland
Universitaetsspital Zuerich
Zurich, 8091, Switzerland
China Medical University Hospital
Taichung, 40447, Taiwan
Veterans General Hospital - Taichung
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Sarah Cannon Research Institute UK
London, W1G 6AD, United Kingdom
Christie Hospital
Manchester, M20 4BX, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Churchill Hospital
Oxford, OX3 7LJ, United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
Related Publications (6)
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.
PMID: 39303400BACKGROUNDSkoulidis 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.
PMID: 39846981BACKGROUNDSkoulidis F, Li BT, de Langen AJ, Hong DS, Lena H, Wolf J, Dy GK, Curioni Fontecedro A, Tomasini P, Velcheti V, van der Wekken AJ, Dooms C, Paz-Ares Rodriguez L, Mountzios G, Sacher A, Nadal E, Couraud S, Kim SW, O'Byrne K, Rocco D, Toyozawa R, Chmielewska I, Lindsay CR, Hindoyan A, Mukundan L, Wilmanski T, Anderson A, Ardito-Abraham C, Pati A, Reddy A, Mehta B, Schuler M. Molecular determinants of sotorasib clinical efficacy in KRASG12C-mutated non-small-cell lung cancer. Nat Med. 2025 Aug;31(8):2755-2767. doi: 10.1038/s41591-025-03732-5. Epub 2025 May 28.
PMID: 40437272BACKGROUNDde 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 KRAS G12C-mutated non-small-cell lung cancer: a plain language summary. Future Oncol. 2025 Apr;21(9):1033-1044. doi: 10.1080/14796694.2025.2474789. Epub 2025 Mar 24.
PMID: 40129223BACKGROUNDDingemans AC, Syrigos K, Livi L, Paulus A, Kim SW, Chen Y, Felip E, Griesinger F, Ohashi K, Zalcman G, Hughes BGM, Sorensen JB, Blais N, Ferreira CGM, Lindsay CR, Dziadziuszko R, Ward PJ, Obiozor CC, Wang Y, Peters S. Intracranial activity of sotorasib vs docetaxel in pretreated KRAS G12C-mutated advanced non-small cell lung cancer from a global, phase 3, randomized controlled trial. Lung Cancer. 2025 Sep;207:108683. doi: 10.1016/j.lungcan.2025.108683. Epub 2025 Jul 29.
PMID: 40774040BACKGROUNDde 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.
PMID: 36764316DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
March 5, 2020
First Posted
March 11, 2020
Study Start
June 4, 2020
Primary Completion
August 2, 2022
Study Completion (Estimated)
June 24, 2026
Last Updated
April 30, 2026
Results First Posted
May 10, 2023
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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
- 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.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request