KRAS p, G12c Mutated /Advanced Metastatic NSCLCPhase 3NCT04303780
Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
A Phase 3 study testing AMG 510 and Docetaxel in people with KRAS p, G12c Mutated /Advanced Metastatic NSCLC, run by Amgen at 274 sites in 23 countries.
Trial summary
A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- KRAS p, G12c Mutated /Advanced Metastatic NSCLC
- What is being tested?
- AMG 510 and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 274 sitesin 23 countries
- Study dates
- 4 Jun 2020to 24 Jun 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active brain metastases
- Myocardial infarction within 6 months of study day 1
- Gastrointestinal (GI) tract disease causing the inability to take oral medication
Trial locations and contacts
274 sites in 23 countries.
274 sites in 23 countries
United States54 sites
New York Oncology Hematology, PC
Albany, New York, 12208
United States Oncology Regulatory Affairs Corporate Office
Albany, New York, 12208
Pacific Cancer Medical Center Inc
Anaheim, California, 92801
University of Michigan
Ann Arbor, Michigan, 48109-1274
Emory University
Atlanta, Georgia, 30332
Northside Hospital, Incorporated
Atlanta, Georgia, 30341
Texas Oncology-Bedford
Bedford, Texas, 76022
Charleston Oncology
Charleston, South Carolina, 29414
Tennessee Oncology PLLC
Chattanooga, Tennessee, 37404
Oncology Hematology Care Inc
Cincinnati, Ohio, 45219
Maryland Oncology Hematology PA
Clinton, Maryland, 20735
Texas Oncology Baylor
Dallas, Texas, 75246
UT Southwestern Medical Center
Dallas, Texas, 75390
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
City of Hope National Medical Center
Duarte, California, 91010
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Summit Medical Group
Florham Park, New Jersey, 07932
Florida Cancer Specialists - Fort Myers
Fort Myers, Florida, 33901
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
Center for Oncology Clinical Trials
Grand Rapids, Michigan, 49503
Saint Francis Hospital, Inc
Greenville, South Carolina, 29607
Valley Cancer Associates
Harlingen, Texas, 78550
Memorial Regional Hospital
Hollywood, Florida, 33021
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
US Oncology Research Investigational Products Center
Irving, Texas, 75063
HCA Midwest Health Kansas City
Kansas City, Missouri, 64132
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909
Northwell Health Monter Cancer Center
Lake Success, New York, 11042
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Pacific Shores Medical Group Long Beach
Long Beach, California, 90813
University of California Los Angeles
Los Angeles, California, 90095-1772
University of California Los Angeles
Los Angeles, California, 90095
New York Cancer and Blood Specialists
Lowell, Massachusetts, 01854
Minnesota Oncology Hematology PA
Minneapolis, Minnesota, 55404
Intermountain Medical Center
Murray, Utah, 84107
Tennessee Oncology
Nashville, Tennessee, 37203
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark, Delaware, 19713
Virginia Oncology Associates
Norfolk, Virginia, 23502
Affiliated Oncologists, LLC
North Chicago, Illinois, 60064
Danbury Hospital
Norwalk, Connecticut, 06856
Northwest Cancer Specialists - Vancouver
Portland, Oregon, 97227
University of California at Davis Medical Center
Sacramento, California, 95817
Ridley Tree Cancer Center
Santa Barbara, California, 93105
Willis Knighton Cancer Center
Shreveport, Louisiana, 71103
Florida Cancer Specialists Research North
St. Petersburg, Florida, 33705
University of California San Francisco Mission Hall
Stanford, California, 94305
Florida Cancer Specialists Research Panhandle
Tallahassee, Florida, 32308
Montefiore Einstein Center for Cancer Care
The Bronx, New York, 10461
James J Peters VA Medical Center
The Bronx, New York, 10468
Harbor University of California Los Angeles Medical Center
Torrance, California, 90502
Hope Cancer Center
Tyler, Texas, 75701
Washington Cancer Institute at MedStar Washington Hospital
Washington D.C., District of Columbia, 20010
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Japan40 sites
Hyogo Cancer Center
Akashi-shi, Hyōgo, 673-8558
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Chiba Cancer Center
Chiba, Chiba, 260-8717
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Chugoku Central Hospital of Japan Mutual Aid Association of Public School Teachers
Fukuyama-shi, Hiroshima, 720-0001
Osaka Habikino Medical Center
Habikino-shi, Osaka, 583-8588
National Hospital Organization Himeji Medical Center
Himeji-shi, Hyōgo, 670-8520
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
Itami City Hospital
Itami-shi, Hyōgo, 664-8540
National Hospital Organization Iwakuni Clinical Center
Iwakuni-shi, Yamaguchi, 740-8510
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
St Marianna University School of Medicine Hospital
Kawasaki-shi, Kanagawa, 216-8511
Saitama Cancer Center
Kitaadachi-gun, Saitama, 362-0806
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, Fukuoka, 807-8556
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550
Kyoto University Hospital
Kyoto, Kyoto, 606-8507
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Miyagi Cancer Center
Natori-shi, Miyagi, 981-1293
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566
Okayama University Hospital
Okayama, Okayama-ken, 700-8558
Osaka City General Hospital
Osaka, Osaka, 534-0021
Osaka International Cancer Institute
Osaka, Osaka, 541-8567
Kindai University Hospital
Osakasayama-shi, Osaka, 589-8511
Shiga University of Medical Science Hospital
Ōtsu, Shiga, 520-2192
Saga-ken Medical Centre Koseikan
Saga, Saga-ken, 840-8571
Kitasato University Hospital
Sagamihara-shi, Kanagawa, 252-0375
National Hospital Organization Kinki-chuo Chest Medical Center
Sakai-shi, Osaka, 591-8555
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
Sendai Kousei Hospital
Sendai, Miyagi, 980-0873
National Hospital Organization Yamaguchi Ube Medical Center
Ube-shi, Yamaguchi, 755-0241
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
Tottori University Hospital
Yonago-shi, Tottori, 683-8504
France18 sites
Centre Hospitalier Regional Universitaire - Hopital Morvan
Brest, 29609
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
Grenoble, 38700
Centre Hospitalier Universitaire Régional de Lille - Hôpital Albert Calmette
Lille, 59037
Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren
Limoges, 87042
Centre Leon Berard
Lyon, 69008
Centre Hospitalier Universitaire Nord
Marseille, 13915
Institut Curie
Paris, 75005
Hopital Cochin
Paris, 75014
Hopital Bichat Claude Bernard
Paris, 75018
Hôpital Tenon
Paris, 75020
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
Pessac, 33604
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, 35033
Centre Hospitalier de Nantes - Hôpital Nord LaÃ"nnec
Saint-Herblain, 44800
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
Strasbourg, 67091
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse, 31059
Gustave Roussy
Villejuif, 94805
Italy16 sites
Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati
Avellino, 83100
IRCCS Istituto Tumori Giovanni Paolo II
Bari, 70124
Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi
Bologna, 40138
Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico
Catania, 95123
Azienda Ospedaliero Universitaria Careggi
Florence, 50134
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122
IRCCS Ospedale San Raffaele
Milan, 20132
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula
Monserrato CA, 09042
Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo
Monza (MB), 20900
Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi
Naples, 80131
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano (TO), 10043
Istituto Oncologico Veneto IRCCS
Padova, 35128
Azienda Unità Sanitaria Locale della Romagna Presidio ospedaliero di Ravenna
Ravenna, 48100
Azienda Ospedaliera Policlinico Umberto I
Roma, 00161
Policlinico Universitario Agostino Gemelli
Roma, 00168
Germany15 sites
Evangelische Lungenklinik
Berlin, 13125
Charite Universitätsmedizin Berlin, Charité Campus Virchow-Klinikum
Berlin, 13353
Universitaetsklinikum Carl Gustav Carus
Dresden, 01307
Universitätsklinikum Essen
Essen, 45147
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730
Universitätsklinikum Frankfurt/Main
Frankfurt am Main, 60590
Asklepios - Fachkliniken München-Gauting
Gauting, 82130
LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
Studiengesellschaft Hämato Onkologie Hamburg Prof Laack und Partner
Hamburg, 20251
Universitaetsklinikum Heidelberg
Heidelberg, 69126
Klinikverbund Allgäu
Immenstadt im Allgäu, 87509
Universitatsklinikum Koln
Köln, 50937
Pneumologisch/onkologisch/internistisches Studienzentrum
Leipzig, 04357
Bethanien Krankenhaus
Moers, 47441
Pius-Hospital Oldenburg
Oldenburg, 26121
Greece12 sites
Agios Savvas Anticancer Hospital
Athens, 115 22
Henry Dunant Hospital Center
Athens, 11526
Sotiria General Hospital
Athens, 11527
General Oncology Hospital of Kifissia Agioi Anargyroi
Athens, 14564
Metropolitan Hospital
Athens, 18547
University Hospital of Heraklion
Heraklion - Crete, 71110
University Hospital of Larissa
Larissa, 41110
University Hospital of Patras
Pátrai, 26504
Theagenion Cancer Hospital
Thessaloniki, 54007
Bioclinic of Thessaloniki
Thessaloniki, 54622
Euromedica General Clinic of Thessaloniki
Thessaloniki, 54645
Agios Loukas Clinic
Thessaloniki, 55236
Spain12 sites
Complexo Hospitalario Universitario A Coruña Hospital Teresa Herrera
A Coruña, Galicia, 15006
Hospital Universitari Vall d Hebron
Barcelona, Cataluña, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, Cataluña, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Cataluña, 08041
Instituto Catalan de Oncologia Hospital Duran i Reynals
L'Hospitalet de Llobregat, Cataluña, 08907
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Canary Islands, 35016
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
Hospital Regional Universitario de Malaga
Málaga, AndalucÃ-a, 29011
Hospital Clinico Universitario de Valencia
Valencia, Valencia, 46010
South Korea11 sites
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do, 28644
National Cancer Center
Goyang-si Gyeonggi-do, 10408
Cha Bundang Medical Center, Cha University
Seongnam-si, Gyeonggi-do, 13496
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, 03080
Kangbuk Samsung Hospital
Seoul, 03181
Severance Hospital Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung medical center
Seoul, 06351
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591
Ulsan University Hospital
Ulsan, 44033
Australia10 sites
Blacktown Hospital
Blacktown, New South Wales, 2148
Chris OBrien Lifehouse
Camperdown, New South Wales, 2050
Prince Charles Hospital
Chermside, Queensland, 4032
Monash Medical Centre
Clayton, Victoria, 3168
St George Hospital
Kogarah, New South Wales, 2217
Liverpool Hospital
Liverpool, New South Wales, 2170
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
St John of God Healthcare
Subiaco, Western Australia, 6008
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Brazil10 sites
Hospital de Caridade de Ijui
Ijuí, Rio Grande do Sul, 98700-000
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90610-000
Centro de Tratamento de Tumores Botafogo
Rio de Janeiro, 22250-905
Instituto Coi
Rio de Janeiro, 22793-080
Hospital de Base de Sao Jose do Rio Preto
São José Do Rio Preto, São Paulo, 15090-000
Fundacao Antonio Prudente - Hospital A C Camargo
São Paulo, São Paulo, 01509-900
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, São Paulo, 01308-050
Beneficencia Portuguesa de Sao Paulo
São Paulo, São Paulo, 01321-001
Oncologia Rede D´Or
São Paulo, São Paulo, 04501-000
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652-900
Belgium9 sites
Institute Jules Bordet
Brussels, 1000
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, 1200
Grand Hopital de Charleroi
Charleroi, 6000
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Universitair Ziekenhuis Gent
Ghent, 9000
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000
Centre Hospitalier Universitaire de Liege
Liège, 4000
AZ Delta Campus Rumbeke
Roeselare, 8800
Algemeen Ziekenhuis Nikolaas Campus Sint Niklaas
Sint-Niklaas, 9100
Hungary9 sites
Semmelweis Egyetem
Budapest, 1083
Orszagos Koranyi Pulmonologiai Intezet
Budapest, 1121
Veszprem Megyei Tudogyogyintezet
Farkasgyepű, 8582
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula, 5700
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
Miskolc, 3529
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000
Szent Borbala Korhaz
Tatabánya, 2800
Tudogyogyintezet Torokbalint
Törökbálint, 2045
United Kingdom8 sites
Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Western General Hospital
Edinburgh, EH4 2XU
Royal Marsden Hospital
London, SW3 6JJ
Sarah Cannon Research Institute UK
London, W1G 6AD
Christie Hospital
Manchester, M20 4BX
Nottingham City Hospital
Nottingham, NG5 1PB
Churchill Hospital
Oxford, OX3 7LJ
Royal Marsden Hospital
Sutton, SM2 5PT
Canada7 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
London Health Sciences Centre
London, Ontario, N6A 5W9
Centre Hospitalier de L'Universite de Montreal Hopital Notre-Dame
Montreal, Quebec, H2X 3E4
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Sweden6 sites
Gavle Sjukhus
Gävle, 801 87
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45
Universitetssjukhuset i Linkoping
Linköping, 581 85
Skanes Universitetssjukhus
Lund, 221 85
Karolinska Universitetssjukhuset Solna
Stockholm, 171 64
Norrlands Universitetssjukhus
Umeå, 901 85
Switzerland6 sites
Universitaetsspital Basel
Basel, 4031
Inselspital Bern
Bern, 3010
Hopitaux Universitaires de Geneve
Geneva, 1205
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
Kantonsspital Winterthur
Winterthur, 8401
Universitaetsspital Zuerich
Zurich, 8091
Netherlands5 sites
Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
Amsterdam, 1066 CX
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Radboudumc
Nijmegen, 6525 GA
Erasmus Medisch Centrum
Rotterdam, 3015 GD
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Poland5 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Instytut Genetyki i Immunologii GENIM Spzoo
Lublin, 20-609
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu
Poznan, 60-569
Centrum Onkologii Instytut im Marii Sklodowskiej-Curie
Warsaw, 02-781
Dolnoslaskie Centrum Onkologii we Wroclawiu
Wroclaw, 53-413
Portugal5 sites
Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente
Lisbon, 1769-001
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality, 4464-513
Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio
Porto, 4099-001
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072
Centro Hospitalar Universitario de Sao Joao EPE - Hospital Sao Joao
Porto, 4200-319
Russia5 sites
Clinical hospital 2, Group of companies medsi
Moscow, 125284
LLC Tonus
Nizhny Novgorod, 603089
Omsk Regional Clinical Oncology Dispensary
Omsk, 644013
FSBI Scientific and Research Oncology Institute named after N N Petrov
Saint Petersburg, 197758
Saint Petersburg scientifical practical center of specialized kinds of medical care oncological
Saint Petersburg, 197758
Finland4 sites
Docrates Syopasairaala
Helsinki, 00180
Helsingin Yliopistollinen Keskussairaala
Helsinki, 00290
Oulu University Hospital
Oulu, 90220
Turku University Hospital
Turku, 20520
Taiwan4 sites
China Medical University Hospital
Taichung, 40447
Veterans General Hospital - Taichung
Taichung, 40705
National Cheng Kung University Hospital
Tainan, 70403
National Taiwan University Hospital
Taipei, 10002
Denmark3 sites
Herlev og Gentofte Hospital
Herlev, 2730
Rigshospitalet
København, 2100
Odense Universitetshospital
Odense C, 5000
About this study
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
A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation
- Being tested
- AMG 510, Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 510Drug
21 day cycles
DocetaxelDrug
21 day cycles
| Study group | Role | What they receive |
|---|---|---|
| AMG 510 | Experimental | Not described Receives: Drug: AMG 510 |
| Docetaxel | Active comparator | Not described Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start4 Jun 2020
- Primary completion2 Aug 2022
- Study completion24 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for KRAS p, G12c Mutated /Advanced Metastatic NSCLCStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303780
- Sponsor's protocol ID
- 20190009
- Other IDs
- 2023-508214-42-00, 2023
- Status last verified
- Jun 2026
- First submitted
- 5 Mar 2020
- Last updated
- 22 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
- Expanded access
- Available
Publications
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.
PubMed 39303400Skoulidis 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.
PubMed 39846981Skoulidis 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.
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