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

NCT ID: NCT04303780

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 345 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-04
• Study Completion Date: 2026-02-25

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

Conditions

KRAS p, G12c Mutated /Advanced Metastatic NSCLC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AMG 510

Group Type: EXPERIMENTAL

AMG 510

Intervention Type: DRUG

21 day cycles

Docetaxel

Group Type: ACTIVE_COMPARATOR

Docetaxel

Intervention Type: DRUG

21 day cycles

Interventions

AMG 510

21 day cycles

Intervention Type: DRUG

Docetaxel

21 day cycles

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Pacific Cancer Medical Center Inc

Anaheim, California, United States

City of Hope National Medical Center

Duarte, California, United States

Pacific Shores Medical Group Long Beach

Long Beach, California, United States

University of California Los Angeles

Los Angeles, California, United States

University of California Los Angeles

Los Angeles, California, United States

University of California at Davis Medical Center

Sacramento, California, United States

Ridley Tree Cancer Center

Santa Barbara, California, United States

University of California San Francisco Mission Hall

Stanford, California, United States

Harbor University of California Los Angeles Medical Center

Torrance, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Danbury Hospital

Norwalk, Connecticut, United States

Medical Oncology Hematology Consultants Helen F Graham Cancer Center

Newark, Delaware, United States

Washington Cancer Institute at MedStar Washington Hospital

Washington D.C., District of Columbia, United States

Florida Cancer Specialists - Fort Myers

Fort Myers, Florida, United States

Memorial Regional Hospital

Hollywood, Florida, United States

Florida Cancer Specialists Research North

St. Petersburg, Florida, United States

Florida Cancer Specialists Research Panhandle

Tallahassee, Florida, United States

Emory University

Atlanta, Georgia, United States

Northside Hospital, Incorporated

Atlanta, Georgia, United States

Affiliated Oncologists, LLC

North Chicago, Illinois, United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

Willis Knighton Cancer Center

Shreveport, Louisiana, United States

Maryland Oncology Hematology PA

Clinton, Maryland, United States

New York Cancer and Blood Specialists

Lowell, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Center for Oncology Clinical Trials

Grand Rapids, Michigan, United States

Minnesota Oncology Hematology PA

Minneapolis, Minnesota, United States

HCA Midwest Health Kansas City

Kansas City, Missouri, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Summit Medical Group

Florham Park, New Jersey, United States

New York Oncology Hematology, PC

Albany, New York, United States

United States Oncology Regulatory Affairs Corporate Office

Albany, New York, United States

Northwell Health Monter Cancer Center

Lake Success, New York, United States

Montefiore Einstein Center for Cancer Care

The Bronx, New York, United States

James J Peters VA Medical Center

The Bronx, New York, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Oncology Hematology Care Inc

Cincinnati, Ohio, United States

Northwest Cancer Specialists - Vancouver

Portland, Oregon, United States

Charleston Oncology

Charleston, South Carolina, United States

Saint Francis Hospital, Inc

Greenville, South Carolina, United States

Tennessee Oncology PLLC

Chattanooga, Tennessee, United States

Tennessee Cancer Specialists

Knoxville, Tennessee, United States

Tennessee Oncology

Nashville, Tennessee, United States

Texas Oncology-Bedford

Bedford, Texas, United States

Texas Oncology Baylor

Dallas, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

The Center for Cancer and Blood Disorders

Fort Worth, Texas, United States

Valley Cancer Associates

Harlingen, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

US Oncology Research Investigational Products Center

Irving, Texas, United States

Hope Cancer Center

Tyler, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Blacktown Hospital

Blacktown, New South Wales, Australia

Chris OBrien Lifehouse

Camperdown, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Prince Charles Hospital

Chermside, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Monash Medical Centre

Clayton, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

St John of God Healthcare

Subiaco, Western Australia, Australia

Institute Jules Bordet

Brussels, , Belgium

Universite Catholique de Louvain Cliniques Universitaires Saint Luc

Brussels, , Belgium

Grand Hopital de Charleroi

Charleroi, , Belgium

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, , Belgium

Centre Hospitalier Universitaire de Liege

Liège, , Belgium

AZ Delta Campus Rumbeke

Roeselare, , Belgium

Algemeen Ziekenhuis Nikolaas Campus Sint Niklaas

Sint-Niklaas, , Belgium

Hospital de Caridade de Ijui

Ijuí, Rio Grande do Sul, Brazil

Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Sociedade Beneficente de Senhoras Hospital Sirio Libanes

São Paulo, São Paulo, Brazil

Beneficencia Portuguesa de Sao Paulo

São Paulo, São Paulo, Brazil

Oncologia Rede D´Or

São Paulo, São Paulo, Brazil

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Hospital de Base de Sao Jose do Rio Preto

São José Do Rio Preto, São Paulo, Brazil

Fundacao Antonio Prudente - Hospital A C Camargo

São Paulo, São Paulo, Brazil

Centro de Tratamento de Tumores Botafogo

Rio de Janeiro, , Brazil

Instituto Coi

Rio de Janeiro, , Brazil

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Centre Hospitalier de L'Universite de Montreal Hopital Notre-Dame

Montreal, Quebec, Canada

Herlev og Gentofte Hospital

Herlev, , Denmark

Rigshospitalet

København, , Denmark

Odense Universitetshospital

Odense C, , Denmark

Docrates Syopasairaala

Helsinki, , Finland

Helsingin Yliopistollinen Keskussairaala

Helsinki, , Finland

Oulu University Hospital

Oulu, , Finland

Turku University Hospital

Turku, , Finland

Centre Hospitalier Regional Universitaire - Hopital Morvan

Brest, , France

Centre Hospitalier Intercommunal de Créteil

Créteil, , France

Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

Grenoble, , France

Centre Hospitalier Universitaire Régional de Lille - Hôpital Albert Calmette

Lille, , France

Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren

Limoges, , France

Centre Leon Berard

Lyon, , France

Centre Hospitalier Universitaire Nord

Marseille, , France

Institut Curie

Paris, , France

Hopital Cochin

Paris, , France

Hopital Bichat Claude Bernard

Paris, , France

Hôpital Tenon

Paris, , France

Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

Pessac, , France

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

Rennes, , France

Centre Hospitalier de Nantes - Hôpital Nord LaÃ"nnec

Saint-Herblain, , France

Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

Strasbourg, , France

Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

Toulouse, , France

Gustave Roussy

Villejuif, , France

Evangelische Lungenklinik

Berlin, , Germany

Charite Universitätsmedizin Berlin, Charité Campus Virchow-Klinikum

Berlin, , Germany

Universitaetsklinikum Carl Gustav Carus

Dresden, , Germany

Universitätsklinikum Essen

Essen, , Germany

Klinikum Esslingen GmbH

Esslingen am Neckar, , Germany

Universitätsklinikum Frankfurt/Main

Frankfurt am Main, , Germany

Asklepios - Fachkliniken München-Gauting

Gauting, , Germany

LungenClinic Grosshansdorf GmbH

Großhansdorf, , Germany

Studiengesellschaft Hämato Onkologie Hamburg Prof Laack und Partner

Hamburg, , Germany

Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Klinikverbund Allgäu

Immenstadt im Allgäu, , Germany

Universitatsklinikum Koln

Köln, , Germany

Pneumologisch/onkologisch/internistisches Studienzentrum

Leipzig, , Germany

Bethanien Krankenhaus

Moers, , Germany

Pius-Hospital Oldenburg

Oldenburg, , Germany

Agios Savvas Anticancer Hospital

Athens, , Greece

Henry Dunant Hospital Center

Athens, , Greece

Sotiria General Hospital

Athens, , Greece

General Oncology Hospital of Kifissia Agioi Anargyroi

Athens, , Greece

Metropolitan Hospital

Athens, , Greece

University Hospital of Heraklion

Heraklion - Crete, , Greece

University Hospital of Larissa

Larissa, , Greece

University Hospital of Patras

Pátrai, , Greece

Theagenion Cancer Hospital

Thessaloniki, , Greece

Bioclinic of Thessaloniki

Thessaloniki, , Greece

Euromedica General Clinic of Thessaloniki

Thessaloniki, , Greece

Agios Loukas Clinic

Thessaloniki, , Greece

Semmelweis Egyetem

Budapest, , Hungary

Orszagos Koranyi Pulmonologiai Intezet

Budapest, , Hungary

Veszprem Megyei Tudogyogyintezet

Farkasgyepű, , Hungary

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, , Hungary

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvár, , Hungary

Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

Miskolc, , Hungary

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, , Hungary

Szent Borbala Korhaz

Tatabánya, , Hungary

Tudogyogyintezet Torokbalint

Törökbálint, , Hungary

Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati

Avellino, , Italy

IRCCS Istituto Tumori Giovanni Paolo II

Bari, , Italy

Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi

Bologna, , Italy

Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico

Catania, , Italy

Azienda Ospedaliero Universitaria Careggi

Florence, , Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, , Italy

IRCCS Ospedale San Raffaele

Milan, , Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula

Monserrato CA, , Italy

Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo

Monza (MB), , Italy

Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi

Napoli, , Italy

Azienda Ospedaliera Universitaria San Luigi Gonzaga

Orbassano (TO), , Italy

Istituto Oncologico Veneto IRCCS

Padua, , Italy

Azienda Unità Sanitaria Locale della Romagna Presidio ospedaliero di Ravenna

Ravenna, , Italy

Azienda Ospedaliera Policlinico Umberto I

Roma, , Italy

Policlinico Universitario Agostino Gemelli

Roma, , Italy

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Chiba Cancer Center

Chiba, Chiba, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi, Fukuoka, Japan

Chugoku Central Hospital of Japan Mutual Aid Association of Public School Teachers

Fukuyama-shi, Hiroshima, Japan

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Hyogo Cancer Center

Akashi-shi, Hyōgo, Japan

National Hospital Organization Himeji Medical Center

Himeji-shi, Hyōgo, Japan

Itami City Hospital

Itami-shi, Hyōgo, Japan

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

St Marianna University School of Medicine Hospital

Kawasaki-shi, Kanagawa, Japan

Kitasato University Hospital

Sagamihara-shi, Kanagawa, Japan

Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Kyoto University Hospital

Kyoto, Kyoto, Japan

Miyagi Cancer Center

Natori-shi, Miyagi, Japan

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

Osaka Habikino Medical Center

Habikino-shi, Osaka, Japan

Kansai Medical University Hospital

Hirakata-shi, Osaka, Japan

Osaka City General Hospital

Osaka, Osaka, Japan

Osaka International Cancer Institute

Osaka, Osaka, Japan

Kindai University Hospital

Osakasayama-shi, Osaka, Japan

National Hospital Organization Kinki-chuo Chest Medical Center

Sakai-shi, Osaka, Japan

Saga-ken Medical Centre Koseikan

Saga, Saga-ken, Japan

Saitama Cancer Center

Kitaadachi-gun, Saitama, Japan

Shiga University of Medical Science Hospital

Ōtsu, Shiga, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, Japan

Tottori University Hospital

Yonago-shi, Tottori, Japan

Wakayama Medical University Hospital

Wakayama, Wakayama, Japan

National Hospital Organization Iwakuni Clinical Center

Iwakuni-shi, Yamaguchi, Japan

National Hospital Organization Yamaguchi Ube Medical Center

Ube-shi, Yamaguchi, Japan

Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis

Amsterdam, , Netherlands

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

Radboudumc

Nijmegen, , Netherlands

Erasmus Medisch Centrum

Rotterdam, , Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, , Netherlands

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Instytut Genetyki i Immunologii GENIM Spzoo

Lublin, , Poland

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu

Poznan, , Poland

Centrum Onkologii Instytut im Marii Sklodowskiej-Curie

Warsaw, , Poland

Dolnoslaskie Centrum Onkologii we Wroclawiu

Wroclaw, , Poland

Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente

Lisbon, , Portugal

Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

Matosinhos Municipality, , Portugal

Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio

Porto, , Portugal

Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

Porto, , Portugal

Centro Hospitalar Universitario de Sao Joao EPE - Hospital Sao Joao

Porto, , Portugal

Clinical hospital 2, Group of companies medsi

Moscow, , Russia

LLC Tonus

Nizhny Novgorod, , Russia

Omsk Regional Clinical Oncology Dispensary

Omsk, , Russia

FSBI Scientific and Research Oncology Institute named after N N Petrov

Saint Petersburg, , Russia

Saint Petersburg scientifical practical center of specialized kinds of medical care oncological

Saint Petersburg, , Russia

Chungbuk National University Hospital

Cheongju-si, Chungcheongbuk-do, , South Korea

National Cancer Center

Goyang-si Gyeonggi-do, , South Korea

Cha Bundang Medical Center, Cha University

Seongnam-si, Gyeonggi-do, , South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung medical center

Seoul, , South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, , South Korea

Ulsan University Hospital

Ulsan, , South Korea

Hospital Regional Universitario de Malaga

Málaga, AndalucÃ-a, Spain

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, Canary Islands, Spain

Hospital Universitari Vall d Hebron

Barcelona, Cataluña, Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, Cataluña, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Cataluña, Spain

Instituto Catalan de Oncologia Hospital Duran i Reynals

L'Hospitalet de Llobregat, Cataluña, Spain

Complexo Hospitalario Universitario A Coruña Hospital Teresa Herrera

A Coruña, Galicia, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Hospital Clinico Universitario de Valencia

Valencia, Valencia, Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Gavle Sjukhus

Gävle, , Sweden

Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Universitetssjukhuset i Linkoping

Linköping, , Sweden

Skanes Universitetssjukhus

Lund, , Sweden

Karolinska Universitetssjukhuset Solna

Stockholm, , Sweden

Norrlands Universitetssjukhus

Umeå, , Sweden

Universitaetsspital Basel

Basel, , Switzerland

Inselspital Bern

Bern, , Switzerland

Hopitaux Universitaires de Geneve

Geneva, , Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Kantonsspital Winterthur

Winterthur, , Switzerland

Universitaetsspital Zuerich

Zurich, , Switzerland

China Medical University Hospital

Taichung, , Taiwan

Veterans General Hospital - Taichung

Taichung, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust

Cambridge, , United Kingdom

Western General Hospital

Edinburgh, , United Kingdom

Royal Marsden Hospital

London, , United Kingdom

Sarah Cannon Research Institute UK

London, , United Kingdom

Christie Hospital

Manchester, , United Kingdom

Nottingham City Hospital

Nottingham, , United Kingdom

Churchill Hospital

Oxford, , United Kingdom

Royal Marsden Hospital

Sutton, , United Kingdom

Countries

United States; Australia; Belgium; Brazil; Canada; Denmark; Finland; France; Germany; Greece; Hungary; Italy; Japan; Netherlands; Poland; Portugal; Russia; South Korea; Spain; Sweden; Switzerland; Taiwan; United Kingdom

References

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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.

Reference Type: DERIVED

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

2023-508214-42-00

Identifier Type: OTHER

Identifier Source: secondary_id

20190009

Identifier Type: -

Identifier Source: org_study_id