KRAS p, G12c Mutated /Advanced Metastatic NSCLC Clinical Trial
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
| Verified date | March 2024 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation
| Status | Active, not recruiting |
| Enrollment | 345 |
| Est. completion date | April 27, 2026 |
| Est. primary completion date | August 2, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Blacktown Hospital | Blacktown | New South Wales |
| Australia | Chris OBrien Lifehouse | Camperdown | New South Wales |
| Australia | Prince Charles Hospital | Chermside | Queensland |
| Australia | Monash Medical Centre | Clayton | Victoria |
| Australia | St George Hospital | Kogarah | New South Wales |
| Australia | Liverpool Hospital | Liverpool | New South Wales |
| Australia | Peter MacCallum Cancer Centre | Melbourne | Victoria |
| Australia | St John of God Healthcare | Subiaco | Western Australia |
| Australia | The Queen Elizabeth Hospital | Woodville South | South Australia |
| Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
| Belgium | Institute Jules Bordet | Brussels | |
| Belgium | Universite Catholique de Louvain Cliniques Universitaires Saint Luc | Bruxelles | |
| Belgium | Grand Hopital de Charleroi | Charleroi | |
| Belgium | Universitair Ziekenhuis Antwerpen | Edegem | |
| Belgium | Universitair Ziekenhuis Gent | Gent | |
| Belgium | Universitair Ziekenhuis Leuven - Campus Gasthuisberg | Leuven | |
| Belgium | Centre Hospitalier Universitaire de Liege | Liege | |
| Belgium | AZ Delta Campus Rumbeke | Roeselare | |
| Belgium | Algemeen Ziekenhuis Nikolaas Campus Sint Niklaas | Sint-Niklaas | |
| Brazil | Hospital de Caridade de Ijui | Ijui | Rio Grande Do Sul |
| Brazil | Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul | Porto Alegre | Rio Grande Do Sul |
| Brazil | Centro de Tratamento de Tumores Botafogo | Rio de Janeiro | |
| Brazil | Instituto Coi | Rio de Janeiro | |
| 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 | |
| Brazil | Beneficencia Portuguesa de Sao Paulo | Sao Paulo | São Paulo |
| Brazil | Hospital Israelita Albert Einstein | Sao Paulo | São Paulo |
| Brazil | Oncologia Rede D´Or | Sao Paulo | São Paulo |
| Brazil | Sociedade Beneficente de Senhoras Hospital Sirio Libanes | Sao Paulo | São Paulo |
| Canada | 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 | Centre Hospitalier de L'Universite de Montreal Hopital Notre-Dame | Montreal | Quebec |
| Canada | The Ottawa Hospital Cancer Centre | Ottawa | Ontario |
| Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
| Denmark | Herlev og Gentofte Hospital | Herlev | |
| Denmark | Rigshospitalet | København | |
| Denmark | Odense Universitetshospital | Odense C | |
| Finland | Docrates Syopasairaala | Helsinki | |
| Finland | Helsingin Yliopistollinen Keskussairaala | Helsinki | |
| Finland | Oulu University Hospital | Oulu | |
| Finland | Turku University Hospital | Turku | |
| France | 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 Cedex | |
| France | Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren | Limoges Cedex | |
| France | Centre Leon Berard | Lyon | |
| France | Centre Hospitalier Universitaire Nord | Marseille Cedex 20 | |
| France | Hopital Bichat Claude Bernard | Paris | |
| France | Hopital Cochin | Paris | |
| France | Institut Curie | Paris | |
| France | Hôpital Tenon | Paris Cedex 20 | |
| France | Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque | Pessac Cedex | |
| France | Centre Hospitalier Lyon Sud | Pierre-Benite cedex | |
| 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 cedex | |
| France | Centre Hospitalier Universitaire de Toulouse - Hopital Larrey | Toulouse Cedex 9 | |
| France | Gustave Roussy | Villejuif | |
| Germany | Charite Universitätsmedizin Berlin, Charité Campus Virchow-Klinikum | Berlin | |
| Germany | Evangelische Lungenklinik | 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 | |
| Germany | Universitatsklinikum Koln | Köln | |
| Germany | Pneumologisch/onkologisch/internistisches Studienzentrum | Leipzig | |
| Germany | Bethanien Krankenhaus | Moers | |
| Germany | Pius-Hospital Oldenburg | Oldenburg | |
| Greece | Agios Savvas Anticancer Hospital | Athens | |
| Greece | General Oncology Hospital of Kifissia Agioi Anargyroi | Athens | |
| Greece | Henry Dunant Hospital Center | Athens | |
| Greece | Metropolitan Hospital | Athens | |
| Greece | Sotiria General Hospital | Athens | |
| Greece | University Hospital of Heraklion | Heraklion - Crete | |
| Greece | University Hospital of Larissa | Larissa | |
| Greece | University Hospital of Patras | Patra | |
| Greece | Agios Loukas Clinic | Thessaloniki | |
| Greece | Bioclinic of Thessaloniki | Thessaloniki | |
| Greece | Euromedica General Clinic of Thessaloniki | Thessaloniki | |
| Greece | Theagenion Cancer Hospital | Thessaloniki | |
| Hungary | Orszagos Koranyi Pulmonologiai Intezet | Budapest | |
| Hungary | Semmelweis Egyetem | Budapest | |
| Hungary | Veszprem Megyei Tudogyogyintezet | Farkasgyepu | |
| Hungary | Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz | Gyula | |
| Hungary | Somogy Megyei Kaposi Mor Oktato Korhaz | Kaposvar | |
| Hungary | Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz | Miskolc | |
| Hungary | Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Szekesfehervar | |
| Hungary | Szent Borbala Korhaz | Tatabanya | |
| Hungary | Tudogyogyintezet Torokbalint | Torokbalint | |
| Italy | 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 | Firenze | |
| Italy | Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milano | |
| Italy | Fondazione IRCCS Istituto Nazionale dei Tumori | Milano | |
| Italy | IRCCS Ospedale San Raffaele | Milano | |
| 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 | Padova | |
| 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 | |
| Japan | Hyogo Cancer Center | Akashi-shi | Hyogo |
| Japan | Juntendo University Hospital | Bunkyo-ku | Tokyo |
| Japan | Chiba Cancer Center | Chiba-shi | Chiba |
| Japan | National Cancer Center Hospital | Chuo-ku | Tokyo |
| Japan | Kyushu University Hospital | Fukuoka-shi | Fukuoka |
| Japan | National Hospital Organization Kyushu Cancer Center | Fukuoka-shi | Fukuoka |
| Japan | Chugoku Central Hospital of Japan Mutual Aid Association of Public School Teachers | Fukuyama-shi | Hiroshima |
| Japan | Osaka Habikino Medical Center | Habikino-shi | Osaka |
| Japan | National Hospital Organization Himeji Medical Center | Himeji-shi | Hyogo |
| Japan | Kansai Medical University Hospital | Hirakata-shi | Osaka |
| Japan | Hiroshima University Hospital | Hiroshima-shi | Hiroshima |
| Japan | Itami City Hospital | Itami-shi | Hyogo |
| Japan | National Hospital Organization Iwakuni Clinical Center | Iwakuni-shi | Yamaguchi |
| Japan | Kanazawa University Hospital | Kanazawa-shi | Ishikawa |
| Japan | National Cancer Center Hospital East | Kashiwa-shi | Chiba |
| Japan | St Marianna University School of Medicine Hospital | Kawasaki-shi | Kanagawa |
| Japan | Saitama Cancer Center | Kitaadachi-gun | Saitama |
| Japan | Hospital of the University of Occupational and Environmental Health | Kitakyushu-shi | Fukuoka |
| Japan | Kobe City Medical Center General Hospital | Kobe-shi | Hyogo |
| Japan | Cancer Institute Hospital of Japanese Foundation for Cancer Research | Koto-ku | Tokyo |
| Japan | Kyoto University Hospital | Kyoto-shi | Kyoto |
| Japan | National Hospital Organization Shikoku Cancer Center | Matsuyama-shi | Ehime |
| Japan | Aichi Cancer Center Hospital | Nagoya-shi | Aichi |
| Japan | Nagoya University Hospital | Nagoya-shi | Aichi |
| Japan | Miyagi Cancer Center | Natori-shi | Miyagi |
| Japan | Niigata Cancer Center Hospital | Niigata-shi | Niigata |
| Japan | Okayama University Hospital | Okayama-shi | Okayama |
| Japan | Osaka City General Hospital | Osaka-shi | Osaka |
| Japan | Osaka International Cancer Institute | Osaka-shi | Osaka |
| Japan | Kindai University Hospital | Osakasayama-shi | Osaka |
| Japan | Shiga University of Medical Science Hospital | Otsu-shi | Shiga |
| Japan | Saga-ken Medical Centre Koseikan | Saga-shi | Saga |
| Japan | Kitasato University Hospital | Sagamihara-shi | Kanagawa |
| Japan | National Hospital Organization Kinki-chuo Chest Medical Center | Sakai-shi | Osaka |
| Japan | National Hospital Organization Hokkaido Cancer Center | Sapporo-shi | Hokkaido |
| Japan | Sendai Kousei Hospital | Sendai-shi | Miyagi |
| Japan | National Hospital Organization Yamaguchi Ube Medical Center | Ube-shi | Yamaguchi |
| Japan | Wakayama Medical University Hospital | Wakayama-shi | Wakayama |
| Japan | Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center | Yokohama-shi | Kanagawa |
| Japan | Tottori University Hospital | Yonago-shi | Tottori |
| Korea, Republic of | Chungbuk National University Hospital | Cheongju-si, Chungcheongbuk-do | |
| Korea, Republic of | National Cancer Center | Goyang-si Gyeonggi-do | |
| Korea, Republic of | Cha Bundang Medical Center, Cha University | Seongnam-si, Gyeonggi-do | |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si, Gyeonggi-do | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Kangbuk Samsung Hospital | Seoul | |
| Korea, Republic of | Samsung medical center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Severance Hospital Yonsei University Health System | Seoul | |
| Korea, Republic of | The Catholic University of Korea Seoul St Marys Hospital | Seoul | |
| Korea, Republic of | Ulsan University Hospital | Ulsan | |
| Netherlands | 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 | |
| Poland | 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 | Warszawa | |
| Poland | Dolnoslaskie Centrum Onkologii we Wroclawiu | Wroclaw | |
| Portugal | Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente | Lisboa | |
| Portugal | Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano | Matosinhos | |
| Portugal | Centro Hospitalar Universitario de Sao Joao EPE - Hospital Sao Joao | Porto | |
| Portugal | Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio | Porto | |
| Portugal | Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE | Porto | |
| Russian Federation | Clinical hospital 2, Group of companies medsi | Moscow | |
| Russian Federation | LLC Tonus | Nizhniy Novgorod | |
| Russian Federation | Omsk Regional Clinical Oncology Dispensary | Omsk | |
| Russian Federation | FSBI Scientific and Research Oncology Institute named after N N Petrov | Saint-Petersburg | |
| Russian Federation | Saint Petersburg scientifical practical center of specialized kinds of medical care oncological | Saint-Petersburg | |
| Spain | Complexo Hospitalario Universitario A Coruña Hospital Teresa Herrera | A Coruña | Galicia |
| Spain | Hospital Clinic i Provincial de Barcelona | Barcelona | Cataluña |
| Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | Cataluña |
| Spain | Hospital Universitari Vall d Hebron | Barcelona | Cataluña |
| Spain | Instituto Catalan de Oncologia Hospital Duran i Reynals | Hospitalet de Llobregat | Cataluña |
| Spain | Hospital Universitario Insular de Gran Canaria | Las Palmas de Gran Canaria | Canarias |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Universitario Ramon y Cajal | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid |
| Spain | Hospital Regional Universitario de Malaga | Malaga | AndalucÃ-a |
| Spain | Hospital Clinico Universitario de Valencia | Valencia | Comunidad Valenciana |
| Sweden | Gavle Sjukhus | Gavle | |
| Sweden | Sahlgrenska Universitetssjukhuset | Goteborg | |
| Sweden | Universitetssjukhuset i Linkoping | Linkoping | |
| Sweden | Skanes Universitetssjukhus | Lund | |
| Sweden | Karolinska Universitetssjukhuset Solna | Stockholm | |
| Sweden | Norrlands Universitetssjukhus | Umea | |
| Switzerland | Universitaetsspital Basel | Basel | |
| Switzerland | Inselspital Bern | Bern | |
| Switzerland | Hopitaux Universitaires de Geneve | Geneve | |
| Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne | |
| Switzerland | Kantonsspital Winterthur | Winterthur | |
| Switzerland | Universitaetsspital Zuerich | Zurich | |
| Taiwan | China Medical University Hospital | Taichung | |
| Taiwan | Veterans General Hospital - Taichung | Taichung | |
| Taiwan | National Cheng Kung University Hospital | Tainan | |
| Taiwan | National Taiwan University Hospital | Taipei | |
| United Kingdom | 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 States | New York Oncology Hematology, PC | Albany | New York |
| United States | United States Oncology Regulatory Affairs Corporate Office | Albany | New York |
| United States | Pacific Cancer Medical Center Inc | Anaheim | California |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | Emory University | Atlanta | Georgia |
| United States | Northside Hospital, Incorporated | Atlanta | Georgia |
| United States | Texas Oncology-Bedford | Bedford | Texas |
| United States | James J Peters VA Medical Center | Bronx | New York |
| United States | Montefiore Einstein Center for Cancer Care | Bronx | New York |
| United States | Charleston Oncology | Charleston | South Carolina |
| United States | Tennessee Oncology PLLC | Chattanooga | Tennessee |
| United States | Oncology Hematology Care Inc | Cincinnati | Ohio |
| United States | Maryland Oncology Hematology PA | Clinton | Maryland |
| United States | Texas Oncology Baylor | Dallas | Texas |
| United States | UT Southwestern Medical Center | Dallas | Texas |
| United States | Rocky Mountain Cancer Centers | Denver | Colorado |
| United States | City of Hope National Medical Center | Duarte | California |
| United States | Virginia Cancer Specialists, PC | Fairfax | Virginia |
| United States | Summit Medical Group | Florham Park | New Jersey |
| United States | Florida Cancer Specialists - Fort Myers | Fort Myers | Florida |
| United States | Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana |
| United States | The Center for Cancer and Blood Disorders | Fort Worth | Texas |
| United States | Center for Oncology Clinical Trials | Grand Rapids | Michigan |
| United States | Saint Francis Hospital, Inc | Greenville | South Carolina |
| United States | Valley Cancer Associates | Harlingen | Texas |
| United States | Memorial Regional Hospital | Hollywood | Florida |
| United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
| United States | US Oncology Research Investigational Products Center | Irving | Texas |
| United States | HCA Midwest Health Kansas City | Kansas City | Missouri |
| United States | Tennessee Cancer Specialists | Knoxville | Tennessee |
| United States | Northwell Health Monter Cancer Center | Lake Success | New York |
| United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
| 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 | New York Cancer and Blood Specialists | Lowell | Massachusetts |
| United States | Minnesota Oncology Hematology PA | Minneapolis | Minnesota |
| United States | Intermountain Medical Center | Murray | Utah |
| United States | Tennessee Oncology | Nashville | Tennessee |
| United States | Medical Oncology Hematology Consultants Helen F Graham Cancer Center | Newark | Delaware |
| United States | Virginia Oncology Associates | Norfolk | Virginia |
| United States | Affiliated Oncologists, LLC | North Chicago | Illinois |
| United States | Danbury Hospital | Norwalk | Connecticut |
| United States | Northwest Cancer Specialists - Vancouver | Portland | Oregon |
| United States | University of California at Davis Medical Center | Sacramento | California |
| United States | Florida Cancer Specialists Research North | Saint Petersburg | Florida |
| United States | Ridley Tree Cancer Center | Santa Barbara | California |
| United States | Willis Knighton Cancer Center | Shreveport | Louisiana |
| United States | University of California San Francisco Mission Hall | Stanford | California |
| United States | Florida Cancer Specialists Research Panhandle | Tallahassee | Florida |
| United States | Harbor University of California Los Angeles Medical Center | Torrance | California |
| United States | Hope Cancer Center | Tyler | Texas |
| United States | Washington Cancer Institute at MedStar Washington Hospital | Washington | District of Columbia |
| United States | Wake Forest Baptist Health | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Australia, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Netherlands, Poland, Portugal, Russian Federation, Spain, Sweden, Switzerland, Taiwan, United Kingdom,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |