Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
Sponsor
Amgen (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04303780
Collaborator
(none)
345
274
2
70.7
1.3
0
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
345 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Jun 4, 2020
Actual Primary Completion Date
:
Aug 2, 2022
Anticipated Study Completion Date
:
Apr 27, 2026
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AMG 510
|
Drug: AMG 510
21 day cycles
|
| Active Comparator: Docetaxel
|
Drug: Docetaxel
21 day cycles
|
Outcome Measures
Primary Outcome Measures
- Progression-free survival (PFS) [Baseline to approximately 6 years]
Defined as time from randomization until disease progression or death from any cause, whichever occurs first
Secondary Outcome Measures
- Overall Survival (OS) [Baseline to approximately 6 years]
Defined as time from randomization to death by any cause
- Objective Response Rate (ORR) [Baseline to approximately 6 years]
Defined as complete response (CR ) + partial response (PR)
- Patient Reported Outcomes (PRO) [Baseline to week 12]
To be assessed by Patient-reported symptoms from selected PRO-Common Terminology Criteria for Adverse Events questions and GP5 of Functional Assessment of Cancer Therapy Tool General form (FACT-G)
- Quality of Life Assessment [Baseline to week 12]
To be as assessed by: European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 13 (EORTC QLQ-LC13) and European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ C30)
- Duration of response (DOR) [Baseline to approximately 6 years]
Defined as time from first evidence of PR or CR to disease progression or death due to any cause, whichever occurs first.
- Time to response (TTR) [Baseline to approximately 6 years]
Defined as time from randomization to first evidence of PR or CR
- Disease control rate (DCR) [Baseline to approximately 6 years]
Defined as rate of confirmed objective response (CR or PR) + stable disease (SD) per Response Evaluation Criteria in Solid Tumors version (RECIST) v1.1 of at least 6 weeks
- Number of subjects with Clinically significant changes in vital signs [Approximately 1 year]
- Number of subjects with treatment-emergent adverse events [Estimated up to approximately 6 years]
- Number of subjects with Clinically significant changes in Laboratory tests [Estimated up to approximately 1 year]
- Number of Subjects with treatment-related adverse events [Estimated up to 6 years]
- Maximum plasma concentration (Cmax) [Estimated up to 4 months]
To characterize the pharmacokinetics (PK) of AMG 510
- Area under the plasma concentration-time curve (AUC) [Estimated up to 4 months]
To characterize the pharmacokinetics (PK) of AMG 510
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pacific Cancer Medical Center Inc | Anaheim | California | United States | 92801 |
| 2 | City of Hope National Medical Center | Duarte | California | United States | 91010 |
| 3 | Pacific Shores Medical Group Long Beach | Long Beach | California | United States | 90813 |
| 4 | University of California Los Angeles | Los Angeles | California | United States | 90095-1772 |
| 5 | University of California Los Angeles | Los Angeles | California | United States | 90095 |
| 6 | University of California at Davis Medical Center | Sacramento | California | United States | 95817 |
| 7 | Ridley Tree Cancer Center | Santa Barbara | California | United States | 93105 |
| 8 | University of California San Francisco Mission Hall | Stanford | California | United States | 94305 |
| 9 | Harbor University of California Los Angeles Medical Center | Torrance | California | United States | 90502 |
| 10 | Rocky Mountain Cancer Centers | Denver | Colorado | United States | 80218 |
| 11 | Danbury Hospital | Norwalk | Connecticut | United States | 06856 |
| 12 | Medical Oncology Hematology Consultants Helen F Graham Cancer Center | Newark | Delaware | United States | 19713 |
| 13 | Washington Cancer Institute at MedStar Washington Hospital | Washington | District of Columbia | United States | 20010 |
| 14 | Florida Cancer Specialists - Fort Myers | Fort Myers | Florida | United States | 33901 |
| 15 | Memorial Regional Hospital | Hollywood | Florida | United States | 33021 |
| 16 | Florida Cancer Specialists Research North | Saint Petersburg | Florida | United States | 33705 |
| 17 | Florida Cancer Specialists Research Panhandle | Tallahassee | Florida | United States | 32308 |
| 18 | Emory University | Atlanta | Georgia | United States | 30332 |
| 19 | Northside Hospital, Incorporated | Atlanta | Georgia | United States | 30341 |
| 20 | Affiliated Oncologists, LLC | North Chicago | Illinois | United States | 60064 |
| 21 | Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | United States | 46804 |
| 22 | Willis Knighton Cancer Center | Shreveport | Louisiana | United States | 71103 |
| 23 | Maryland Oncology Hematology PA | Clinton | Maryland | United States | 20735 |
| 24 | New York Cancer and Blood Specialists | Lowell | Massachusetts | United States | 01854 |
| 25 | University of Michigan | Ann Arbor | Michigan | United States | 48109-1274 |
| 26 | Center for Oncology Clinical Trials | Grand Rapids | Michigan | United States | 49503 |
| 27 | Minnesota Oncology Hematology PA | Minneapolis | Minnesota | United States | 55404 |
| 28 | HCA Midwest Health Kansas City | Kansas City | Missouri | United States | 64132 |
| 29 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89169 |
| 30 | Summit Medical Group | Florham Park | New Jersey | United States | 07932 |
| 31 | New York Oncology Hematology, PC | Albany | New York | United States | 12208 |
| 32 | United States Oncology Regulatory Affairs Corporate Office | Albany | New York | United States | 12208 |
| 33 | Montefiore Einstein Center for Cancer Care | Bronx | New York | United States | 10461 |
| 34 | James J Peters VA Medical Center | Bronx | New York | United States | 10468 |
| 35 | Northwell Health Monter Cancer Center | Lake Success | New York | United States | 11042 |
| 36 | Wake Forest Baptist Health | Winston-Salem | North Carolina | United States | 27157 |
| 37 | Oncology Hematology Care Inc | Cincinnati | Ohio | United States | 45219 |
| 38 | Northwest Cancer Specialists - Vancouver | Portland | Oregon | United States | 97227 |
| 39 | Charleston Oncology | Charleston | South Carolina | United States | 29414 |
| 40 | Saint Francis Hospital, Inc | Greenville | South Carolina | United States | 29607 |
| 41 | Tennessee Oncology PLLC | Chattanooga | Tennessee | United States | 37404 |
| 42 | Tennessee Cancer Specialists | Knoxville | Tennessee | United States | 37909 |
| 43 | Tennessee Oncology | Nashville | Tennessee | United States | 37203 |
| 44 | Texas Oncology-Bedford | Bedford | Texas | United States | 76022 |
| 45 | Texas Oncology Baylor | Dallas | Texas | United States | 75246 |
| 46 | UT Southwestern Medical Center | Dallas | Texas | United States | 75390 |
| 47 | The Center for Cancer and Blood Disorders | Fort Worth | Texas | United States | 76104 |
| 48 | Valley Cancer Associates | Harlingen | Texas | United States | 78550 |
| 49 | University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 50 | US Oncology Research Investigational Products Center | Irving | Texas | United States | 75063 |
| 51 | Hope Cancer Center | Tyler | Texas | United States | 75701 |
| 52 | Intermountain Medical Center | Murray | Utah | United States | 84107 |
| 53 | Virginia Cancer Specialists, PC | Fairfax | Virginia | United States | 22031 |
| 54 | Virginia Oncology Associates | Norfolk | Virginia | United States | 23502 |
| 55 | Blacktown Hospital | Blacktown | New South Wales | Australia | 2148 |
| 56 | Chris OBrien Lifehouse | Camperdown | New South Wales | Australia | 2050 |
| 57 | St George Hospital | Kogarah | New South Wales | Australia | 2217 |
| 58 | Liverpool Hospital | Liverpool | New South Wales | Australia | 2170 |
| 59 | Prince Charles Hospital | Chermside | Queensland | Australia | 4032 |
| 60 | Princess Alexandra Hospital | Woolloongabba | Queensland | Australia | 4102 |
| 61 | The Queen Elizabeth Hospital | Woodville South | South Australia | Australia | 5011 |
| 62 | Monash Medical Centre | Clayton | Victoria | Australia | 3168 |
| 63 | Peter MacCallum Cancer Centre | Melbourne | Victoria | Australia | 3000 |
| 64 | St John of God Healthcare | Subiaco | Western Australia | Australia | 6008 |
| 65 | Institute Jules Bordet | Brussels | Belgium | 1000 | |
| 66 | Universite Catholique de Louvain Cliniques Universitaires Saint Luc | Bruxelles | Belgium | 1200 | |
| 67 | Grand Hopital de Charleroi | Charleroi | Belgium | 6000 | |
| 68 | Universitair Ziekenhuis Antwerpen | Edegem | Belgium | 2650 | |
| 69 | Universitair Ziekenhuis Gent | Gent | Belgium | 9000 | |
| 70 | Universitair Ziekenhuis Leuven - Campus Gasthuisberg | Leuven | Belgium | 3000 | |
| 71 | Centre Hospitalier Universitaire de Liege | Liege | Belgium | 4000 | |
| 72 | AZ Delta Campus Rumbeke | Roeselare | Belgium | 8800 | |
| 73 | Algemeen Ziekenhuis Nikolaas Campus Sint Niklaas | Sint-Niklaas | Belgium | 9100 | |
| 74 | Hospital de Caridade de Ijui | Ijui | Rio Grande Do Sul | Brazil | 98700-000 |
| 75 | Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul | Porto Alegre | Rio Grande Do Sul | Brazil | 90610-000 |
| 76 | Sociedade Beneficente de Senhoras Hospital Sirio Libanes | Sao Paulo | São Paulo | Brazil | 01308-050 |
| 77 | Beneficencia Portuguesa de Sao Paulo | Sao Paulo | São Paulo | Brazil | 01321-001 |
| 78 | Oncologia Rede D´Or | Sao Paulo | São Paulo | Brazil | 04501-000 |
| 79 | Hospital Israelita Albert Einstein | Sao Paulo | São Paulo | Brazil | 05652-900 |
| 80 | Hospital de Base de Sao Jose do Rio Preto | São José Do Rio Preto | São Paulo | Brazil | 15090-000 |
| 81 | Centro de Tratamento de Tumores Botafogo | Rio de Janeiro | Brazil | 22250-905 | |
| 82 | Instituto Coi | Rio de Janeiro | Brazil | 22793-080 | |
| 83 | Fundacao Antonio Prudente - Hospital A C Camargo | São Paulo | Brazil | 01509-900 | |
| 84 | Tom Baker Cancer Centre | Calgary | Alberta | Canada | T2N 4N2 |
| 85 | Cross Cancer Institute | Edmonton | Alberta | Canada | T6G 1Z2 |
| 86 | Juravinski Cancer Centre | Hamilton | Ontario | Canada | L8V 5C2 |
| 87 | London Health Sciences Centre | London | Ontario | Canada | N6A 5W9 |
| 88 | The Ottawa Hospital Cancer Centre | Ottawa | Ontario | Canada | K1H 8L6 |
| 89 | Princess Margaret Cancer Centre | Toronto | Ontario | Canada | M5G 2M9 |
| 90 | Centre Hospitalier de L'Universite de Montreal Hopital Notre-Dame | Montreal | Quebec | Canada | H2X 3E4 |
| 91 | Herlev og Gentofte Hospital | Herlev | Denmark | 2730 | |
| 92 | Rigshospitalet | København | Denmark | 2100 | |
| 93 | Odense Universitetshospital | Odense C | Denmark | 5000 | |
| 94 | Docrates Syopasairaala | Helsinki | Finland | 00180 | |
| 95 | Helsingin Yliopistollinen Keskussairaala | Helsinki | Finland | 00290 | |
| 96 | Oulu University Hospital | Oulu | Finland | 90220 | |
| 97 | Turku University Hospital | Turku | Finland | 20520 | |
| 98 | Centre Hospitalier Regional Universitaire - Hopital Morvan | Brest | France | 29609 | |
| 99 | Centre Hospitalier Intercommunal de Créteil | Créteil | France | 94010 | |
| 100 | Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon | Grenoble | France | 38700 | |
| 101 | Centre Hospitalier Universitaire Régional de Lille - Hôpital Albert Calmette | Lille Cedex | France | 59037 | |
| 102 | Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren | Limoges Cedex | France | 87042 | |
| 103 | Centre Leon Berard | Lyon | France | 69008 | |
| 104 | Centre Hospitalier Universitaire Nord | Marseille Cedex 20 | France | 13915 | |
| 105 | Hôpital Tenon | Paris Cedex 20 | France | 75020 | |
| 106 | Institut Curie | Paris | France | 75005 | |
| 107 | Hopital Cochin | Paris | France | 75014 | |
| 108 | Hopital Bichat Claude Bernard | Paris | France | 75018 | |
| 109 | Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque | Pessac Cedex | France | 33604 | |
| 110 | Centre Hospitalier Lyon Sud | Pierre-Benite cedex | France | 69495 | |
| 111 | Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou | Rennes | France | 35033 | |
| 112 | Centre Hospitalier de Nantes - Hôpital Nord LaÃ"nnec | Saint Herblain | France | 44800 | |
| 113 | Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil | Strasbourg cedex | France | 67091 | |
| 114 | Centre Hospitalier Universitaire de Toulouse - Hopital Larrey | Toulouse Cedex 9 | France | 31059 | |
| 115 | Gustave Roussy | Villejuif | France | 94805 | |
| 116 | Evangelische Lungenklinik | Berlin | Germany | 13125 | |
| 117 | Charite Universitätsmedizin Berlin, Charité Campus Virchow-Klinikum | Berlin | Germany | 13353 | |
| 118 | Universitaetsklinikum Carl Gustav Carus | Dresden | Germany | 01307 | |
| 119 | Universitätsklinikum Essen | Essen | Germany | 45147 | |
| 120 | Klinikum Esslingen GmbH | Esslingen am Neckar | Germany | 73730 | |
| 121 | Universitätsklinikum Frankfurt/Main | Frankfurt am Main | Germany | 60590 | |
| 122 | Asklepios - Fachkliniken München-Gauting | Gauting | Germany | 82130 | |
| 123 | LungenClinic Grosshansdorf GmbH | Grosshansdorf | Germany | 22927 | |
| 124 | Studiengesellschaft Hämato Onkologie Hamburg Prof Laack und Partner | Hamburg | Germany | 20251 | |
| 125 | Universitaetsklinikum Heidelberg | Heidelberg | Germany | 69126 | |
| 126 | Klinikverbund Allgäu | Immenstadt | Germany | 87509 | |
| 127 | Universitatsklinikum Koln | Köln | Germany | 50937 | |
| 128 | Pneumologisch/onkologisch/internistisches Studienzentrum | Leipzig | Germany | 04357 | |
| 129 | Bethanien Krankenhaus | Moers | Germany | 47441 | |
| 130 | Pius-Hospital Oldenburg | Oldenburg | Germany | 26121 | |
| 131 | Agios Savvas Anticancer Hospital | Athens | Greece | 115 22 | |
| 132 | Henry Dunant Hospital Center | Athens | Greece | 11526 | |
| 133 | Sotiria General Hospital | Athens | Greece | 11527 | |
| 134 | General Oncology Hospital of Kifissia Agioi Anargyroi | Athens | Greece | 14564 | |
| 135 | Metropolitan Hospital | Athens | Greece | 18547 | |
| 136 | University Hospital of Heraklion | Heraklion - Crete | Greece | 71110 | |
| 137 | University Hospital of Larissa | Larissa | Greece | 41110 | |
| 138 | University Hospital of Patras | Patra | Greece | 26504 | |
| 139 | Theagenion Cancer Hospital | Thessaloniki | Greece | 54007 | |
| 140 | Bioclinic of Thessaloniki | Thessaloniki | Greece | 54622 | |
| 141 | Euromedica General Clinic of Thessaloniki | Thessaloniki | Greece | 54645 | |
| 142 | Agios Loukas Clinic | Thessaloniki | Greece | 55236 | |
| 143 | Semmelweis Egyetem | Budapest | Hungary | 1083 | |
| 144 | Orszagos Koranyi Pulmonologiai Intezet | Budapest | Hungary | 1121 | |
| 145 | Veszprem Megyei Tudogyogyintezet | Farkasgyepu | Hungary | 8582 | |
| 146 | Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz | Gyula | Hungary | 5700 | |
| 147 | Somogy Megyei Kaposi Mor Oktato Korhaz | Kaposvar | Hungary | 7400 | |
| 148 | Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz | Miskolc | Hungary | 3529 | |
| 149 | Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Szekesfehervar | Hungary | 8000 | |
| 150 | Szent Borbala Korhaz | Tatabanya | Hungary | 2800 | |
| 151 | Tudogyogyintezet Torokbalint | Torokbalint | Hungary | 2045 | |
| 152 | Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati | Avellino | Italy | 83100 | |
| 153 | IRCCS Istituto Tumori Giovanni Paolo II | Bari | Italy | 70124 | |
| 154 | Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi | Bologna | Italy | 40138 | |
| 155 | Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico | Catania | Italy | 95123 | |
| 156 | Azienda Ospedaliero Universitaria Careggi | Firenze | Italy | 50134 | |
| 157 | Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milano | Italy | 20122 | |
| 158 | IRCCS Ospedale San Raffaele | Milano | Italy | 20132 | |
| 159 | Fondazione IRCCS Istituto Nazionale dei Tumori | Milano | Italy | 20133 | |
| 160 | Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula | Monserrato CA | Italy | 09042 | |
| 161 | Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo | Monza (MB) | Italy | 20900 | |
| 162 | Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi | Napoli | Italy | 80131 | |
| 163 | Azienda Ospedaliera Universitaria San Luigi Gonzaga | Orbassano (TO) | Italy | 10043 | |
| 164 | Istituto Oncologico Veneto IRCCS | Padova | Italy | 35128 | |
| 165 | Azienda Unità Sanitaria Locale della Romagna Presidio ospedaliero di Ravenna | Ravenna | Italy | 48100 | |
| 166 | Azienda Ospedaliera Policlinico Umberto I | Roma | Italy | 00161 | |
| 167 | Policlinico Universitario Agostino Gemelli | Roma | Italy | 00168 | |
| 168 | Aichi Cancer Center Hospital | Nagoya-shi | Aichi | Japan | 464-8681 |
| 169 | Nagoya University Hospital | Nagoya-shi | Aichi | Japan | 466-8560 |
| 170 | Chiba Cancer Center | Chiba-shi | Chiba | Japan | 260-8717 |
| 171 | National Cancer Center Hospital East | Kashiwa-shi | Chiba | Japan | 277-8577 |
| 172 | National Hospital Organization Shikoku Cancer Center | Matsuyama-shi | Ehime | Japan | 791-0280 |
| 173 | National Hospital Organization Kyushu Cancer Center | Fukuoka-shi | Fukuoka | Japan | 811-1395 |
| 174 | Kyushu University Hospital | Fukuoka-shi | Fukuoka | Japan | 812-8582 |
| 175 | Hospital of the University of Occupational and Environmental Health | Kitakyushu-shi | Fukuoka | Japan | 807-8556 |
| 176 | Chugoku Central Hospital of Japan Mutual Aid Association of Public School Teachers | Fukuyama-shi | Hiroshima | Japan | 720-0001 |
| 177 | Hiroshima University Hospital | Hiroshima-shi | Hiroshima | Japan | 734-8551 |
| 178 | National Hospital Organization Hokkaido Cancer Center | Sapporo-shi | Hokkaido | Japan | 003-0804 |
| 179 | Hyogo Cancer Center | Akashi-shi | Hyogo | Japan | 673-8558 |
| 180 | National Hospital Organization Himeji Medical Center | Himeji-shi | Hyogo | Japan | 670-8520 |
| 181 | Itami City Hospital | Itami-shi | Hyogo | Japan | 664-8540 |
| 182 | Kobe City Medical Center General Hospital | Kobe-shi | Hyogo | Japan | 650-0047 |
| 183 | Kanazawa University Hospital | Kanazawa-shi | Ishikawa | Japan | 920-8641 |
| 184 | St Marianna University School of Medicine Hospital | Kawasaki-shi | Kanagawa | Japan | 216-8511 |
| 185 | Kitasato University Hospital | Sagamihara-shi | Kanagawa | Japan | 252-0375 |
| 186 | Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center | Yokohama-shi | Kanagawa | Japan | 241-8515 |
| 187 | Kyoto University Hospital | Kyoto-shi | Kyoto | Japan | 606-8507 |
| 188 | Miyagi Cancer Center | Natori-shi | Miyagi | Japan | 981-1293 |
| 189 | Sendai Kousei Hospital | Sendai-shi | Miyagi | Japan | 980-0873 |
| 190 | Niigata Cancer Center Hospital | Niigata-shi | Niigata | Japan | 951-8566 |
| 191 | Okayama University Hospital | Okayama-shi | Okayama | Japan | 700-8558 |
| 192 | Osaka Habikino Medical Center | Habikino-shi | Osaka | Japan | 583-8588 |
| 193 | Kansai Medical University Hospital | Hirakata-shi | Osaka | Japan | 573-1191 |
| 194 | Osaka City General Hospital | Osaka-shi | Osaka | Japan | 534-0021 |
| 195 | Osaka International Cancer Institute | Osaka-shi | Osaka | Japan | 541-8567 |
| 196 | Kindai University Hospital | Osakasayama-shi | Osaka | Japan | 589-8511 |
| 197 | National Hospital Organization Kinki-chuo Chest Medical Center | Sakai-shi | Osaka | Japan | 591-8555 |
| 198 | Saga-ken Medical Centre Koseikan | Saga-shi | Saga | Japan | 840-8571 |
| 199 | Saitama Cancer Center | Kitaadachi-gun | Saitama | Japan | 362-0806 |
| 200 | Shiga University of Medical Science Hospital | Otsu-shi | Shiga | Japan | 520-2192 |
| 201 | Juntendo University Hospital | Bunkyo-ku | Tokyo | Japan | 113-8431 |
| 202 | National Cancer Center Hospital | Chuo-ku | Tokyo | Japan | 104-0045 |
| 203 | Cancer Institute Hospital of Japanese Foundation for Cancer Research | Koto-ku | Tokyo | Japan | 135-8550 |
| 204 | Tottori University Hospital | Yonago-shi | Tottori | Japan | 683-8504 |
| 205 | Wakayama Medical University Hospital | Wakayama-shi | Wakayama | Japan | 641-8510 |
| 206 | National Hospital Organization Iwakuni Clinical Center | Iwakuni-shi | Yamaguchi | Japan | 740-8510 |
| 207 | National Hospital Organization Yamaguchi Ube Medical Center | Ube-shi | Yamaguchi | Japan | 755-0241 |
| 208 | Chungbuk National University Hospital | Cheongju-si, Chungcheongbuk-do | Korea, Republic of | 28644 | |
| 209 | National Cancer Center | Goyang-si Gyeonggi-do | Korea, Republic of | 10408 | |
| 210 | Cha Bundang Medical Center, Cha University | Seongnam-si, Gyeonggi-do | Korea, Republic of | 13496 | |
| 211 | Seoul National University Bundang Hospital | Seongnam-si, Gyeonggi-do | Korea, Republic of | 13620 | |
| 212 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 | |
| 213 | Kangbuk Samsung Hospital | Seoul | Korea, Republic of | 03181 | |
| 214 | Severance Hospital Yonsei University Health System | Seoul | Korea, Republic of | 03722 | |
| 215 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
| 216 | Samsung medical center | Seoul | Korea, Republic of | 06351 | |
| 217 | The Catholic University of Korea Seoul St Marys Hospital | Seoul | Korea, Republic of | 06591 | |
| 218 | Ulsan University Hospital | Ulsan | Korea, Republic of | 44033 | |
| 219 | Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis | Amsterdam | Netherlands | 1066 CX | |
| 220 | Universitair Medisch Centrum Groningen | Groningen | Netherlands | 9713 GZ | |
| 221 | Radboudumc | Nijmegen | Netherlands | 6525 GA | |
| 222 | Erasmus Medisch Centrum | Rotterdam | Netherlands | 3015 GD | |
| 223 | Universitair Medisch Centrum Utrecht | Utrecht | Netherlands | 3584 CX | |
| 224 | Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | 80-214 | |
| 225 | Instytut Genetyki i Immunologii GENIM Spzoo | Lublin | Poland | 20-609 | |
| 226 | Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu | Poznan | Poland | 60-569 | |
| 227 | Centrum Onkologii Instytut im Marii Sklodowskiej-Curie | Warszawa | Poland | 02-781 | |
| 228 | Dolnoslaskie Centrum Onkologii we Wroclawiu | Wroclaw | Poland | 53-413 | |
| 229 | Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente | Lisboa | Portugal | 1769-001 | |
| 230 | Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano | Matosinhos | Portugal | 4464-513 | |
| 231 | Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio | Porto | Portugal | 4099-001 | |
| 232 | Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE | Porto | Portugal | 4200-072 | |
| 233 | Centro Hospitalar Universitario de Sao Joao EPE - Hospital Sao Joao | Porto | Portugal | 4200-319 | |
| 234 | Clinical hospital 2, Group of companies medsi | Moscow | Russian Federation | 125284 | |
| 235 | LLC Tonus | Nizhniy Novgorod | Russian Federation | 603089 | |
| 236 | Omsk Regional Clinical Oncology Dispensary | Omsk | Russian Federation | 644013 | |
| 237 | FSBI Scientific and Research Oncology Institute named after N N Petrov | Saint-Petersburg | Russian Federation | 197758 | |
| 238 | Saint Petersburg scientifical practical center of specialized kinds of medical care oncological | Saint-Petersburg | Russian Federation | 197758 | |
| 239 | Hospital Regional Universitario de Malaga | Malaga | AndalucÃ-a | Spain | 29011 |
| 240 | Hospital Universitario Insular de Gran Canaria | Las Palmas de Gran Canaria | Canarias | Spain | 35016 |
| 241 | Hospital Universitari Vall d Hebron | Barcelona | Cataluña | Spain | 08035 |
| 242 | Hospital Clinic i Provincial de Barcelona | Barcelona | Cataluña | Spain | 08036 |
| 243 | Hospital de la Santa Creu i Sant Pau | Barcelona | Cataluña | Spain | 08041 |
| 244 | Instituto Catalan de Oncologia Hospital Duran i Reynals | Hospitalet de Llobregat | Cataluña | Spain | 08907 |
| 245 | Hospital Clinico Universitario de Valencia | Valencia | Comunidad Valenciana | Spain | 46010 |
| 246 | Complexo Hospitalario Universitario A Coruña Hospital Teresa Herrera | A Coruña | Galicia | Spain | 15006 |
| 247 | Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | Spain | 28222 |
| 248 | Hospital Universitario Ramon y Cajal | Madrid | Spain | 28034 | |
| 249 | Hospital Universitario 12 de Octubre | Madrid | Spain | 28041 | |
| 250 | Hospital Universitario La Paz | Madrid | Spain | 28046 | |
| 251 | Gavle Sjukhus | Gavle | Sweden | 801 87 | |
| 252 | Sahlgrenska Universitetssjukhuset | Goteborg | Sweden | 413 45 | |
| 253 | Universitetssjukhuset i Linkoping | Linkoping | Sweden | 581 85 | |
| 254 | Skanes Universitetssjukhus | Lund | Sweden | 221 85 | |
| 255 | Karolinska Universitetssjukhuset Solna | Stockholm | Sweden | 171 64 | |
| 256 | Norrlands Universitetssjukhus | Umea | Sweden | 901 85 | |
| 257 | Universitaetsspital Basel | Basel | Switzerland | 4031 | |
| 258 | Inselspital Bern | Bern | Switzerland | 3010 | |
| 259 | Hopitaux Universitaires de Geneve | Geneve | Switzerland | 1205 | |
| 260 | Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland | 1011 | |
| 261 | Kantonsspital Winterthur | Winterthur | Switzerland | 8401 | |
| 262 | Universitaetsspital Zuerich | Zurich | Switzerland | 8091 | |
| 263 | China Medical University Hospital | Taichung | Taiwan | 40447 | |
| 264 | Veterans General Hospital - Taichung | Taichung | Taiwan | 40705 | |
| 265 | National Cheng Kung University Hospital | Tainan | Taiwan | 70403 | |
| 266 | National Taiwan University Hospital | Taipei | Taiwan | 10002 | |
| 267 | Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust | Cambridge | United Kingdom | CB2 0QQ | |
| 268 | Western General Hospital | Edinburgh | United Kingdom | EH4 2XU | |
| 269 | Royal Marsden Hospital | London | United Kingdom | SW3 6JJ | |
| 270 | Sarah Cannon Research Institute UK | London | United Kingdom | W1G 6AD | |
| 271 | Christie Hospital | Manchester | United Kingdom | M20 4BX | |
| 272 | Nottingham City Hospital | Nottingham | United Kingdom | NG5 1PB | |
| 273 | Churchill Hospital | Oxford | United Kingdom | OX3 7LJ | |
| 274 | Royal Marsden Hospital | Sutton | United Kingdom | SM2 5PT |
Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT04303780
Other Study ID Numbers:
- 20190009
- 2019-003582-18
First Posted:
Mar 11, 2020
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: