Studies
| Study First Submitted Date | 2020-12-08 |
| Study First Posted Date | 2020-12-14 |
| Last Update Posted Date | 2023-08-04 |
| Verification Month Year | August 2023 |
| Verification Date | 2023-08-31 |
| Last Update Posted Date | 2023-08-04 |
Facilities
| Sequence: | 200443818 | Sequence: | 200443819 | Sequence: | 200443820 | Sequence: | 200443821 | Sequence: | 200443822 | Sequence: | 200443823 | Sequence: | 200443824 | Sequence: | 200443825 | Sequence: | 200443826 | Sequence: | 200443827 | Sequence: | 200443828 | Sequence: | 200443829 | Sequence: | 200443830 | Sequence: | 200443831 | Sequence: | 200443832 | Sequence: | 200443833 | Sequence: | 200443834 | Sequence: | 200443835 | Sequence: | 200443836 | Sequence: | 200443837 | Sequence: | 200443838 | Sequence: | 200443839 | Sequence: | 200443840 | Sequence: | 200443841 | Sequence: | 200443842 | Sequence: | 200443843 | Sequence: | 200443844 | Sequence: | 200443845 | Sequence: | 200443846 | Sequence: | 200443847 | Sequence: | 200443848 | Sequence: | 200443849 | Sequence: | 200443850 | Sequence: | 200443851 | Sequence: | 200443852 | Sequence: | 200443853 | Sequence: | 200443854 | Sequence: | 200443855 | Sequence: | 200443856 | Sequence: | 200443857 | Sequence: | 200443858 | Sequence: | 200443859 | Sequence: | 200443860 | Sequence: | 200443861 | Sequence: | 200443862 | Sequence: | 200443863 | Sequence: | 200443864 | Sequence: | 200443865 | Sequence: | 200443866 | Sequence: | 200443867 | Sequence: | 200443868 | Sequence: | 200443869 | Sequence: | 200443870 | Sequence: | 200443871 | Sequence: | 200443872 |
| Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available | Status | Available |
| Name | Clearview Cancer Institute | Name | Alaska Oncology and Hematology LLC | Name | Ironwood Cancer and Research Center | Name | Arizona Oncology Associates Professional Corporation | Name | San Luis Valley Health Regional Medical Center | Name | Kaiser Permanente | Name | Sacred Heart Medical Oncology Group | Name | Cancer Care Specialists of Central Illinois | Name | McFarland Clinic PC | Name | Des Moines Oncology Research Association | Name | Saint Joseph East | Name | Louisiana Hematology Oncology Associates | Name | Northern Light Cancer Center | Name | University of Pittsburgh Medical Center Western Maryland | Name | Maryland Oncology Hematology, PA | Name | Dana Farber Cancer Institute | Name | Mid Michigan Medical Center | Name | Saint Lukes Cancer Institute | Name | Oncology Hematology Associates | Name | Nebraska Cancer Specialists | Name | Englewood Hospital and Medical Center | Name | Overlook Medical Center | Name | Wake Forest Baptist Comprehensive Cancer Research Center | Name | Cleveland Clinic Taussig Cancer Institute | Name | LeHigh Valley Hospital | Name | Fox Chase Cancer Center | Name | Scranton Hematology Oncology | Name | Erlanger East Hospital | Name | Baptist Cancer Center | Name | Saint Marys Medical Center | Name | Instituto Médico Especializado Alexander Fleming | Name | Hospital Aleman | Name | Cemic | Name | Clínica Universitaria Privada Reina Fabiola | Name | Hospital Sirio Libanes | Name | Personal Oncologia de Precisao e Personalizada | Name | Instituto de Oncologia do Parana | Name | Liga Norte-Riograndense Contra O Cancer | Name | YNOVA Pesquisa Clinica | Name | Fundacao Pio 12 Hospital de Cancer de Barretos | Name | Oncoclinicas Rio de Janeiro S A | Name | Meir Medical Center | Name | Shaare Zedek Medical Center | Name | Rabin Medical Center | Name | King Fahad Specialist Hospital | Name | King Abdulaziz Medical City – National Guard Hospital | Name | King Saud University Medical City-King Khalid University Hospital | Name | King Faisal Specialist Hospital | Name | Kaohsiung Chang Gung Memorial Hospital | Name | Chung Shan Medical University Hospital | Name | Veterans General Hospital – Taichung | Name | National Cheng Kung University Hospital | Name | National Taiwan University Hospital | Name | Taipei Veterans General Hospital | Name | Linkou Chang Gung Memorial Hospital |
| City | Huntsville | City | Anchorage | City | Chandler | City | Tucson | City | Alamosa | City | Lone Tree | City | Pensacola | City | Decatur | City | Ames | City | Des Moines | City | Lexington | City | Baton Rouge | City | Brewer | City | Cumberland | City | Rockville | City | Boston | City | Midland | City | Kansas City | City | Springfield | City | Omaha | City | Englewood | City | Summit | City | Winston-Salem | City | Cleveland | City | Allentown | City | Philadelphia | City | Scranton | City | Chattanooga | City | Memphis | City | Huntington | City | Capital Federal | City | Ciudad Autonoma de Buenos Aires | City | Ciudad Autonoma de Buenos Aires | City | Córdoba | City | Brasilia | City | Belo Horizonte | City | Curitiba | City | Natal | City | Florianopolis | City | Barretos | City | Rio De Janeiro/RJ | City | Kfar Saba | City | Petach Tikva | City | Petah Tikva | City | Dammam | City | Riyadh | City | Riyadh | City | Riyadh | City | Kaohsiung | City | Taichung | City | Taichung | City | Tainan | City | Taipei | City | Taipei | City | Taoyuan |
| State | Alabama | State | Alaska | State | Arizona | State | Arizona | State | Colorado | State | Colorado | State | Florida | State | Illinois | State | Iowa | State | Iowa | State | Kentucky | State | Louisiana | State | Maine | State | Maryland | State | Maryland | State | Massachusetts | State | Michigan | State | Missouri | State | Missouri | State | Nebraska | State | New Jersey | State | New Jersey | State | North Carolina | State | Ohio | State | Pennsylvania | State | Pennsylvania | State | Pennsylvania | State | Tennessee | State | Tennessee | State | West Virginia | State | Buenos Aires | State | Buenos Aires | State | Buenos Aires | State | Distrito Federal | State | Minas Gerais | State | Paraná | State | Rio Grande Do Norte | State | Santa Catarina | State | São Paulo | ||||||||||||||||||||||||||||||||
| Zip | 35805 | Zip | 99508 | Zip | 85224 | Zip | 85711 | Zip | 81101 | Zip | 80124 | Zip | 32504 | Zip | 62526 | Zip | 50010 | Zip | 50309 | Zip | 40509 | Zip | 70809 | Zip | 04412 | Zip | 21502 | Zip | 20850 | Zip | 02215 | Zip | 48640 | Zip | 64111 | Zip | 65807 | Zip | 68130 | Zip | 07631 | Zip | 91010 | Zip | 27157 | Zip | 44195 | Zip | 18103 | Zip | 19111 | Zip | 18510 | Zip | 37421 | Zip | 38120 | Zip | 25705 | Zip | C1426ANZ | Zip | C1118AAT | Zip | C1431FWO | Zip | X5004FHP | Zip | 70200-730 | Zip | 30130-090 | Zip | 80040-170 | Zip | 59075-740 | Zip | 88034-000 | Zip | 14784-400 | Zip | 22250-905 | Zip | 4428164 | Zip | 4941492 | Zip | 4941492 | Zip | 32253 | Zip | 11426 | Zip | 12372 | Zip | 12713 | Zip | 83301 | Zip | 40201 | Zip | 40705 | Zip | 70403 | Zip | 10002 | Zip | 11217 | Zip | 33305 |
| Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | Argentina | Country | Argentina | Country | Argentina | Country | Argentina | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Israel | Country | Israel | Country | Israel | Country | Saudi Arabia | Country | Saudi Arabia | Country | Saudi Arabia | Country | Saudi Arabia | Country | Taiwan | Country | Taiwan | Country | Taiwan | Country | Taiwan | Country | Taiwan | Country | Taiwan | Country | Taiwan |
Browse Interventions
| Sequence: | 96216040 | Sequence: | 96216041 | Sequence: | 96216042 | Sequence: | 96216043 | Sequence: | 96216044 |
| Mesh Term | Sotorasib | Mesh Term | Immune Checkpoint Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Antineoplastic Agents, Immunological | Mesh Term | Antineoplastic Agents |
| Downcase Mesh Term | sotorasib | Downcase Mesh Term | immune checkpoint inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | antineoplastic agents, immunological | Downcase Mesh Term | antineoplastic agents |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
| Sequence: | 52274502 | Sequence: | 52274503 | Sequence: | 52274504 |
| Name | Non Small-cell Lung Cancer | Name | Locally Advanced Unresectable NSCLC | Name | Locally Advanced Metastatic NSCLC |
| Downcase Name | non small-cell lung cancer | Downcase Name | locally advanced unresectable nsclc | Downcase Name | locally advanced metastatic nsclc |
Id Information
| Sequence: | 40233412 |
| Id Source | org_study_id |
| Id Value | 20190436 |
Countries
| Sequence: | 42650168 | Sequence: | 42650169 | Sequence: | 42650170 | Sequence: | 42650171 | Sequence: | 42650172 | Sequence: | 42650173 |
| Name | United States | Name | Argentina | Name | Brazil | Name | Israel | Name | Saudi Arabia | Name | Taiwan |
| Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False |
Interventions
| Sequence: | 52586811 |
| Intervention Type | Drug |
| Name | AMG 510 |
| Description | Administered as an oral tablet. |
Keywords
| Sequence: | 80014986 | Sequence: | 80014987 |
| Name | NSCLC | Name | KRAS p.G12C Mutation |
| Downcase Name | nsclc | Downcase Name | kras p.g12c mutation |
Browse Conditions
| Sequence: | 193881062 | Sequence: | 193881063 | Sequence: | 193881064 | Sequence: | 193881065 | Sequence: | 193881066 | Sequence: | 193881067 | Sequence: | 193881068 | Sequence: | 193881069 | Sequence: | 193881070 | Sequence: | 193881071 |
| Mesh Term | Carcinoma, Non-Small-Cell Lung | Mesh Term | Carcinoma, Bronchogenic | Mesh Term | Bronchial Neoplasms | Mesh Term | Lung Neoplasms | Mesh Term | Respiratory Tract Neoplasms | Mesh Term | Thoracic Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases |
| Downcase Mesh Term | carcinoma, non-small-cell lung | Downcase Mesh Term | carcinoma, bronchogenic | Downcase Mesh Term | bronchial neoplasms | Downcase Mesh Term | lung neoplasms | Downcase Mesh Term | respiratory tract neoplasms | Downcase Mesh Term | thoracic neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48415739 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Amgen |
Overall Officials
| Sequence: | 29341103 |
| Role | Study Director |
| Name | MD |
| Affiliation | Amgen |
Central Contacts
| Sequence: | 12033645 |
| Contact Type | primary |
| Name | Amgen Call Center |
| Phone | 866-572-6436 |
| medinfo@amgen.com | |
| Role | Contact |
Eligibilities
| Sequence: | 30825375 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | 99 Years |
| Criteria | Inclusion Criteria Age ≥ 18 years Ineligibility for participation in any Amgen-sponsored ongoing clinical study of the investigational product Pathologically documented, locally-advanced and unresectable or metastatic Non Small-Cell Lung Cancer (NSCLC) with KRAS p.G12C mutation confirmed through molecular testing Exhausted other standard of care options for locally advanced and unresectable or metastatic NSCLC disease including platinum-based combination chemotherapy and programmed cell death protein 1/programmed death-ligand 1 (PD 1/PD-L1) immunotherapy (unless medically contraindicated) Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 Exclusion Criteria Mixed small-cell lung cancer or mixed NSCLC histology Active brain metastases Active hepatitis B or hepatitis C virus Current active malignancy other than NSCLC Currently or previously enrolled in a prior sotorasib study unless radiographic disease progression confirmed, able to remain on long term follow up of their original protocol and receives medical monitor approval Female participants planning to become pregnant while on study through 7 days after the last dose of sotorasib |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254119528 |
| Number Of Facilities | 55 |
| Registered In Calendar Year | 2020 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Maximum Age Num | 99 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
Intervention Other Names
| Sequence: | 26720978 | Sequence: | 26720979 | Sequence: | 26720980 |
| Intervention Id | 52586811 | Intervention Id | 52586811 | Intervention Id | 52586811 |
| Name | Sotorasib | Name | Lumakras (US) | Name | Lumykras (UK) |
Links
| Sequence: | 4396244 |
| Url | http://www.amgentrials.com |
| Description | AmgenTrials clinical trials website |
Responsible Parties
| Sequence: | 28937724 |
| Responsible Party Type | Sponsor |