Non Small-cell Lung CancerNCT04667234
Expanded Access of Sotorasib
A study testing AMG 510 in people with Non Small-cell Lung Cancer and Locally Advanced Unresectable NSCLC, run by Amgen at 55 sites in 6 countries.
Trial summary
The primary objective of this study is to provide expanded access to and characterize the safety profile of Sotorasib in participants with previously treated locally advanced/unresectable/metastatic non small-cell lung cancer (NSCLC) with KRAS p.G12C mutation in a real-world setting. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Non Small-cell Lung Cancer, Locally Advanced Unresectable NSCLC, Locally Advanced Metastatic NSCLC
- What is being tested?
- AMG 510
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 55 sitesin 6 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
55 sites in 6 countries.
55 sites in 6 countries
United States30 sites
San Luis Valley Health Regional Medical Center
Alamosa, Colorado, 81101
LeHigh Valley Hospital
Allentown, Pennsylvania, 18103
McFarland Clinic PC
Ames, Iowa, 50010
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Louisiana Hematology Oncology Associates
Baton Rouge, Louisiana, 70809
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Northern Light Cancer Center
Brewer, Maine, 04412
Ironwood Cancer and Research Center
Chandler, Arizona, 85224
Erlanger East Hospital
Chattanooga, Tennessee, 37421
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, 44195
University of Pittsburgh Medical Center Western Maryland
Cumberland, Maryland, 21502
Cancer Care Specialists of Central Illinois
Decatur, Illinois, 62526
Des Moines Oncology Research Association
Des Moines, Iowa, 50309
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
Saint Marys Medical Center
Huntington, West Virginia, 25705
Clearview Cancer Institute
Huntsville, Alabama, 35805
Saint Lukes Cancer Institute
Kansas City, Missouri, 64111
Saint Joseph East
Lexington, Kentucky, 40509
Kaiser Permanente
Lone Tree, Colorado, 80124
Baptist Cancer Center
Memphis, Tennessee, 38120
Mid Michigan Medical Center
Midland, Michigan, 48640
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Sacred Heart Medical Oncology Group
Pensacola, Florida, 32504
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Maryland Oncology Hematology, PA
Rockville, Maryland, 20850
Scranton Hematology Oncology
Scranton, Pennsylvania, 18510
Oncology Hematology Associates
Springfield, Missouri, 65807
Overlook Medical Center
Summit, New Jersey, 91010
Arizona Oncology Associates Professional Corporation
Tucson, Arizona, 85711
Wake Forest Baptist Comprehensive Cancer Research Center
Winston-Salem, North Carolina, 27157
Brazil7 sites
Fundacao Pio 12 Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400
Personal Oncologia de Precisao e Personalizada
Belo Horizonte, Minas Gerais, 30130-090
Hospital Sirio Libanes
Brasília, Federal District, 70200-730
Instituto de Oncologia do Parana
Curitiba, Paraná, 80040-170
YNOVA Pesquisa Clinica
Florianópolis, Santa Catarina, 88034-000
Liga Norte-Riograndense Contra O Cancer
Natal, Rio Grande do Norte, 59075-740
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro/RJ, 22250-905
Taiwan7 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Kaohsiung, 83301
Chung Shan Medical University Hospital
Taichung, Taichung, 40201
Veterans General Hospital - Taichung
Taichung, Taichung, 40705
National Cheng Kung University Hospital
Tainan, Tainan, 70403
National Taiwan University Hospital
Taipei, Taipei, 10002
Taipei Veterans General Hospital
Taipei, Taipei, 11217
Linkou Chang Gung Memorial Hospital
Taoyuan, Taoyuan, 33305
Argentina4 sites
Instituto Médico Especializado Alexander Fleming
Capital Federal, Buenos Aires, C1426ANZ
Hospital Aleman
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1118AAT
Cemic
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO
Clínica Universitaria Privada Reina Fabiola
Córdoba, Córdoba Province, X5004FHP
Saudi Arabia4 sites
King Fahad Specialist Hospital
Dammam, 32253
King Abdulaziz Medical City - National Guard Hospital
Riyadh, 11426
King Saud University Medical City-King Khalid University Hospital
Riyadh, 12372
King Faisal Specialist Hospital
Riyadh, 12713
Israel3 sites
Meir Medical Center
Kfar Saba, 4428164
Rabin Medical Center
Petah Tikva, 4941492
Shaare Zedek Medical Center
Petah Tikva, 4941492
About this study
Official title: A Multicenter, Open-label, Single-arm, Expanded Access Protocol of Sotorasib for the Treatment of Subjects With Previously Treated Locally Advanced Unresectable/Metastatic NSCLC With KRAS p.G12C Mutation
The primary objective of this study is to provide expanded access to and characterize the safety profile of Sotorasib in participants with previously treated locally advanced/unresectable/metastatic non small-cell lung cancer (NSCLC) with KRAS p.G12C mutation in a real-world setting.
- Conditions
- Non Small-cell Lung Cancer, Locally Advanced Unresectable NSCLC, Locally Advanced Metastatic NSCLC
- Being tested
- AMG 510
- Keywords
- NSCLC, KRAS p.G12C Mutation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 510Drug
Also called Sotorasib, Lumakras (US), Lumykras (UK)
Administered as an oral tablet.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small-cell Lung CancerStudies 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
- Expanded access
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
- NCT04667234
- Sponsor's protocol ID
- 20190436
- Status last verified
- Aug 2025
- First submitted
- 8 Dec 2020
- Last updated
- 20 Aug 2026
- Results posted
- No
Publications
Novello S, Rabinovich NM, Shih JY, Pelizzari G, Stevenson J, Majem M, Ferreira CG, Petty WJ, Arriola E, Castagneris N, De Castro J, Morbeck I, Bauman J, Toschi L, Zer A, Metro G, Kalmadi S, Martinez AA, Al Husaini H, Meloni AR, Nduka C, Ardito-Abraham C, Xia C, Awad MM. Sotorasib in Advanced KRAS G12C-Mutated NSCLC: Results From the Global Expanded Access Program, Including Patients With Poor Performance Status and a History of CNS Metastases. JTO Clin Res Rep. 2026 Feb 13;7(5):100974. doi: 10.1016/j.jtocrr.2026.100974. eCollection 2026 May.
PubMed 42006282
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single-arm, Expanded Access Protocol of Sotorasib for the Treatment of Subjects With Previously Treated Locally Advanced Unresectable/Metastatic NSCLC With KRAS p.G12C Mutation
- ClinicalTrials.gov ID
- NCT04667234
- Acronym / sponsor ID
- 20190436
- Conditions
- Non Small-cell Lung Cancer, Locally Advanced Unresectable NSCLC, Locally Advanced Metastatic NSCLC
- Keywords
- NSCLC, KRAS p.G12C Mutation
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to provide expanded access to and characterize the safety profile of Sotorasib in participants with previously treated locally advanced/unresectable/metastatic non small-cell lung cancer (NSCLC) with KRAS p.G12C mutation in a real-world setting.
Study design
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 510Also: Sotorasib, Lumakras (US), Lumykras (UK)Administered as an oral tablet. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 42006282Novello S, Rabinovich NM, Shih JY, Pelizzari G, Stevenson J, Majem M, Ferreira CG, Petty WJ, Arriola E, Castagneris N, De Castro J, Morbeck I, Bauman J, Toschi L, Zer A, Metro G, Kalmadi S, Martinez AA, Al Husaini H, Meloni AR, Nduka C, Ardito-Abraham C, Xia C, Awad MM. Sotorasib in Advanced KRAS G12C-Mutated NSCLC: Results From the Global Expanded Access Program, Including Patients With Poor Performance Status and a History of CNS Metastases. JTO Clin Res Rep. 2026 Feb 13;7(5):100974. doi: 10.1016/j.jtocrr.2026.100974. eCollection 2026 May.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
55 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMG 510 in people with Non Small-cell Lung Cancer and Locally Advanced Unresectable NSCLC, run by Amgen at 55 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Brazil, Taiwan, Argentina, Saudi Arabia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04667234, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.