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Can a targeted pill offer hope for stubborn lung cancer?

NCT ID NCT04667234

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended) This study
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study provides expanded access to sotorasib, an oral drug designed to target a specific genetic mutation (KRAS G12C) found in some non-small cell lung cancers. It is for adults with advanced or metastatic disease who have already tried standard treatments, including chemotherapy, and cannot join other clinical trials. The goal is to give these patients a chance to receive the drug and to gather more information about its safety in a real-world setting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sotorasib (AMG 510), an oral tablet
What this could lead to
If it works, this could provide a treatment option for people with KRAS G12C-mutant lung cancer who have no other choices left.
What could go wrong
This is an expanded access program, not a controlled trial, so it may not prove effectiveness. Side effects are possible, and it is only for those who qualify.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally advanced metastatic NSCLC Locally advanced unresectable NSCLC Non-small cell lung cancer

Contacts and locations

Locations

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508, United States

  • Arizona Oncology Associates Professional Corporation

    Tucson, Arizona, 85711, United States

  • Baptist Cancer Center

    Memphis, Tennessee, 38120, United States

  • Cancer Care Specialists of Central Illinois

    Decatur, Illinois, 62526, United States

  • Cemic

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO, Argentina

  • Chung Shan Medical University Hospital

    Taichung, Taichung, 40201, Taiwan

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805, United States

  • Cleveland Clinic Taussig Cancer Institute

    Cleveland, Ohio, 44195, United States

  • Clínica Universitaria Privada Reina Fabiola

    Córdoba, Córdoba Province, X5004FHP, Argentina

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Des Moines Oncology Research Association

    Des Moines, Iowa, 50309, United States

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631, United States

  • Erlanger East Hospital

    Chattanooga, Tennessee, 37421, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Fundacao Pio 12 Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • Hospital Aleman

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1118AAT, Argentina

  • Hospital Sirio Libanes

    Brasília, Federal District, 70200-730, Brazil

  • Instituto Médico Especializado Alexander Fleming

    Capital Federal, Buenos Aires, C1426ANZ, Argentina

  • Instituto de Oncologia do Parana

    Curitiba, Paraná, 80040-170, Brazil

  • Ironwood Cancer and Research Center

    Chandler, Arizona, 85224, United States

  • Kaiser Permanente

    Lone Tree, Colorado, 80124, United States

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, Kaohsiung, 83301, Taiwan

  • King Abdulaziz Medical City - National Guard Hospital

    Riyadh, 11426, Saudi Arabia

  • King Fahad Specialist Hospital

    Dammam, 32253, Saudi Arabia

  • King Faisal Specialist Hospital

    Riyadh, 12713, Saudi Arabia

  • King Saud University Medical City-King Khalid University Hospital

    Riyadh, 12372, Saudi Arabia

  • LeHigh Valley Hospital

    Allentown, Pennsylvania, 18103, United States

  • Liga Norte-Riograndense Contra O Cancer

    Natal, Rio Grande do Norte, 59075-740, Brazil

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, Taoyuan, 33305, Taiwan

  • Louisiana Hematology Oncology Associates

    Baton Rouge, Louisiana, 70809, United States

  • Maryland Oncology Hematology, PA

    Rockville, Maryland, 20850, United States

  • McFarland Clinic PC

    Ames, Iowa, 50010, United States

  • Meir Medical Center

    Kfar Saba, 4428164, Israel

  • Mid Michigan Medical Center

    Midland, Michigan, 48640, United States

  • National Cheng Kung University Hospital

    Tainan, Tainan, 70403, Taiwan

  • National Taiwan University Hospital

    Taipei, Taipei, 10002, Taiwan

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130, United States

  • Northern Light Cancer Center

    Brewer, Maine, 04412, United States

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro/RJ, 22250-905, Brazil

  • Oncology Hematology Associates

    Springfield, Missouri, 65807, United States

  • Overlook Medical Center

    Summit, New Jersey, 91010, United States

  • Personal Oncologia de Precisao e Personalizada

    Belo Horizonte, Minas Gerais, 30130-090, Brazil

  • Rabin Medical Center

    Petah Tikva, 4941492, Israel

  • Sacred Heart Medical Oncology Group

    Pensacola, Florida, 32504, United States

  • Saint Joseph East

    Lexington, Kentucky, 40509, United States

  • Saint Lukes Cancer Institute

    Kansas City, Missouri, 64111, United States

  • Saint Marys Medical Center

    Huntington, West Virginia, 25705, United States

  • San Luis Valley Health Regional Medical Center

    Alamosa, Colorado, 81101, United States

  • Scranton Hematology Oncology

    Scranton, Pennsylvania, 18510, United States

  • Shaare Zedek Medical Center

    Petah Tikva, 4941492, Israel

  • Taipei Veterans General Hospital

    Taipei, Taipei, 11217, Taiwan

  • University of Pittsburgh Medical Center Western Maryland

    Cumberland, Maryland, 21502, United States

  • Veterans General Hospital - Taichung

    Taichung, Taichung, 40705, Taiwan

  • Wake Forest Baptist Comprehensive Cancer Research Center

    Winston-Salem, North Carolina, 27157, United States

  • YNOVA Pesquisa Clinica

    Florianópolis, Santa Catarina, 88034-000, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.