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New targeted pill shows promise for Hard-to-Treat lung cancer

NCT ID NCT04933695

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 Results may not be published yet.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 This study
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)
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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This study tested a daily oral drug called sotorasib in 42 adults with advanced (stage IV) non-small cell lung cancer that has a specific KRAS G12C mutation and has not been treated before. The goal was to see how well the drug shrinks tumors and how safe it is. Participants received either 960 mg or 240 mg of sotorasib daily. The trial is now complete.

What this could mean

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

Active substance
Sotorasib (also known as AMG 510, Lumykras, Lumakras) – a daily oral tablet
What this could lead to
If successful, sotorasib could become a new first-line treatment option for people with a specific genetic mutation in advanced lung cancer, potentially shrinking tumors and delaying progression.
What could go wrong
This is a small, early-phase (Phase 2) study with only 42 participants, so results may not apply to everyone. The drug may cause side effects, and not all patients will respond.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

42 people

The number who actually took part.

Started

Jan 2022

Finished

May 2025

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 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Adult (= or \> 18 years old) with NSCLC * Untreated Stage IV metastatic disease. Participants who received adjuvant or neoadjuvant anti-tumor therapy are eligible if the adjuvant/neoadjuvant therapy was completed greater than 12 months prior to the development of metastatic stage IV disease * Pathologically documented metastatic NSCLC with KRAS G12C mutation (local confirmation) * Programmed death-ligand 1 (PD-L1) TPS Score \< 1% and/or serine/threonine kinase 11 (STK11) co-mutation (local confirmation) * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 * No active brain metastases * Measurable disease per investigator interpretation using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria Exclusion Criteria: * Mixed small-cell lung cancer and NSCLC histology * Myocardial Infarction within 6 months of study Day 1 * Use of proton-pump inhibitors (PPIs), histamine (H2) receptor antagonists (H2RA), strong inducers of cytochrome P450 (CYP) 3A4 (CYP3A4) or known CYP3A4 sensitive substrates or P-gp substrates * Therapeutic or palliative radiation therapy within 2 weeks of study day 1 * Unable to take oral medication * Unable to receive both iodinated contrast for computed tomography (CT) scans and gadolinium contrast for magnetic resonance imagine (MRI) scans

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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.

Non-small cell lung cancer

Contacts and locations

Locations

  • Alabama Oncology

    Birmingham, Alabama, 35243, United States

  • Allegheny Health Network Cancer Institute at Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Arizona Oncology Associates Professional Corporation

    Tucson, Arizona, 85711, United States

  • Asklepios - Fachkliniken München-Gauting

    Gauting, 82130, Germany

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga

    Orbassano (TO), 10043, Italy

  • Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi

    Naples, 80131, Italy

  • Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo

    Monza (MB), 20900, Italy

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207, United States

  • Centre Hospitalier Universitaire Régional de Lille - Hôpital Albert Calmette

    Lille, 59037, France

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

    Pessac, 33604, France

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 4000, Belgium

  • Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren

    Limoges, 87042, France

  • Centre Hospitalier Universitaire de Montpellier - Val d Aurelle

    Montpellier, 34298, France

  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

    Rennes, 35033, France

  • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

    Toulouse, 31059, France

  • Centre Hospitalier de Nantes - Hôpital Nord Laënnec

    Saint-Herblain, 44800, France

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • City of Hope at Long Beach Elm

    Duarte, California, 91010, United States

  • Duke University Medical Center, Morris Cancer Clinic

    Durham, North Carolina, 27710, United States

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631, United States

  • Frederick Memorial Hospital

    Frederick, Maryland, 21702, United States

  • Gavle Sjukhus

    Gävle, 801 87, Sweden

  • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

    Ankara, 06560, Turkey (Türkiye)

  • Gundersen Health System

    La Crosse, Wisconsin, 54601, United States

  • Hopital Cochin

    Paris, 75014, France

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, Galicia, 15706, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, Valencia, 46026, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041, Spain

  • Hospital del Mar

    Barcelona, Catalonia, 08003, Spain

  • Hôpital Sainte Musse

    Toulon, 83056, France

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Institut Sainte Catherine

    Avignon, 84918, France

  • Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano

    Rome, 00144, Italy

  • James J Peters VA Medical Center

    The Bronx, New York, 10468, United States

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, 3500, Belgium

  • Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main

    Frankfurt am Main, 60590, Germany

  • Koc Universitesi Hastanesi

    Istanbul, 34010, Turkey (Türkiye)

  • Laura and Isaac Perlmutter Cancer Center at New York University Langone

    New York, New York, 10016, United States

  • Medical University of South Carolina, Hollings Cancer Center

    Charleston, South Carolina, 29425, United States

  • Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis

    Amsterdam, 1066 CX, Netherlands

  • Norrlands Universitetssjukhus

    Umeå, 901 85, Sweden

  • Northport Veterans Affairs Medical Center

    Northport, New York, 11768, United States

  • Northwest Georgia Oncology Centers PC

    Marietta, Georgia, 30060, United States

  • Odense Universitetshospital

    Odense C, 5000, Denmark

  • Oncology Consultants PA

    Houston, Texas, 77030, United States

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45, Sweden

  • Skanes Universitetssjukhus

    Lund, 221 85, Sweden

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210, United States

  • Texas Oncology - Baylor

    Dallas, Texas, 75246, United States

  • Texas Oncology - Flower Mound

    Dallas, Texas, 75234, United States

  • Texas Oncology - Medical City Dallas

    Dallas, Texas, 75230-2510, United States

  • Texas Oncology - Northeast Texas

    Paris, Texas, 75460-5004, United States

  • Texas Oncology - Plano East

    Dallas, Texas, 75230-2510, United States

  • Texas Oncology- Mckinney

    McKinney, Texas, 75071, United States

  • Texas Oncology-Dallas Presbyterian Hospital

    Dallas, Texas, 75231, United States

  • Texas Oncology-Denton

    Denton, Texas, 76201, United States

  • Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

    Edirne, 22030, Turkey (Türkiye)

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650, Belgium

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    Brussels, 1200, Belgium

  • Universitetssjukhuset i Linkoping

    Linköping, 581 85, Sweden

  • University of Pittsburgh Medical Center Cancer Pavillion

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Universitätsklinikum Köln

    Cologne, 50937, Germany

More trials for these conditions

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