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Non-small Cell Lung CancerPhase 2CodeBreaK201NCT04933695

A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment

A Phase 2 study testing Sotorasib in people with Non-small Cell Lung Cancer, run by Amgen at 67 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Sotorasib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
67 sitesin 10 countries
Study dates
28 Jan 2022to 28 May 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

67 sites in 10 countries.

67 sites in 10 countries

United States30 sites

  • Alabama Oncology

    Birmingham, Alabama, 35243

  • Medical University of South Carolina, Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Texas Oncology - Medical City Dallas

    Dallas, Texas, 75230-2510

  • Texas Oncology - Plano East

    Dallas, Texas, 75230-2510

  • Texas Oncology-Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • Texas Oncology - Flower Mound

    Dallas, Texas, 75234

  • Texas Oncology - Baylor

    Dallas, Texas, 75246

  • Texas Oncology-Denton

    Denton, Texas, 76201

  • City of Hope at Long Beach Elm

    Duarte, California, 91010

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Duke University Medical Center, Morris Cancer Clinic

    Durham, North Carolina, 27710

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Frederick Memorial Hospital

    Frederick, Maryland, 21702

  • Oncology Consultants PA

    Houston, Texas, 77030

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Gundersen Health System

    La Crosse, Wisconsin, 54601

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Northwest Georgia Oncology Centers PC

    Marietta, Georgia, 30060

  • Texas Oncology- Mckinney

    McKinney, Texas, 75071

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

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

    New York, New York, 10016

  • Northport Veterans Affairs Medical Center

    Northport, New York, 11768

  • Texas Oncology - Northeast Texas

    Paris, Texas, 75460-5004

  • Allegheny Health Network Cancer Institute at Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Medical Center Cancer Pavillion

    Pittsburgh, Pennsylvania, 15232

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • James J Peters VA Medical Center

    The Bronx, New York, 10468

  • Arizona Oncology Associates Professional Corporation

    Tucson, Arizona, 85711

Other trials in United States

France10 sites

  • Institut Sainte Catherine

    Avignon, 84918

  • Centre Hospitalier Universitaire Régional de Lille - Hôpital Albert Calmette

    Lille, 59037

  • Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren

    Limoges, 87042

  • Centre Hospitalier Universitaire de Montpellier - Val d Aurelle

    Montpellier, 34298

  • Hopital Cochin

    Paris, 75014

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

    Pessac, 33604

  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

    Rennes, 35033

  • Centre Hospitalier de Nantes - Hôpital Nord Laënnec

    Saint-Herblain, 44800

  • Hôpital Sainte Musse

    Toulon, 83056

  • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

    Toulouse, 31059

Other trials in France

Spain6 sites

  • Hospital del Mar

    Barcelona, Catalonia, 08003

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, Galicia, 15706

  • Hospital Universitari i Politecnic La Fe

    Valencia, Valencia, 46026

Other trials in Spain

Sweden5 sites

  • Gavle Sjukhus

    Gävle, 801 87

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

  • Universitetssjukhuset i Linkoping

    Linköping, 581 85

  • Skanes Universitetssjukhus

    Lund, 221 85

  • Norrlands Universitetssjukhus

    Umeå, 901 85

Other trials in Sweden

Belgium4 sites

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, 3500

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 4000

Other trials in Belgium

Italy4 sites

  • Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo

    Monza (MB), 20900

  • Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi

    Naples, 80131

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga

    Orbassano (TO), 10043

  • Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano

    Rome, 00144

Other trials in Italy

Germany3 sites

  • Universitätsklinikum Köln

    Cologne, 50937

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

    Frankfurt am Main, 60590

  • Asklepios - Fachkliniken München-Gauting

    Gauting, 82130

Other trials in Germany

Turkey (Türkiye)3 sites

  • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

    Ankara, 06560

  • Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

    Edirne, 22030

  • Koc Universitesi Hastanesi

    Istanbul, 34010

Other trials in Turkey (Türkiye)

Denmark1 site

  • Odense Universitetshospital

    Odense C, 5000

Other trials in Denmark

Netherlands1 site

  • Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis

    Amsterdam, 1066 CX

Other trials in Netherlands

About this study

Official title: A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects With Stage IV NSCLC Whose Tumors Harbor a KRAS G12C Mutation in Need of First-line Treatment (CodeBreaK 201)

The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) < 1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of participants with PD-L1 < 1% and in a subgroup of participants with STK11 co-mutation.

Being tested
Sotorasib
Keywords
Non-small cell lung cancer, KRAS p.G12C, Sotorasib, AMG 510
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.

  • SotorasibDrug

    Also called AMG 510, LUMYKRAS, LUMAKRAS

    Oral tablet

Study groups in NCT04933695
Study groupRoleWhat they receive
Sotorasib: 960 mg DailyExperimentalParticipants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express < 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 960 mg daily. Participants will be stratified by known presence of STK11 mutation.
Receives: Drug: Sotorasib
Sotorasib: 240 mg DailyExperimentalParticipants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express < 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 240 mg daily. Participants will be stratified by known presence of STK11 mutation.
Receives: Drug: Sotorasib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)

    Objective response was defined as best overall response (BOR) of complete response (CR) or partial response (PR), as defined by RECIST 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis <10 mm. PR was defined as at least a 30% decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Responses were assessed based on BICR.

    Measured: From the first dose of trial drug until min (last dose + 30 days, end of trial [EOT]); median [min, max] duration was 5.32 [0.8, 30.9] months

Secondary outcomes (7)

  1. Disease Control Rate (DCR) Per RECIST Version 1.1 as Assessed by BICR

    DCR was defined as the percentage of participants with an OR or stable disease (SD) per RECIST v1.1. CR: disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study).

    Measured: From randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months

  2. Duration of Response (DOR) Per RECIST Version 1.1 as Assessed by BICR

    DOR was defined as time from the first documentation of OR subsequently confirmed until the first documentation of PD or death due to any cause, whichever comes first. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (target or non-target) must have a reduction in their short axis <10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

    Measured: From randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months

  3. Time to Response (TTR) Per RECIST Version 1.1 as Assessed by BICR

    TTR was defined as time from first dose date to the first documentation of PR or CR subsequently confirmed. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

    Measured: From randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months

  4. Progression-free Survival (PFS) as Assessed by BICR

    PFS by BICR was defined as the time from first dose date to disease progression or death due to any cause (whichever comes first). PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the baseline SOD of target lesions.

    Measured: From randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months

  5. Overall Survival (OS)

    OS was defined as the time from first dose date until event of death due to any cause.

    Measured: From randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months

  6. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-related TEAEs

    TEAEs are AEs starting on or after the first dose of sotorasib as determined by the flag indicating if the AE started prior to the first dose on the Events case report form (CRF) and up to and including 30 days after the last dose of sotorasib or the EOT date, whichever is earlier. A treatment-related TEAE is any TEAE with the relationship flag on the events CRF indicating there is a reasonable possibility that the event may have been caused by investigational medicinal product. Clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests were included as TEAEs.

    Measured: From the first dose of trial drug until min (last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months

  7. Plasma Concentration of Sotorasib

    Blood samples were collected at specified timepoints.

    Measured: Cycles 1 and 2: Day 1 pre-dose and 1 hour post-dose; Cycles 3, 4 and, 5: Day 1 pre-dose (cycle length = 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2021
  2. Study start28 Jan 2022
  3. Primary completion28 May 2025
  4. Study completion28 May 2025

Why it stopped: Futility

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04933695
Sponsor's protocol ID
20190288
Other IDs
2021-002638-18
Acronym
CodeBreaK201
Status last verified
Jun 2026
First submitted
14 Jun 2021
Last updated
13 Jul 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sotorasib in people with Non-small Cell Lung Cancer, run by Amgen at 67 sites in 10 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 7 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: stopped early, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, France, Spain, Sweden, Belgium and 5 more countries. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR) (time frame: From the first dose of trial drug until min (last dose + 30 days, end of trial [EOT]); median [min, max] duration was 5.32 [0.8, 30.9] months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04933695.

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 13 Jul 2026.

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