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CodeBreaK201: 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

Sponsor
Amgen (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04933695
Collaborator
(none)
170
Enrollment
65
Locations
2
Arms
77
Anticipated Duration (Months)
2.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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 (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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
170 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jan 28, 2022
Anticipated Primary Completion Date :
Dec 29, 2023
Anticipated Study Completion Date :
Jun 28, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sotorasib: 960 mg Daily

Participants 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.

Drug: Sotorasib
Oral tablet
Other Names:
  • AMG 510
  • LUMYKRAS
  • LUMAKRAS

    		•
    Experimental: Sotorasib: 240 mg Daily

    Participants 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.

    Drug: Sotorasib
    Oral tablet
    Other Names:
  • AMG 510
  • LUMYKRAS
  • LUMAKRAS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (OR) [Up to 6 years]

      OR is defined as the total of Complete Response (CR) and Partial Response (PR).

    Secondary Outcome Measures

    1. Disease Control Rate [Up to 6 years]

    2. Duration of Reponse (DOR) [Up to 6 years]

    3. Time to Response (TTR) [Up to 6 years]

    4. Progression-free Survival (PFS) [Up to 6 years]

    5. Overall Survival (OS) [Up to 6 years]

    6. Number of Participants with a Treatment-emergent Adverse Event (TEAE) [Day 1 up to Month 13]

    7. Number of Participants with a Treatment-related Adverse Event [Day 1 up to Month 13]

    8. Number of Participants with a Clinically Significant Change from Baseline in Vital Signs [Baseline (Screening; up to 28 days pre-dose) up to Month 13]

    9. Number of Participants with a Clinically Significant Change from Baseline in Electrocardiograms (ECGs) [Baseline (Screening; up to 28 days pre-dose) up to Month 13]

    10. Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests [Baseline (Screening; up to 28 days pre-dose) up to Month 13]

    11. Maximum Plasma Concentration (Cmax) of Sotorasib [Day 1 up to Month 3]

    12. Time to Reach Maximum Plasma Concentration (tmax) of Sotorasib [Day 1 up to Month 3]

    13. Area Under the Plasma Concentration-time Curve (AUC) of Sotorasib [Day 1 up to Month 3]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alabama Oncology Birmingham Alabama United States 35243
    2 Arizona Oncology Associates Professional Corporation Tucson Arizona United States 85711
    3 City of Hope at Long Beach Elm Duarte California United States 91010
    4 City of Hope National Medical Center Duarte California United States 91010
    5 Baptist MD Anderson Cancer Center Jacksonville Florida United States 32207
    6 Northwest Georgia Oncology Centers PC Marietta Georgia United States 30060
    7 Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202
    8 Baptist Health Lexington Lexington Kentucky United States 40503
    9 Frederick Memorial Hospital Frederick Maryland United States 21702
    10 Englewood Hospital and Medical Center Englewood New Jersey United States 07631
    11 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08901
    12 James J Peters VA Medical Center Bronx New York United States 10468
    13 Laura and Isaac Perlmutter Cancer Center at New York University Langone New York New York United States 10016
    14 Northport Veterans Affairs Medical Center Northport New York United States 11768
    15 State University of New York Upstate Medical University Syracuse New York United States 13210
    16 Duke University Medical Center, Morris Cancer Clinic Durham North Carolina United States 27710
    17 Allegheny Health Network Cancer Institute at Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    18 University of Pittsburgh Medical Center Cancer Pavillion Pittsburgh Pennsylvania United States 15232
    19 Medical University of South Carolina, Hollings Cancer Center Charleston South Carolina United States 29425
    20 Texas Oncology - Medical City Dallas Dallas Texas United States 75230-2510
    21 Texas Oncology - Plano East Dallas Texas United States 75230-2510
    22 Texas Oncology-Dallas Presbyterian Hospital Dallas Texas United States 75231
    23 Texas Oncology - Flower Mound Dallas Texas United States 75234
    24 Texas Oncology Baylor Dallas Texas United States 75246
    25 Texas Oncology-Denton Denton Texas United States 76201
    26 Oncology Consultants PA Houston Texas United States 77030
    27 Texas Oncology- Mckinney McKinney Texas United States 75071
    28 Texas Oncology - Northeast Texas Paris Texas United States 75460-5004
    29 Gundersen Health System La Crosse Wisconsin United States 54601
    30 Universite Catholique de Louvain Cliniques Universitaires Saint Luc Bruxelles Belgium 1200
    31 Universitair Ziekenhuis Antwerpen Edegem Belgium 2650
    32 Jessa Ziekenhuis - Campus Virga Jesse Hasselt Belgium 3500
    33 Centre Hospitalier Universitaire de Liege - Sart Tilman Liege Belgium 4000
    34 Odense Universitetshospital Odense C Denmark 5000
    35 Institut Sainte Catherine Avignon cedex 9 France 84918
    36 Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren Limoges Cedex France 87042
    37 Centre Hospitalier Universitaire de Montpellier - Val d Aurelle Montpellier Cedex 5 France 34298
    38 Hopital Cochin Paris France 75014
    39 Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque Pessac Cedex France 33604
    40 Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou Rennes France 35033
    41 Centre Hospitalier de Nantes - Hôpital Nord Laënnec Saint Herblain France 44800
    42 Hôpital Sainte Musse Toulon Cedex France 83056
    43 Centre Hospitalier Universitaire de Toulouse - Hopital Larrey Toulouse Cedex 9 France 31059
    44 Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main Frankfurt am Main Germany 60590
    45 Asklepios - Fachkliniken München-Gauting Gauting Germany 82130
    46 Universitätsklinikum Köln Köln Germany 50937
    47 Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo Monza (MB) Italy 20900
    48 Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi Napoli Italy 80131
    49 Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano (TO) Italy 10043
    50 Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano Rome Italy 00144
    51 Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis Amsterdam Netherlands 1066 CX
    52 Hospital del Mar Barcelona Cataluña Spain 08003
    53 Hospital de la Santa Creu i Sant Pau Barcelona Cataluña Spain 08041
    54 Hospital Universitari i Politecnic La Fe Valencia Comunidad Valenciana Spain 46026
    55 Hospital Clinico Universitario de Santiago Santiago de Compostela Galicia Spain 15706
    56 Hospital Universitario Puerta de Hierro Majadahonda Majadahonda Madrid Spain 28222
    57 Hospital Universitario La Paz Madrid Spain 28046
    58 Gavle Sjukhus Gavle Sweden 801 87
    59 Sahlgrenska Universitetssjukhuset Goteborg Sweden 413 45
    60 Universitetssjukhuset i Linkoping Linkoping Sweden 581 85
    61 Skanes Universitetssjukhus Lund Sweden 221 85
    62 Norrlands Universitetssjukhus Umea Sweden 901 85
    63 Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi Ankara Turkey 06560
    64 Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi Edirne Turkey 22030
    65 Koc Universitesi Hastanesi Istanbul Turkey 34010

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT04933695
    Other Study ID Numbers:
    • 20190288
    • 2021-002638-18
    First Posted:
    Jun 22, 2021
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amgen
    Non-small cell lung cancer
    KRAS p.G12C
    Sotorasib
    AMG 510
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Aug 12, 2022