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

NCT04933695 | Completed Phase 2 FDA Drug

• 2 other identifiers: 201902882021-002638-18
• Study Type: interventional
• Target: 42
• Locations: 10 countries
• Sites: 67

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer; KRAS p.G12C; Sotorasib; AMG 510

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (OR)

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

  Up to 6 years

Secondary Outcomes (13)

• Disease Control Rate

  Up to 6 years

• Duration of Reponse (DOR)

  Up to 6 years

• Time to Response (TTR)

  Up to 6 years

• Progression-free Survival (PFS)

  Up to 6 years

• Overall Survival (OS)

  Up to 6 years

Study Arms (2)

Sotorasib: 960 mg Daily

EXPERIMENTAL

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

Sotorasib: 240 mg Daily

EXPERIMENTAL

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

Interventions

Sotorasib DRUG

Oral tablet

Also known as: AMG 510, LUMYKRAS, LUMAKRAS

Sotorasib: 240 mg Daily; Sotorasib: 960 mg Daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (67)

Alabama Oncology

Birmingham, Alabama, 35243, United States

Location

Arizona Oncology Associates Professional Corporation

Tucson, Arizona, 85711, United States

Location

City of Hope at Long Beach Elm

Duarte, California, 91010, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

Location

Northwest Georgia Oncology Centers PC

Marietta, Georgia, 30060, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Frederick Memorial Hospital

Frederick, Maryland, 21702, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Laura and Isaac Perlmutter Cancer Center at New York University Langone

New York, New York, 10016, United States

Location

Northport Veterans Affairs Medical Center

Northport, New York, 11768, United States

Location

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

Location

James J Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

Duke University Medical Center, Morris Cancer Clinic

Durham, North Carolina, 27710, United States

Location

Allegheny Health Network Cancer Institute at Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center Cancer Pavillion

Pittsburgh, Pennsylvania, 15232, United States

Location

Medical University of South Carolina, Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

Texas Oncology - Medical City Dallas

Dallas, Texas, 75230-2510, United States

Location

Texas Oncology - Plano East

Dallas, Texas, 75230-2510, United States

Location

Texas Oncology-Dallas Presbyterian Hospital

Dallas, Texas, 75231, United States

Location

Texas Oncology - Flower Mound

Dallas, Texas, 75234, United States

Location

Texas Oncology - Baylor

Dallas, Texas, 75246, United States

Location

Texas Oncology-Denton

Denton, Texas, 76201, United States

Location

Oncology Consultants PA

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Texas Oncology- Mckinney

McKinney, Texas, 75071, United States

Location

Texas Oncology - Northeast Texas

Paris, Texas, 75460-5004, United States

Location

Gundersen Health System

La Crosse, Wisconsin, 54601, United States

Location

Universite Catholique de Louvain Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, 3500, Belgium

Location

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, 4000, Belgium

Location

Odense Universitetshospital

Odense C, 5000, Denmark

Location

Institut Sainte Catherine

Avignon, 84918, France

Location

Centre Hospitalier Universitaire Régional de Lille - Hôpital Albert Calmette

Lille, 59037, France

Location

Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren

Limoges, 87042, France

Location

Centre Hospitalier Universitaire de Montpellier - Val d Aurelle

Montpellier, 34298, France

Location

Hopital Cochin

Paris, 75014, France

Location

Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

Pessac, 33604, France

Location

Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

Rennes, 35033, France

Location

Centre Hospitalier de Nantes - Hôpital Nord Laënnec

Saint-Herblain, 44800, France

Location

Hôpital Sainte Musse

Toulon, 83056, France

Location

Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

Toulouse, 31059, France

Location

Universitätsklinikum Köln

Cologne, 50937, Germany

Location

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

Frankfurt am Main, 60590, Germany

Location

Asklepios - Fachkliniken München-Gauting

Gauting, 82130, Germany

Location

Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo

Monza (MB), 20900, Italy

Location

Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi

Napoli, 80131, Italy

Location

Azienda Ospedaliera Universitaria San Luigi Gonzaga

Orbassano (TO), 10043, Italy

Location

Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano

Rome, 00144, Italy

Location

Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis

Amsterdam, 1066 CX, Netherlands

Location

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08041, Spain

Location

Hospital Clinico Universitario de Santiago

Santiago de Compostela, Galicia, 15706, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Gavle Sjukhus

Gävle, 801 87, Sweden

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, 413 45, Sweden

Location

Universitetssjukhuset i Linkoping

Linköping, 581 85, Sweden

Location

Skanes Universitetssjukhus

Lund, 221 85, Sweden

Location

Norrlands Universitetssjukhus

Umeå, 901 85, Sweden

Location

Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

Ankara, 06560, Turkey (Türkiye)

Location

Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

Edirne, 22030, Turkey (Türkiye)

Location

Koc Universitesi Hastanesi

Istanbul, 34010, Turkey (Türkiye)

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sotorasib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 22, 2021
• Study Start: January 28, 2022
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

DK (1); TU (3); ES (6); NL (1); US (30); DE (3); BE (4); FR (10); SE (5); IT (4)