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Purpose

The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

Condition

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing - No history of systemic anticancer therapy in metastatic/non-curable settings - Eastern Cooperative Oncology Group (ECOG) ≤ 1

Exclusion Criteria

  • Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology - Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy - Symptomatic (treated or untreated) brain metastases - Gastrointestinal (GI) tract disease causing the inability to take oral medication - Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina - Prior therapy with a KRAS G12C inhibitor

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Sotorasib combined with carboplatin and pemetrexed 		Sotorasib administered in combination with carboplatin and pemetrexed.
  • Drug: Sotorasib
    Oral administration
    Other names:
    • AMG 510
    • LUMYKRAS ®
    • LUMAKRAS ®
Active Comparator
Pembrolizumab combined with carboplatin and pemetrexed 		Pembrolizumab administered in combination with carboplatin and pemetrexed.
  • Drug: Pembrolizumab
    Intravenous administration

Recruiting Locations

Sansum Clinic
Santa Barbara, California 93105

Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark, Delaware 19713

University of Illinois Chicago
Chicago, Illinois 60612

Illinois Cancer Specialists
Niles, Illinois 60714

Reliant Medical Group Inc
Worcester, Massachusetts 01606

University of New Mexico Cancer Center
Albuquerque, New Mexico 87131

Messino Cancer Centers Asheville
Asheville, North Carolina 28806

Duke University Medical Center
Durham, North Carolina 27710

FirstHealth Cancer Center
Pinehurst, North Carolina 28374

Alliance Cancer Specialists - Media
Media, Pennsylvania 19063

Regional One Health
Memphis, Tennessee 38103

Sarah Cannon Research Institute
Nashville, Tennessee 37203

United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee 37203

Oncology Consultants PA
Houston, Texas 77030

University of Texas MD Anderson Cancer Center
Houston, Texas 77030

US Oncology Research Investigational Products Center
Irving, Texas 75063

Vista Oncology Inc PS
Olympia, Washington 98506

Mercyhealth
Janesville, Wisconsin 53548

Pan American Center for Oncology Trials
Ponce, Puerto Rico 00730

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.