Recruiting
Phase 3

Sotorasib vs. Pembrolizumab

Sponsor:

Amgen

Code:

NCT05920356

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Sotorasib

Pembrolizumab

Study Details

Brief summary:

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.

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Study ID

NCT05920356

Start date

Nov 16, 2023

Status verified date

Oct, 2026

Completion date

Jun 29, 2032

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

750 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sotorasib combined with carboplatin and pemetrexed

Sotorasib administered in combination with carboplatin and pemetrexed.

active comparator: Pembrolizumab combined with carboplatin and pemetrexed

Pembrolizumab administered in combination with carboplatin and pemetrexed.

Interventions

Sotorasib

Oral administration

Pembrolizumab

Intravenous administration

Primary outcome measure

  • Progression-free Survival (PFS) [ Time Frame: Approximately 2.5 years ]
  • Overall Survival (OS) [ Time Frame: Approximately 2.5 years ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

Sansum Clinic

Recruiting

Santa Barbara, California, United States, 93105

Medical Oncology Hematology Consultants Helen F Graham Cancer Center

Recruiting

Newark, Delaware, United States, 19713

Boca Raton Clinical Research Coral Springs

Recruiting

Coral Springs, Florida, United States, 33065

Regis Clinical Research LLC

Recruiting

Miami, Florida, United States, 33126

Florida Clinical Trials Group Plantation

Recruiting

Plantation, Florida, United States, 33322

Florida Clinical Trials Group Tamarac

Recruiting

Tamarac, Florida, United States, 33321

University of Illinois Chicago

Recruiting

Chicago, Illinois, United States, 60612

Illinois Cancer Specialists

Recruiting

Niles, Illinois, United States, 60714

Reliant Medical Group Inc

Recruiting

Worcester, Massachusetts, United States, 01606

University of New Mexico Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87131

Messino Cancer Centers Asheville

Recruiting

Asheville, North Carolina, United States, 28806

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

FirstHealth Cancer Center

Recruiting

Pinehurst, North Carolina, United States, 28374

Dayton Physician's Network

Recruiting

Dayton, Ohio, United States, 45415

Alliance Cancer Specialists - Media

Recruiting

Media, Pennsylvania, United States, 19063

Guthrie Medical Group

Recruiting

Sayre, Pennsylvania, United States, 18840

Medical University of South Carolina

Recruiting

Florence, South Carolina, United States, 29505

Medical University of South Carolina Health Lancaster Medical Center

Recruiting

Lancaster, South Carolina, United States, 29720

Regional One Health

Recruiting

Memphis, Tennessee, United States, 38103

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

United States Oncology Regulatory Affairs Corporate Office

Recruiting

Nashville, Tennessee, United States, 37203

Oncology Consultants PA

Recruiting

Houston, Texas, United States, 77030

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

US Oncology Research Investigational Products Center

Recruiting

Irving, Texas, United States, 75063

Vista Oncology Inc PS

Recruiting

Olympia, Washington, United States, 98506

Mercyhealth

Recruiting

Janesville, Wisconsin, United States, 53548

Queen Elizabeth II, Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 1V7

Sunnybrook Research Institute Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

McGill University Health Centre Glen Site

Recruiting

Montreal, Quebec, Canada, H4A 3J1

CIUSSS - du Nord-de-lIle-de-Montreal / Hopital Sacre-Coeur de Montreal

Recruiting

Montreal, Quebec, Canada, H4J 1C5

More Information

Sponsor

Amgen

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • Oncology
  • Lung Cancer
  • PD-L1
  • KRAS p.G12C
  • Sotorasib
  • Pembrolizumab
  • Carboplatin
  • Pemetrexed
  • CodeBreaK 202
  • NSCLC
  • PD-L1 Negative
  • AMG 510
  • LUMAKRAS ®
  • LUMYKRAS ®

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Amgen on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.