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A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)

NCT05920356•Amgen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

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

Locations (379)

Sansum Clinic

Santa Barbara, California, United States

Medical Oncology Hematology Consultants Helen F Graham Cancer Center

Newark, Delaware, United States

University of Illinois Chicago

Chicago, Illinois, United States

Illinois Cancer Specialists

Niles, Illinois, United States

Norton Cancer Institute - Brownsboro

Louisville, Kentucky, United States

Reliant Medical Group Inc

Worcester, Massachusetts, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University

Durham, North Carolina, United States

FirstHealth Cancer Center

Pinehurst, North Carolina, United States

Key Dates

Start Date

November 16, 2023

Primary Completion Date

June 30, 2026

Completion Date

June 30, 2031

Last Updated

February 27, 2026

Enrollment

750

ESTIMATED participants

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Interventions

Sotorasib

DRUG

Pembrolizumab

DRUG

Contacts

Amgen Call Center

CONTACT

866-572-6436 medinfo@amgen.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors

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