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)

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSotorasib and Pembrolizumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 23, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 3

Interventional

Where is it offered?424 U.S. locations

Locations may change over time.

Who runs it?Amgen

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 3
Sponsor: Amgen
Interventions being studied: Drug: Sotorasib; Drug: Pembrolizumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Treatment approach

Immunotherapy→Targeted therapy→Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Sansum ClinicSanta Barbara, California
Medical Oncology Hematology Consultants Helen F Graham Cancer CenterNewark, Delaware
Boca Raton Clinical Research Coral SpringsCoral Springs, Florida
Regis Clinical Research LLCMiami, Florida
Florida Clinical Trials Group PlantationPlantation, Florida
Florida Clinical Trials Group TamaracTamarac, Florida
University of Illinois ChicagoChicago, Illinois
Illinois Cancer SpecialistsNiles, Illinois
Norton Cancer Institute - BrownsboroLouisville, Kentucky
Reliant Medical Group IncWorcester, Massachusetts
University of New Mexico Cancer CenterAlbuquerque, New Mexico
Memorial Sloan Kettering Cancer CenterNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 23, 2026. Always confirm current availability with the study team.

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