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)

NCT05920356 · tracked via the Priya Life Science USA tracker

Sponsor

Amgen

Phase

Phase 3

Started

2023-11-16

Last updated

2026-09-11

Condition(s) studied

Non-Small Cell Lung Cancer (NSCLC)

Investigational drug(s) / intervention(s)

SotorasibPembrolizumab

Sotorasib: Oral administration

Pembrolizumab: Intravenous administration

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

100 Years

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

Primary outcome measure(s)

Progression-free Survival (PFS) — Approximately 2.5 years
PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, per Blinded Independent Central Review (BICR).
Overall Survival (OS) — Approximately 2.5 years
OS is defined as the time from randomization until death due to any cause.

Trial sites (418)

Facility	City	Region	Status
Sansum Clinic	Santa Barbara	California	Recruiting
Medical Oncology Hematology Consultants Helen F Graham Cancer Center	Newark	Delaware	Recruiting
Boca Raton Clinical Research Coral Springs	Coral Springs	Florida	Recruiting
Florida Clinical Trials Group Plantation	Plantation	Florida	Recruiting
Florida Clinical Trials Group Tamarac	Tamarac	Florida	Recruiting
University of Illinois Chicago	Chicago	Illinois	Recruiting
Illinois Cancer Specialists	Niles	Illinois	Recruiting
Norton Cancer Institute - Brownsboro	Louisville	Kentucky	Completed
Reliant Medical Group Inc	Worcester	Massachusetts	Recruiting
University of New Mexico Cancer Center	Albuquerque	New Mexico	Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	Terminated
Messino Cancer Centers Asheville	Asheville	North Carolina	Recruiting
Duke University Medical Center	Durham	North Carolina	Recruiting
FirstHealth Cancer Center	Pinehurst	North Carolina	Recruiting
Dayton Physician's Network	Dayton	Ohio	Recruiting
Alliance Cancer Specialists - Media	Media	Pennsylvania	Recruiting
University of Pittsburgh Medical Center Hillman Cancer Center	Pittsburgh	Pennsylvania	Terminated
Guthrie Medical Group	Sayre	Pennsylvania	Recruiting
University of Tennessee Medical Center Knoxville	Knoxville	Tennessee	Terminated
Regional One Health	Memphis	Tennessee	Recruiting
Sarah Cannon Research Institute	Nashville	Tennessee	Recruiting
United States Oncology Regulatory Affairs Corporate Office	Nashville	Tennessee	Recruiting
Oncology Consultants PA	Houston	Texas	Recruiting
University of Texas MD Anderson Cancer Center	Houston	Texas	Recruiting
US Oncology Research Investigational Products Center	Irving	Texas	Recruiting
Vista Oncology Inc PS	Olympia	Washington	Recruiting
Mercyhealth	Janesville	Wisconsin	Recruiting
Hospital Britanico de Buenos Aires	CABA	Buenos Aires	Terminated
Instituto Alexander Fleming	Capital Federal	Buenos Aires	Recruiting
Instituto Argentino de Diagnostico y Tratamiento IADT	Ciudad Autónoma de Buenos Aires	Buenos Aires	Recruiting
Hospital Italiano de La Plata	La Plata	Buenos Aires	Recruiting
Fundacion Ars Medica	San Salvador de Jujuy	Jujuy Province	Terminated
Clinica Viedma	Viedma	Río Negro Province	Recruiting
Fundacion Estudios Clinicos	Rosario	Santa Fe Province	Recruiting
Sanatorio Parque SA	Rosario	Santa Fe Province	Recruiting
Centro Oncologico Korben	Buenos Aires	Argentina	Recruiting
Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer	La Rioja	Argentina	Terminated
Centro de Diagnostico Investigacion y Tratamiento	Salta	Argentina	Recruiting
Campbelltown Hospital	Campbelltown	New South Wales	Recruiting
Concord Repatriation General Hospital	Concord	New South Wales	Recruiting

+ 378 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05920356 on ClinicalTrials.gov ↗ ← All trials in the USA