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)

ClinicalTrials.gov ID: NCT05920356

Public ClinicalTrials.gov record NCT05920356. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 17, 2026, 8:22 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05920356
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Amgen; Industry
Enrollment: 750 participants

Conditions and interventions

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Interventions

Sotorasib Drug
Pembrolizumab Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 100 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 16, 2023 (Actual)
Primary completion: Jun 30, 2027 (Estimated)
Completion: Jun 29, 2032 (Estimated)
Last update posted: Oct 13, 2026

2023 – 2032

United States locations

U.S. sites: 30
U.S. states: 16
U.S. cities: 28

Facility	City	State	ZIP	Site status
Sansum Clinic	Santa Barbara	California	93105	Recruiting
Medical Oncology Hematology Consultants Helen F Graham Cancer Center	Newark	Delaware	19713	Recruiting
Boca Raton Clinical Research Coral Springs	Coral Springs	Florida	33065	Recruiting
Regis Clinical Research LLC	Miami	Florida	33126	Recruiting
Florida Clinical Trials Group Plantation	Plantation	Florida	33322	Recruiting
Florida Clinical Trials Group Tamarac	Tamarac	Florida	33321	Recruiting
University of Illinois Chicago	Chicago	Illinois	60612	Recruiting
Illinois Cancer Specialists	Niles	Illinois	60714	Recruiting
Norton Cancer Institute - Brownsboro	Louisville	Kentucky	40241	Completed
Reliant Medical Group Inc	Worcester	Massachusetts	01606	Recruiting
University of New Mexico Cancer Center	Albuquerque	New Mexico	87131	Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	10065	Terminated
Messino Cancer Centers Asheville	Asheville	North Carolina	28806	Recruiting
Duke University Medical Center	Durham	North Carolina	27710	Recruiting
FirstHealth Cancer Center	Pinehurst	North Carolina	28374	Recruiting
Dayton Physician's Network	Dayton	Ohio	45415	Recruiting
Alliance Cancer Specialists - Media	Media	Pennsylvania	19063	Recruiting
University of Pittsburgh Medical Center Hillman Cancer Center	Pittsburgh	Pennsylvania	15232	Terminated
Guthrie Medical Group	Sayre	Pennsylvania	18840	Recruiting
Medical University of South Carolina	Florence	South Carolina	29505	Recruiting
Medical University of South Carolina Health Lancaster Medical Center	Lancaster	South Carolina	29720	Recruiting
University of Tennessee Medical Center Knoxville	Knoxville	Tennessee	37920	Terminated
Regional One Health	Memphis	Tennessee	38103	Recruiting
Sarah Cannon Research Institute	Nashville	Tennessee	37203	Recruiting
United States Oncology Regulatory Affairs Corporate Office	Nashville	Tennessee	37203	Recruiting
Oncology Consultants PA	Houston	Texas	77030	Recruiting
University of Texas MD Anderson Cancer Center	Houston	Texas	77030	Recruiting
US Oncology Research Investigational Products Center	Irving	Texas	75063	Recruiting
Vista Oncology Inc PS	Olympia	Washington	98506	Recruiting
Mercyhealth	Janesville	Wisconsin	53548	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 392 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05920356, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 13, 2026 · Synced Oct 17, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05920356 live on ClinicalTrials.gov.

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