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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)

NCT05920356

RecruitingPhase 3

Sponsor: Amgen

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Interventions: Sotorasib, Pembrolizumab

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

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 overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 (403)

Santa Barbara, California, United States
Newark, Delaware, United States
Chicago, Illinois, United States
Niles, Illinois, United States
Louisville, Kentucky, United States
Worcester, Massachusetts, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Asheville, North Carolina, United States
Durham, North Carolina, United States
Pinehurst, North Carolina, United States
Dayton, Ohio, United States
Media, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Olympia, Washington, United States
Janesville, Wisconsin, United States
CABA, Buenos Aires, Argentina
Capital Federal, Buenos Aires, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
San Salvador de Jujuy, Jujuy Province, Argentina
Viedma, Río Negro Province, Argentina
Rosario, Santa Fe Province, Argentina
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