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Recruiting NCT05920356

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)

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 750
Sponsor: Amgen

Location: Sansum Clinic Santa Barbara California

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 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05920356). StuddyBuddy aggregates publicly available trial information.