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)

Amgen

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

Age range: 18–100 years
Sex: All
Healthy volunteers: No

Detailed 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…

Locations (420)

Sansum Clinic
Santa Barbara, California
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark, Delaware
Boca Raton Clinical Research Coral Springs
Coral Springs, Florida
Florida Clinical Trials Group Plantation
Plantation, Florida
Florida Clinical Trials Group Tamarac
Tamarac, Florida
University of Illinois Chicago
Chicago, Illinois

Summary

Eligibility

Interventions

Locations (420)