Overview

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)

Status:
Recruiting
Trial end date:
2031-03-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Treatments:
Pembrolizumab
Sotorasib
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

- 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