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)

Sponsor: Amgen

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05920356

Patient View

This clinical trial evaluates progression-free survival in patients with advanced nonsquamous NSCLC with KRAS p.G12C mutation and negative PD-L1 expression. Eligible participants have not received prior systemic therapy in metastatic settings and have an ECOG score ≤ 1. The study compares oral sotorasib with intravenous pembrolizumab, both combined with platinum doublet chemotherapy.

Patient Parameters

Program Overview

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.

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
  • 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

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