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RecruitingPhase 3NCT05920356

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)

For people newly diagnosed with advanced non-squamous lung cancer that carries a KRAS G12C mutation, this study compares sotorasib plus chemotherapy against pembrolizumab plus chemotherapy. It measures how long the cancer stays controlled and how long people live.

SponsorAmgen
Study typeInterventional
Started2023-11-16
Primary completion2027-06-30
Planned enrolment750
Sites1 Acıbadem · 417 other

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)

What this study is about

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.

Conditions
  • Non-Small Cell Lung Cancer (NSCLC)
Interventions
  • Sotorasib
  • Pembrolizumab
Primary outcome measures
  • Progression-free Survival (PFS) — Approximately 2.5 years
  • Overall Survival (OS) — Approximately 2.5 years
Who can take part
SexAllAge18 Years to 100 YearsHealthy volunteersNo
Inclusion
* 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
* 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

Criteria are written for physicians. Do not rule yourself out: send your reports and the study team will check.

Acıbadem study sites
  • Acıbadem Maslak Hastanesi, IstanbulRecruiting

Also running at 417 other sites in 38 countries.

Source: ClinicalTrials.gov NCT05920356 · last updated 2026-09-22 · View registry record ↗

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