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)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorAmgen

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Sotorasib
  • Pembrolizumab

Treatment groups

750 Participants
are divided into 2 treatment groups

Locations

383
Argentina
Hospital Britanico de Buenos AiresC1280AEB, CABABuenos Aires, Argentina
Instituto Alexander FlemingC1426ANZ, Capital FederalBuenos Aires, Argentina
Instituto Argentino de Diagnostico y Tratamiento IADTC1012AAR, Ciudad Autónoma de Buenos AiresBuenos Aires, Argentina
Hospital Italiano de La PlataB1900AUR, La PlataBuenos Aires, Argentina

Sponsors and collaborators

Amgen

Lead sponsor