A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).

Eligibility criteria

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Histologically or cytologically confirmed diagnosis of advanced or metastatic non squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy

Measurable disease, as defined by RECIST v1.1

No prior systemic treatment for advanced or metastatic NSCLC

Disqualifiers

Known concomitant second oncogenic driver with available targeted treatment

Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases

Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks prior to randomization

History of leptomeningeal disease

Trial design

Treatments tested in this trial

  • Divarasib
  • Pembrolizumab
  • Pemetrexed
  • Carboplatin
  • Cisplatin

Treatment groups

600 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hoffmann-La Roche

Lead sponsor

Chugai Pharmaceutical

Collaborator