A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC)
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CONTACT
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Histological or cytological diagnosis of clinical Stage II-IIIB NSCLC of either non-squamous or squamous histology
Participants must have had complete resection of NSCLC
Prior treatment with neoadjuvant immune checkpoint inhibitor (pembrolizumab or nivolumab) in combination with histology-based platinum-based doublet chemotherapy
Participants must be randomized within 12 weeks of their surgery date
No evidence of disease recurrence or metastatic disease
Documentation of the presence of a KRAS G12C mutation
You may not be if
Participants who achieve pCR following neoadjuvant treatment
Prior treatment with a KRAS inhibitor or any other anti-cancer therapy not otherwise specified in the protocol
Prior treatment with radiation therapy for NSCLC, with the exception of localized symptom-directed radiation prior to surgical resection
Resolved Grade 3 or greater immune-related AE or unresolved Grade 2 or greater immune-related AE from neoadjuvant immunotherapy
Active or history of autoimmune disease or immune deficiency
