The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).
Confirmation of Biomarker eligibility
Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Histologically or cytologically documented locally advanced unresectable or metastatic NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
Known concomitant second oncogenic driver with available targeted treatment
Squamous cell histology NSCLC
Symptomatic, untreated, or actively progressing CNS metastases (Cohorts A, B, and C)
Prior treatment with a KRAS G12C inhibitor
Hoffmann-La Roche
Lead sponsor