The purpose of this expanded access program (EAP) is to provide early access to divarasib to participants with KRAS G12C-positive (KRAS G12C+) advanced or metastatic non-small cell lung cancer (NSCLC), prior to divarasib becoming commercially available in the United States.
Locally advanced or metastatic NSCLC not amenable to treatment with surgical resection or combined chemoradiation
Disease progression during or after treatment with at least one prior standard of care systemic therapy but no more than three lines of prior systemic therapy in the advanced or metastatic setting, with the exceptions for adjuvant/neoadjuvant therapies
Documentation of the presence of a KRAS G12C mutation obtained at any timepoint during the course of the disease
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Previous enrollment in Roche- or Genentech-sponsored study of divarasib
Prior treatment with a pan-KRAS/RAS inhibitor
Prior treatment with a KRAS G12C inhibitor, unless specific criteria are met
Pregnant or breastfeeding, or intending to become pregnant during the EAP or within the timeframe in which contraception is required
Divarasib
DrugParticipants will self-administer divarasib as per the schedule in the protocol.
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