Histopathology confirmed unresectable locally advanced or metastatic NSCLC
Measurable disease per RECIST 1.1
Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)
ECOG PS=0 or 1
Adequate organ function
Received prior treatment with a platinum-based chemotherapy regimen and an immune checkpoint inhibitor in the advanced, non-resectable setting.
Have documented disease progression during or following their most recent prior line of therapy.
Patients with 2L/3L on stable or preferred dose:
Received at least 1 and no more than 2 prior systemic lines of therapy for advanced (in the unresectable locally advanced or metastatic setting) NSCLC.
Patients with 2L-4L with brain metastases:
Received at least 1 and no more than 3 prior systemic lines of therapy for advanced (in the unresectable locally advanced or metastatic setting) NSCLC.
Have asymptomatic and untreated brain metastases
At least 1 untreated measurable brain lesion per mRECIST v1.1 with a long axis ≥ 0.5 cm and ≤ 3 cm.
You may not be if
Have any other documented co-existing common RAS mutation(s)
Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter
Major surgery within 4 weeks of first treatment dose
Radiation therapy (RT) within 1 week of first treatment dose
History of drug-induced Interstitial Lung Disease
Receipt of prior direct RAS inhibitor
Untreated or symptomatic CNS metastasis
Receipt of strong CYP3A4 inhibitor/inducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter
Receipt of PPI or H2 blocker within 5 days
Inability to swallow oral medication
Clareo Health | A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Non-Small Cell Lung Cancer
