AICHI CANCER CENTER

A multi-center, open-label, randomized clinical trial at five Nagoya hospitals (Feb 2024-Dec 2026) aims to assess the efficacy of PER in preventing seizures post-craniotomy for brain tumors. Inclusion criteria include patients aged 18-80 with supratentorial brain tumors, Karnofsky Performance Scale >70, no history of seizures, and written consent. Exclusion criteria cover patients unable to take tablets orally, those indicated for awake surgery, and others with specific CNS histories. The trial protocol adheres to SPIRIT guidelines, with ethical approval from Nagoya University Hospital. The primary outcome is seizure incidence within 28 days postoperatively, with secondary outcomes including hospital and ICU stays, and postoperative complications. Data will be managed using REDCap, with a one-sided significance level of 0.05 for primary endpoint analysis.

Olomorasib (50 or 100 mg) plus pembrolizumab showed 77% ORR in KRAS G12C-mutated metastatic NSCLC, regardless of PD-L1 expression, in the phase 1/2 LOXO-RAS-20001 study. Median time to response was 1.4 months, with 88% and 81% disease control rates in respective cohorts. AEs included diarrhea, fatigue, and increased ALT levels. A global registrational trial, SUNRAY-01, is ongoing.