Studieoverzicht

Study name: INCLUSION ON HOLD: RAMP VS-6766-203

Histology	NSCLC
Tumor stage	Stage I - III, Stage IV
Host / recruiting sites	Erasmus MC, LUMC
Enrollment	Recruiting
Therapy line	Later line (≥2L)
Design	RAMP VS-6766-203 A Phase 1/2 Study of Avutometinib (VS-6766) in Combination with Sotorasib in Patients with KRAS G12C mutant Non-Small Cell Lung Cancer
Intervention	Part A: dose evaluation phase: open label Part B: dose expansion phase: open label; 2 cohorts
Key outcome parameters	Part A: to determine the optimal combination dose for Avutometinib in combination with Sotorasib. Part B: to determine the efficacy of the optimal combination dose
Key inclusion criteria	Metastatic or locally advanced and unresectable NSCLC, with KRAS G12C mutation The patient must have received, in any setting, anti-programmed cell death protein 1 or anti-programmed death-ligand 1 immunotherapy AND/OR platinum-based combination chemotherapy; AND targeted therapy for actionable oncogenic driver mutations ECOG performance status ≤ 1.
Key exclusion criteria	History of treatment with a direct and specific inhibitor of MEK. Part A: Leptomeningeal metastases or any central nervous system (CNS) metastases. Part B: Leptomeningeal metastases. Any active CNS metastases <4 weeks prior to first dose of study therapy Concurrent ocular disorders
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