| Histology |
NSCLC, all subtypes
|
| Tumor stage |
Stage I - IIIStage III - IV |
| Host / recruiting site 1 |
Erasmus MC
|
Enrollment |
Closed
|
| Host / recruiting site 2 |
LUMC
|
Enrollment |
Closed
|
| 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
|
| Contact information |
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|
