NCT04620330

A Study of Avutometinib (VS-6766) + Defactinib in Recurrent KRAS G12V, Other KRAS and BRAF Non-Small Cell Lung Cancer

A Phase 2 Study of Avutometinib (VS-6766) (Dual RAF/MEK Inhibitor) as a Single Agent and In Combination With Defactinib (FAK Inhibitor) in Recurrent KRAS-Mutant (KRAS-MT) and BRAF-Mutant (BRAF-MT) Non-Small Cell Lung Cancer (NSCLC) (RAMP 202)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Verastem, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and efficacy of avutometinib (VS-6766) monotherapy or VS-6766 in combination with defactinib in subjects with recurrent Non-small cell lung cancer.

Detailed description

This is a multicenter, open-label Phase 2 study designed to evaluate safety and tolerability and efficacy of avutometinib (VS-6766) versus avutometinib (VS-6766) in combination with defactinib in subjects with KRAS and BRAF mutant NSCLC following treatment with an appropriate platinum-based regimen and an approved immune checkpoint inhibitor (CPI).

Conditions

• Non Small Cell Lung Cancer
• KRAS Activating Mutation

Interventions

Type	Name	Description
DRUG	avutometinib (VS-6766)	Monotherapy
DRUG	avutometinib (VS-6766) and Defactinib	Combination therapy

Timeline

• Start date: 2020-12-31
• Primary completion: 2023-08-29
• Completion: 2023-12-12
• First posted: 2020-11-06
• Last updated: 2024-01-12

Locations

45 sites across 5 countries: United States, France, Germany, Italy, Spain

Regulatory

• FDA-regulated drug study