A Study of Avutometinib (VS-6766) + Defactinib in Recurrent KRAS G12V, Other KRAS and BRAF Non-Small Cell Lung Cancer
- Interventional
- Recruiting
- NCT04620330
Contact Information
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)
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.
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).
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
Inclusion Criteria:
- Male or female subjects ≥ 18 years of age
- Histologic or cytologic evidence of NSCLC
- Known KRAS or BRAF mutation
- The subject must have received appropriate prior therapy
- Measurable disease according to RECIST 1.1
- An Eastern Cooperative Group (ECOG) performance status ≤ 1
- Adequate organ function
- Adequate recovery from toxicities related to prior treatments
- Agreement to use highly effective method of contraceptive
Exclusion Criteria:
- Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy
- History of prior malignancy, with the exception of curatively treated malignancies
- Major surgery within 4 weeks (excluding placement of vascular access)
- History of treatment with a direct and specific inhibitor of MEK, KRAS or BRAF except for treatment of BRAF V-600E mutant NSCLC
- Exposure to strong CYP2C9 and CYP3A4 inhibitors or inducers within 7 days prior to the first dose and during the course of therapy
- Symptomatic brain metastases requiring steroids or other local interventions.
- Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy
- Active skin disorder that has required systemic therapy within the past 1 year
- History of rhabdomyolysis
- Concurrent ocular disorders
- Concurrent heart disease or severe obstructive pulmonary disease
- Subjects with the inability to swallow oral medications
- Male or female subjects ≥ 18 years of age
- Histologic or cytologic evidence of NSCLC
- Known KRAS or BRAF mutation
- The subject must have received appropriate prior therapy
- Measurable disease according to RECIST 1.1
- An Eastern Cooperative Group (ECOG) performance status ≤ 1
- Adequate organ function
- Adequate recovery from toxicities related to prior treatments
- Agreement to use highly effective method of contraceptive
Exclusion Criteria:
- Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy
- History of prior malignancy, with the exception of curatively treated malignancies
- Major surgery within 4 weeks (excluding placement of vascular access)
- History of treatment with a direct and specific inhibitor of MEK, KRAS or BRAF except for treatment of BRAF V-600E mutant NSCLC
- Exposure to strong CYP2C9 and CYP3A4 inhibitors or inducers within 7 days prior to the first dose and during the course of therapy
- Symptomatic brain metastases requiring steroids or other local interventions.
- Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy
- Active skin disorder that has required systemic therapy within the past 1 year
- History of rhabdomyolysis
- Concurrent ocular disorders
- Concurrent heart disease or severe obstructive pulmonary disease
- Subjects with the inability to swallow oral medications