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

  • Interventional
  • Recruiting
  • NCT04620330
Eligibility Details Visit Clinicaltrials.gov

A Phase 2 Study of 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 VS-6766 monotherapy or VS-6766 in combination with defactinib in subjects with recurrent Non-small cell lung cancer.

This is a multicenter, non-randomized, open-label Phase 1b/2 study designed to evaluate safety and tolerability and efficacy of VS-6766 versus VS-6766 in combination with defactinib in subjects with KRAS-MT 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

At a Glance

National Government IDNCT04620330

IRB#IRB21-0059

Lead SponsorVerastem, Inc.

Lead PhysicianArdaman Shergill

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting