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

Trial Status: Active

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.

Inclusion Criteria

  • Male or female subjects ≥ 18 years of age
  • Histologic or cytologic evidence of NSCLC
  • Known KRAS 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 or KRAS
  • 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

Colorado

Aurora
University of Colorado Hospital
Status: ACTIVE
Contact: Cole Sprague
Phone: 720-848-8030

Illinois

Chicago
Northwestern University
Status: IN_REVIEW

Texas

Houston
M D Anderson Cancer Center
Status: APPROVED

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).

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Verastem Inc

  • Primary ID VS-6766-202
  • Secondary IDs NCI-2021-01997
  • Clinicaltrials.gov ID NCT04620330