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

Status
Completed
Cancer Type
Lung Cancer
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04620330
Protocol IDs
VS-6766-202 (primary)
NCI-2021-01997
Study Sponsor
Verastem Inc

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.

Objectives

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).

Eligibility

  1. Male or female subjects = 18 years of age
  2. Histologic or cytologic evidence of NSCLC
  3. Known KRAS or BRAF mutation
  4. The subject must have received appropriate prior therapy
  5. Measurable disease according to RECIST 1.1
  6. An Eastern Cooperative Group (ECOG) performance status = 1
  7. Adequate organ function
  8. Adequate recovery from toxicities related to prior treatments
  9. Agreement to use highly effective method of contraceptive
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Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.