A Study of VS-6766 and VS-6766 + Defactinib in Recurrent KRAS G12V, Other KRAS and BRAF Non-Small Cell Lung Cancer (RAMP202)

  • STATUS
    Recruiting
  • End date
    Dec 24, 2025
  • participants needed
    100
  • sponsor
    Verastem, Inc.
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Updated on 4 October 2022
See if I qualify
measurable disease
BRAF
KRAS
recurrent non-small cell lung cancer
lung carcinoma

Summary

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.

Description

This is a multicenter, open-label Phase 2 study designed to evaluate safety and tolerability and efficacy of VS-6766 versus 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).

Details
Condition Non Small Cell Lung Cancer, KRAS Activating Mutation
Treatment VS-6766, VS-6766 and Defactinib
Clinical Study IdentifierNCT04620330
SponsorVerastem, Inc.
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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