Description:
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.
Title
- Brief Title: A Study of VS-6766 v. VS-6766 + Defactinib in Recurrent G12V or Other KRAS-Mutant Non-Small Cell Lung Cancer
- Official Title: 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) Non-Small Cell Lung Cancer (NSCLC)
Clinical Trial IDs
- ORG STUDY ID:
VS-6766-202
- NCT ID:
NCT04620330
Conditions
- Non Small Cell Lung Cancer
- KRAS Activating Mutation
Interventions
Drug | Synonyms | Arms |
---|
VS-6766 | | Part A |
VS-6766 and Defactinib | VS-6766 and VS-6063 | Part A |
Purpose
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.
Detailed Description
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 Arms
Name | Type | Description | Interventions |
---|
Part A | Experimental | To determine the optimal regimen, either VS-6766 monotherapy or VS-6766 in combination with defactinib, for subsequent evaluation for efficacy in the expansion phase (Part B). | - VS-6766
- VS-6766 and Defactinib
|
Part B | Experimental | To determine the efficacy of the optimal regimen identified from Part A | - VS-6766
- VS-6766 and Defactinib
|
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Part A: To determine the optimal regimen, either VS-6766 monotherapy or VS-6766 in combination with defactinib, |
Time Frame: | From start of treatment to confirmation of response; 24 weeks |
Safety Issue: | |
Description: | Confirmed overall response rate per RECIST 1.1 |
Secondary Outcome Measures
Measure: | Overall Response Rate as assessed by Investigator |
Time Frame: | From start of treatment to confirmation of response; 24 weeks |
Safety Issue: | |
Description: | Proportioned subjects achieving a CR or PR as assess by the investigator |
Measure: | Duration of Response (DOR) |
Time Frame: | Time from the first documentation of response to first documentation of progressive disease or death due to any cause, greater than or equal to 6 months |
Safety Issue: | |
Description: | Time of first response to PD as assessed by the IRC |
Measure: | Disease Control Rate (DCR) |
Time Frame: | Greater than or equal to 8 weeks |
Safety Issue: | |
Description: | CR and PR stable disease as assessed by the IRC |
Measure: | Progression Free Survival (PFS) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | From the time of first dose of study intervention to PD or death from any cause |
Measure: | Overall Survival (OS) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | From time of first dose of study intervention to death |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Verastem, Inc. |
Trial Keywords
Last Updated
August 26, 2021