This study will assess the safety and preliminary efficacy of VS-6766 monotherapy or VS-6766 in combination with defactinib in subjects with recurrent Non-small cell lung cancer.
Name: VS-6766
Name: VS-6766 and Defactinib
Description: Confirmed overall response rate per RECIST 1.1
Measure: Part A: To determine the optimal regimen, either VS-6766 monotherapy or VS-6766 in combination with defactinib, Time: From start of treatment to confirmation of response; 24 weeksDescription: Confirmed overall response rate per RECIST 1.1
Measure: Part B: To determine the efficacy of the optimal regimen identified from Part A Time: From start of treatment to confirmation of response; 24 weeksDescription: Proportioned subjects achieving a CR or PR as assess by the investigator
Measure: Overall Response Rate as assessed by Investigator Time: From start of treatment to confirmation of response; 24 weeksDescription: Time of first response to PD as assessed by the IRC
Measure: Duration of Response (DOR) Time: Time from the first documentation of response to first documentation of progressive disease or death due to any cause, greater than or equal to 8 monthsDescription: CR and PR stable disease as assessed by the IRC
Measure: Disease Control Rate (DCR) Time: Greater than or equal to 8 weeksDescription: From the time of first dose of study intervention to PD or death from any cause
Measure: Progression Free Survival (PFS) Time: Up to 5 yearsDescription: From time of first dose of study intervention to death
Measure: Overall Survival (OS) Time: Up to 5 yearsAllocation: Randomized
Single Group Assignment
There is one SNP
A Study of VS-6766 v. VS-6766 + Defactinib in Recurrent G12V or Other KRAS-Mutant Non-Small Cell Lung Cancer This study will assess the safety and preliminary efficacy of VS-6766 monotherapy or VS-6766 in combination with defactinib in subjects with recurrent Non-small cell lung cancer. --- G12V ---