There is one clinical trial.
S1400K of Lung-MAP seeks to evaluate the overall response rate with ABBV-399 (Process II) in patients with c-MET positive SCCA. S1400K is a biomarker-driven study for patients with Stage IV or recurrent squamous cell lung cancer, who have c-MET positive squamous cell tumors.
Lung-MAP S1400K: c-MET Positive S1400K of Lung-MAP seeks to evaluate the overall response rate with ABBV-399 (Process II) in patients with c-MET positive SCCA. --- S1400K ---
Lung-MAP S1400K: c-MET Positive S1400K of Lung-MAP seeks to evaluate the overall response rate with ABBV-399 (Process II) in patients with c-MET positive SCCA. --- S1400K --- --- S1400K ---
S1400K is a biomarker-driven study for patients with Stage IV or recurrent squamous cell lung cancer, who have c-MET positive squamous cell tumors. --- S1400K ---
Description: Primary analyses will be performed using a more restricted definition of c-Met -positivity criteria. The observation of at least 10 responses will be considered evidence to rule out the null hypothesis of a 15% response rate.
Measure: Response Rate Time: 11 monthsDescription: Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median times.
Measure: Investigator-assessed progression-free survival (IA-PFS) Time: Up to 3 yearsDescription: Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median times.
Measure: Overall survival (OS) Time: Up to 3 yearsDescription: A design with 91% power and 1-sided 0.05 level type I error would require 40 eligible patients to rule out an objective response rate (ORR) of 15% or less if the true ORR is 35% or greater.
Measure: Overall response rate (ORR) Time: Up to 3 yearsDescription: Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median times.
Measure: Duration of response (DoR) Time: Up to 3 yearsDescription: With 40 patients, toxicity rates can be estimated within 16% with 95% confidence. Any toxicity with at least 5% prevalence has at least an 87% chance of being observed.
Measure: Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 Time: up to 3 years