Response Rate
Name: Azacitidine
Type: DrugArm D
Name: Entinostat
Type: DrugArm D
Name: Nivolumab
Type: DrugArm C Arm D
Description: Being progression-free at 32 weeks after randomization. Response will be assessed from baseline scans at randomization (i.e., within 4 weeks prior to starting epigenetic therapy).
Measure: Response Time: 32 weeksDescription: Progression-free survival (overall) will be measured from the time of randomizationuntil radiologic or clinical progression is noted. Estimation will be by the Kaplan-Meier method.
Measure: Progression free survival Time: 2 yearsDescription: Time to progression (nivolumab) on nivolumab will be measured from the time nivolumab begins until radiologic or clinical progression is noted. Estimation will be by the Kaplan-Meier method.
Measure: Time to Progression Time: 2 yearsDescription: Overall survival will be measured from the time of randomization until death. Estimation will be by the Kaplan-Meier method.
Measure: Overall survival Time: 2 yearsDescription: Toxicities observed in both phases of the study will be assessed by CTCAE 4.0 criteria. We will tabulate toxicities and compare the two treatment groups via methods appropriate for categorical data.
Measure: Safety and tolerability Time: 2 yearsAllocation: Randomized
Parallel Assignment
There is one SNP
All adenocarcinoma patients will be tested for ALK rearrangements and EGFR (Exon 19 Deletion and Exon 21 L8585R Substitution) mutations and must have been treated with prior EGFR or ALK therapy as well as a platinum containing doublet. --- L8585R ---