SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01928576

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Randomized Phase II Study of Epigenetic Therapy With Azacitidine and Entinostat With Concurrent Nivolumab Versus Nivolumab Alone in Subjects With Recurrent Metastatic Non-Small Cell Lung Cancer.

Response Rate

NCT01928576 Non-Small Lung Cancer, Epigenetic Therapy
MeSH: Lung Neoplasms
HPO: Neoplasm of the lung

3 Interventions

Name: Azacitidine

Type: Drug

Arm D

Name: Entinostat

Type: Drug

Arm D

Name: Nivolumab

Type: Drug

Arm C Arm D


Primary Outcomes

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 weeks

Secondary Outcomes

Description: 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 years

Description: 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 years

Description: 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 years

Description: 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 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L8585R

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 ---



HPO Nodes


HPO:
Neoplasm of the lung
Genes 43
WT1 KRAS SLC22A18 STK11 IRF1 AKT1 C11ORF95 PRKN PPP2R1B ERBB2 TRPV3 TSC1 POU6F2 TSC2 EWSR1 RELA KEAP1 REST DIS3L2 SFTPA2 GPC3 MBTPS2 LMNA PTEN BRAF BRCA2 EGFR RB1 TRIP13 PDGFRB TERT SFTPC PIK3CA TRIM28 DICER1 MAP3K8 HPGD SLCO2A1 H19 TP53 NOTCH3 BAP1 WRN