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Report for Clinical Trial NCT01928576

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Study of Epigenetic Therapy With Azacitidine and Entinostat With Concurrent Nivolumab in Subjects With 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
Group Labels: 3

Arm D Arm E Arm F

Name: Entinostat

Type: Drug
Group Labels: 3

Arm D Arm E Arm F

Name: Nivolumab

Type: Drug
Group Labels: 4

Arm C Arm D Arm E Arm F


Primary Outcomes

Description: Percentage of participants with response to combination Nivolumab and epigenetic therapy. Response will be assessed by RECIST 1.1 criteria, where complete response (CR)= disappearance of all target lesions, partial response (PR) is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.

Measure: Objective Response

Time: 2 years

Secondary Outcomes

Description: Number of months from the time of randomization until radiologic (per RECIST 1.1) or clinical progression or death, whichever comes first.

Measure: Progression free survival

Time: 2 years

Description: Number of months from the time nivolumab begins until radiologic (per RECIST 1.1) or clinical progression is noted.

Measure: Time to Progression

Time: 2 years

Description: Number of months from the time of randomization until death. Estimation will be by the Kaplan-Meier method.

Measure: Overall survival

Time: 2 years

Description: Number of participants who experience adverse events as defined by CTCAE v4.0.

Measure: Safety and tolerability as assessed by number of participants with adverse events

Time: 2 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L8585R

- All adenocarcinoma patients must be tested for ALK rearrangements and EGFR (Exon 19 Deletion and Exon 21 L8585R Substitution) mutations and must have been treated with EGFR or ALK TKI therapy if found to have an actionable alteration. --- L8585R ---



HPO Nodes


HPO: