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Clinical trial

Oral THU-Decitabine + Nivolumab for Advanced Non-Small Cell Lung Cancer

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Last updated:1st Jul 2016

This study looks at the effect of three drugs on lung cancer tumors. This study includes two groups of patients randomized to either Nivolumab, which is the standard of care for this lung cancer, or to Nivolumab with two other drugs, Oral THU and decitabine. Oral THU is an inhibitor or the enzyme cytidine deaminase, an enzyme which deactivates decitabine. Decitabine is a deoxycytidine analogue which depletes DNMT1. By combining these three drugs, this study hopes to inhibit tumor growth more than with Nivolumab alone.

Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combination of Oral THU-Decitabine With Nivolumab for Treatment of Patients With Advanced Non-Small Cell Lung Cancer
Estimated Enrollment: 66
Study Start Date: July 2016
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)

- Experimental:
Nivolumab + Oral THU followed by oral decitabine
- Active Comparator: Nivolumab

Category Value
Study start date 2016-07-01

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