A Randomized Phase II Study of Epigenetic Priming with Azacitidine and Entinostat Prior to Nivolumab versus Nivolumab Alone in Subjects with Recurrent Metastatic Non-Small Cell Lung Cancer.
Primary objective is the response rate to Nivolumab following epigenetic priming. Secondary endpoint is progression free survival, time to progression, overall survival, safety and tolerability as well as laboratory correlation of response.
Patients will have stage IIIB, IV or recurrent NSCLC, with measureable disease, following at least 1 platinum based chemotherapy and not more than 3 prior therapies for stage IIIB/IV disease. Patient that are EGFR or ALK mutation +, must have prior therapy for mutation, as well as platinum containing doublet. Patients must have available archival or fresh tissue. Patient cannot have history of known autoimmune disease. Patients with interstitial lung disease and those requiring continuous supplemental oxygen are excluded. Patient with conditions that require systemic treatment with corticosteroids are excluded.
Eligible patients will be randomized to 1 of 2 arms of epigenetic therapy for 2 cycles: A) 5 Azacitidine SQ Days 1-6 & 8-10 with Entinostat orally on Days 3 & 10 or B). CC-486 orally Day 1-21. Following epigenetic therapy, both arms will receive Nivolumab (anti-PD 1) every 2 weeks until disease progression.
09/19/2014 04:03 AM