Pembro and Vorinostat for Patients With Stage IV Non-small Cell Lung Cancer (NSCLC)

Brief Summary:
The main purpose of this study is to see whether the combination of two drugs called pembrolizumab and vorinostat can help people with advanced lung cancer. Researchers also want to find out if the combination of pembrolizumab and vorinostat is safe and tolerable. This study will compare the effects of the combination of two drugs called pembrolizumab and vorinostat with the effects of pembrolizumab alone. The U.S. Food and Drug Administration (FDA) has approved pembrolizumab for use to treat a deadly skin cancer called melanoma and lung cancer and vorinostat to treat some forms of blood and lymph node cancers.

Detailed Description:
A Phase I/Randomized Phase II clinical trial of pembrolizumab and vorinostat in Eastern Cooperative Oncology Group (ECOG) 0-1 patients with immune therapy naïve and immune therapy pretreated locally advanced or metastatic NSCLC who have progressed through one prior line of therapy.

The begins with a phase I dose escalation utilizing the modified continuous reassessment method (O'Quigley, Pepe, & Fisher, 1990). This would be followed by a phase I expansion at the maximum tolerated dose (MTD) in 18 NSCLC patients who have been previously treated with anti-PD-1 or anti-PD-L1 therapy. In parallel, a separate phase II arm will randomize 70 patients to a pembrolizumab alone group and a pembrolizumab plus vorinostat group.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Pembrolizumab and Vorinostat in Patients With Immune Therapy Naïve and Immune Therapy Pretreated Stage IV NSCLC
Actual Study Start Date: February 24, 2016
Estimated Primary Completion Date: November 2019
Estimated Study Completion Date: November 2020

Arms:
- Experimental: Phase I Dose Escalation
- Experimental: Phase Ib Expansion
- Active Comparator: Arm A: Pembrolizumab
- Active Comparator: Arm B: Pembrolizumab plus Vorinostat