NCT02638090

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

A Phase I/II Study of Pembrolizumab and Vorinostat in Patients With Immune Therapy Naïve and Immune Therapy Pretreated Stage IV NSCLC

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Vorinostat	Administered per treatment arm guidelines.
DRUG	Pembrolizumab	Administered per treatment arm guidelines.

Timeline

• Start date: 2016-03-22
• Primary completion: 2024-01-21
• Completion: 2026-07-01
• First posted: 2015-12-22
• Last updated: 2025-12-22
• Results posted: 2025-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study