Recurrent Non-Small Cell Lung Carcinoma Clinical Trial
Official title:
A Phase I/II Clinical Trial of Nivolumab and Plinabulin for Patients With Advanced Stage Non-small Cell Lung Cancer That Have Progressed Through First Line Platinum Doublet Chemotherapy
This phase I/II trial studies the side effects and best dose of plinabulin when given together with nivolumab and to see how well they work in treating patients with stage IIIB-IV non-small cell lung cancer that has come back or spread to other places in the body. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as plinabulin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab and plinabulin together may work better at treating patients with non-small cell lung cancer.
PRIMARY OBJECTIVES:
I. To determine the safety and tolerability of the combination of nivolumab and plinabulin.
(Phase I)
II. To determine the overall response rate (ORR) of treatment with nivolumab with the
addition of plinabulin in the treatment of advanced stage non-small cell lung cancer in the
second line setting. (Phase II)
SECONDARY OBJECTIVES:
I. To determine the progression free survival (PFS), disease control rate (DCR), duration of
response (DOR) and overall survival (OS) of patients treated with nivolumab in combination
with plinabulin.
II. To determine the safety and tolerability of the combination of plinabulin and nivolumab.
TERTIARY OBJECTIVES:
I. Patients who have a pre-treatment and/or post cycle one biopsy will have flow cytometry of
their tissue to identify infiltration of immune cells, rates of expression of programmed cell
death 1 (PD-1), programmed cell death 2 (PD-2) and programmed cell death 1 ligand 1 (PDL1).
OUTLINE: This is a phase I, dose-escalation study of plinabulin followed by a phase II study.
Patients receive plinabulin intravenously (IV) over 30 minutes and nivolumab IV over 60
minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed up at 28 days.
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