Nivolumab and Plinabulin in Treating Patients With Stage IIIB-IV, Recurrent, or Metastatic Non-small Cell Lung Cancer

Conditions

• ALK Gene Translocation
• EGFR Activating Mutation
• ROS1 Gene Translocation
• Recurrent Non-Small Cell Lung Carcinoma
• Stage IIIB Non-Small Cell Lung Cancer AJCC v7
• Stage IV Non-Small Cell Lung Cancer AJCC v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — BIOLOGICAL
  Given IV
• Plinabulin — DRUG
  Given IV

Study Details

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.

Key Dates

Start date

Jun 14, 2017

Status verified

Feb 2019

Primary completion

Jul 12, 2018

Completion

Aug 16, 2018

Study Design

Enrollment

5 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (plinabulin, nivolumab)
  Patients receive plinabulin 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.

Primary Outcome Measure

Maximum Tolerated Dose of Plinabulin and Nivolumab (Phase I) [ Time Frame: Up to 28 days ]

Locations (1)

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