Nivolumab and Plinabulin in Treating Patients With Stage IIIB-IV, Recurrent, or Metastatic Non-sm… (NCT02846792) | Clinical Trial Compass
TerminatedPhase 1/2
Nivolumab and Plinabulin in Treating Patients With Stage IIIB-IV, Recurrent, or Metastatic Non-small Cell Lung Cancer
Stopped: Immunotherapy approved for NSCLC in the first line setting
United States5 participantsStarted 2017-06-14
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subjects must have histologically or cytologically-documented stage IIIB or stage IV, recurrent, or metastatic non-small cell lung cancer (NSCLC)
* Subjects must have received prior platinum doublet based treatment
* Up to 2 lines of prior systemic therapy for metastatic disease are permitted
* Adjuvant chemotherapy or concurrent chemoradiation for early stage disease does not count as prior therapy unless subject progressed within 6 months of completion of regimen
* Patients with known activating mutations in epidermal growth factor receptor (EGFR), or known translocation in anaplastic lymphoma kinase (ALK) or ROS-1 are eligible provided they have progressed on or were intolerant to Food and Drug Administration (FDA) approved targeted therapy
* Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Subjects, including those in the dose-escalation portion of the study, must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; imagining must be within 28 days of trial enrollment
* Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site prior to trial enrollment
* Absolute neutrophil count (ANC) \>= 1000/mm\^3
* Platelets \>= 75,000/dL
* Hemoglobin \>= 9 g/dL
* Total bilirubin =\< 1.5 mg/dL x upper limit of normal (ULN) (except subjects with Gilbert syndrome who can have total bilirubin …
What they're measuring
1
Maximum Tolerated Dose of Plinabulin and Nivolumab (Phase I)
Timeframe: Up to 28 days
2
Overall Response Rate (Phase II)
Timeframe: Time between receipt of first study drug until disease progression date, unacceptable toxicity or withdrawal of patient consent, assessed up to 16 months