Nivolumab and Plinabulin in Treating Patients With Stage IIIB-IV, Recurrent, or Metastatic Non-small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02846792|
Recruitment Status : Recruiting
First Posted : July 27, 2016
Last Update Posted : November 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|ALK Gene Translocation EGFR Activating Mutation Recurrent Non-Small Cell Lung Carcinoma ROS1 Gene Translocation Stage IIIB Non-Small Cell Lung Cancer AJCC v7 Stage IV Non-Small Cell Lung Cancer AJCC v7||Other: Laboratory Biomarker Analysis Biological: Nivolumab Drug: Plinabulin||Phase 1 Phase 2|
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)
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 29, 2016|
|Estimated Primary Completion Date :||March 31, 2019|
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.
Other: Laboratory Biomarker Analysis
- Maximum tolerated dose of plinabulin and nivolumab (Phase I) [ Time Frame: Up to 28 days ]Defined as no more than 1 of 6 patients experiencing a dose limiting toxicity, graded according to the National Cancer Institute Common Toxicity Criteria version 4.0.
- Overall Response Rate (Phase II) [ Time Frame: Up to 16 months ]Defined as the sum of complete and partial responses for more than 8 weeks according to Response Evaluation Criteria in Solid Tumors version 1.1.
- Disease Control Rate [ Time Frame: Up to 16 months ]Defined as the proportion of patients with complete response, partial response, and stable disease.
- Duration of Response [ Time Frame: Time between receipt of first study drug and until the date of progression, assessed up to 16 months ]Will be summarized using descriptive statistics (mean, standard deviation, median, minimum and maximum values).
- Overall Survival [ Time Frame: From registration until the date of death due to any cause, assessed for up to 16 months ]Will be summarized using descriptive statistics (mean, standard deviation, median, minimum and maximum values).
- Percentage of patients experiencing grade 3 or higher severity of adverse events [ Time Frame: Up to 30 days after last dose ]Adverse events will be graded using the National Cancer Institute Common Toxicity Criteria version 4.0.
- Progression Free Survival [ Time Frame: From registration until objective tumor progression or death due to any cause, whichever comes first, assessed for up to 16 months ]Assessed using Response Evaluation Criteria in Solid Tumors version 1.1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846792
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Rafael Santana-Davila 206-288-6723|
|Principal Investigator: Rafael Santana-Davila|
|Principal Investigator:||Rafael Santana-Davila||Fred Hutch/University of Washington Cancer Consortium|