Nivolumab in Combination With Plinabulin in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT02812667 | Completed Phase 1 DMC

• 1 other identifier: 160186
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine whether plinabulin (also known as BPI-2358) has an effect on cancer and body in combination with nivolumab, a standard treatment for metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy. Plinabulin inhibits tumor growth by targeting both new and existing blood vessels going to the tumor as well as killing tumor cells. Plinabulin is an investigational drug, a drug that is not approved for use outside of research studies by regulatory agencies. Up to 38 patients will be enrolled.

Conditions

Non-small Cell Lung Cancer Metastatic

Keywords

Metastatic; NSCLC; nivolumab; plinabulin; BPI-2358; opdivo; Non-Small Cell Lung Cancer; cancer

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD)

  2 years

• Frequency and severity of treatment-related adverse events as assessed by CTCAE v4.

  2 years

Secondary Outcomes (4)

• Objective response rate (ORR)

  2 years

• Disease control rate (DCR)

  2 years

• Progression free survival (PFS)

  2 years

• Overall survival (OS)

  2 years

Study Arms (1)

Nivolumab + Plinabulin

EXPERIMENTAL

Nivolumab 240mg IV, day 1 and 15 until disease progression Plinabulin 3.5mg/m2, 20mg/m2, 30 mg/m2 or 40mg/m2 IV, day 1,8 and 15 until disease progression

Drug: Nivolumab + Plinabulin

Interventions

Nivolumab + Plinabulin DRUG

Nivolumab + Plinabulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with histologically or cytologically-confirmed metastatic NSCLC whose disease progressed during/after treatment with at least one platinum-containing chemotherapy regimen.
• At least 1 prior systemic therapy for metastatic disease. Adjuvant chemotherapy or concurrent chemoradiation for early stage disease does not count as prior therapy unless patients progressed within 6 months of completion of chemotherapy
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
• Life expectancy ≥ 12 weeks
• Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST).
• Adequate hematopoietic, electrolyte, hepatic, and renal laboratory findings.
• Prior chemotherapy must have been completed at least 4 weeks or at least 5 half-lives (whichever is longer) before study drug administration, and all adverse events have either returned to baseline or stabilized
• Prior treated brain metastases are allowed. However, prior treated brain metastases must be without MRI evidence of progression for at least 4 weeks and off systemic steroids for at least 2 weeks before study drug administration
• Prior definitive radiation therapy must have been completed at least 4 weeks before study drug administration. Prior palliative radiotherapy should be completed at least 2 weeks before study drug administration. Whole brain radiation therapy (WBRT), stereotactic radiosurgery (SRS) and focal radiation to the sites of pain or bronchial obstruction will be considered palliative. No radiopharmaceuticals (strontium, samarium) within 8 weeks before study drug administration
• Prior major surgery must be completed at least 4 weeks before study drug administration. Prior minor surgery must be completed at least 1 week before study drug administration and subjects should be recovered. Percutaneous biopsies should be completed at least 10 days prior to study drug administration;
• A negative serum pregnancy test at screening for women of childbearing potential.

You may not qualify if:

• History of grade 3 or above hypersensitivity reactions to other monoclonal antibodies
• Subjects with a history of a cardiovascular illness.
• Uncontrolled hypertension, SBP\> 160 or DBP\>100
• Symptomatic or untreated brain metastases
• Presence of leptomeningeal disease
• Pulmonary conditions, which in the PI's opinion would increase the risk of immunotherapy-related pulmonary toxicity.
• Has active, non-infectious pneumonitis
• Presence of a second malignancy, excluding non-melanomatous skin cancer unless in remission for 3 years
• Subjects with any active, known, or suspected autoimmune disease.
• History of ileus or other significant gastrointestinal disorder known to predispose to ileus or chronic bowel hypomotility.
• Prior therapy with microtubule destabilizing agents for NSCLC (ie. Vinorelbine)
• Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody (or any other antibody targeting T cell co-stimulation pathways);
• Known history of Human Immunodeficiency Virus;
• Active infection requiring therapy, positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA)
• Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events

Sponsors & Collaborators

• Lyudmila Bazhenova, M.D.: lead
• BeyondSpring Pharmaceuticals Inc.: collaborator

Study Sites (1)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

Nivolumab; NPI 2358

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Lyudmilla Bazhenova, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 24, 2016
• Study Start: August 29, 2016
• Primary Completion: November 24, 2024
• Study Completion: October 24, 2025
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (1)