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

Part of paid clinical trials in La Jolla, California.

Sponsor
Lyudmila Bazhenova, M.D.
Study ID
NCT02812667
Phase
PHASE1
Status
Completed

Conditions

  • Non-small Cell Lung Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 29, 2016
Status verified
Nov 2025
Primary completion
Nov 24, 2024
Completion
Oct 24, 2025

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab + Plinabulin
    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

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-

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By research site
UC San Diego Moores Cancer Center· La Jolla, CA

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