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Monoclonal Antibodies
Nivolumab + Plinabulin for Non-Small Cell Lung Cancer
Phase 1
Waitlist Available
Led By Lyudmilla Bazhenova, MD
Research Sponsored by Lyudmila Bazhenova, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether the investigational drug plinabulin, in combination with the standard treatment nivolumab, can help to shrink tumors in people with metastatic squamous non-small cell lung cancer that has progressed after treatment with platinum-based chemotherapy.
Eligible Conditions
- Non-Small Cell Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency and severity of treatment-related adverse events as assessed by CTCAE v4.
Maximum tolerated dose (MTD)
Secondary outcome measures
Disease control rate (DCR)
Objective response rate (ORR)
Overall survival (OS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Nivolumab + PlinabulinExperimental Treatment1 Intervention
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
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Who is running the clinical trial?
Lyudmila Bazhenova, M.D.Lead Sponsor
1 Previous Clinical Trials
7 Total Patients Enrolled
BeyondSpring Pharmaceuticals Inc.Industry Sponsor
8 Previous Clinical Trials
1,158 Total Patients Enrolled
Lyudmilla Bazhenova, MDPrincipal InvestigatorUniversity of California, San Diego
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