Nivolumab + Plinabulin for 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

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 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

Who is the study for?

This trial is for adults with metastatic non-small cell lung cancer (NSCLC) that worsened after platinum-based chemo. They must have had at least one other systemic treatment, be in fairly good health (ECOG ≤1), and expected to live at least 12 weeks. Participants need a measurable tumor and adequate organ function, should be past certain treatments like brain radiation or surgery by specific times, and can't have untreated brain metastases.

What is being tested?

The study tests plinabulin combined with nivolumab against NSCLC. Plinabulin is experimental and aims to block tumor blood supply and kill cancer cells. Nivolumalb is standard for this cancer post-chemo failure. Up to 38 patients will join the study to see if this combo improves their condition.

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, nausea, changes in blood counts which could increase infection risk or cause bleeding issues. Specific side effect profiles of plinabulin are not detailed but may align with those known from similar drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I finished chemotherapy over 4 weeks ago or 5 half-lives ago, and any side effects are stable or gone.

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I finished my radiation therapy at least 4 weeks ago, or palliative radiation 2 weeks ago, and haven't had radiopharmaceuticals in the last 8 weeks.

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My NSCLC worsened after treatment with a platinum-based chemotherapy.

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I had major surgery over 4 weeks ago, minor surgery over a week ago, or a biopsy over 10 days ago.

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I am fully active or can carry out light work.

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My brain metastases have been treated, stable for 4 weeks, and I've been off steroids for 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

0 / 6Eligibility criteria met