Plinabulin for Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Small Cell Lung Cancer+1 MorePlinabulin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new cancer treatment on patients who haven't responded to other treatments. It's divided into two parts, with the first part testing different doses to see what's safe and effective.

Eligible Conditions
  • Small Cell Lung Cancer
  • Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: 36 Months

12 Months
1-year Overall Survival
36 Months
Assess Adverse Events
Assess immune-related adverse events (irAEs)
Clinical Benefit Rate
Overall Survival
Phase II: Progression-Free Survival (PFS)
Proportion of subjects with a confirmed objective response
6 Months
6-Month Progression-Free Survival
9 Months
Phase I: Maximum Tolerated Dose (MTD)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Phase I (Dose Escalation): nivolumab, ipilimumab and plinabulin
1 of 2
Phase II: nivolumab, ipilimumab, and plinabulin
1 of 2

Experimental Treatment

35 Total Participants · 2 Treatment Groups

Primary Treatment: Plinabulin · No Placebo Group · Phase 1 & 2

Phase I (Dose Escalation): nivolumab, ipilimumab and plinabulinExperimental Group · 3 Interventions: Nivolumab, Ipilimumab, Plinabulin · Intervention Types: Drug, Drug, Drug
Phase II: nivolumab, ipilimumab, and plinabulinExperimental Group · 3 Interventions: Nivolumab, Ipilimumab, Plinabulin · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Ipilimumab
FDA approved
Plinabulin
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months

Who is running the clinical trial?

Salma SabbourLead Sponsor
Bristol-Myers SquibbIndustry Sponsor
2,501 Previous Clinical Trials
3,928,233 Total Patients Enrolled
Rutgers Cancer Institute of New JerseyOTHER
70 Previous Clinical Trials
18,725 Total Patients Enrolled
Jyoti MalhotraLead Sponsor
BeyondSpring Pharmaceuticals Inc.Industry Sponsor
8 Previous Clinical Trials
1,137 Total Patients Enrolled
Jyoti Malhotra, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
Salma Jabbour, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
4 Previous Clinical Trials
111 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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