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Checkpoint Inhibitor

Lurbinectedin for Small Cell Lung Cancer

Phase 1
Waitlist Available
Led By Alberto A Chiappori, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
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 up to 12 months
Awards & highlights

Summary

This trial is testing a new combination treatment for small cell lung cancer that has progressed after first-line treatment. The goal is to find the maximum tolerated dose and to see if the combination is safe and effective.

Eligible Conditions
  • Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Maximum Tolerated Dose (MTD) of Lurbinectedin with Nivolumab and Ipilimumab
Phase II: Disease Control Rate
Secondary outcome measures
Overall Response Rate
Overall Survival
Progression Free Survival

Trial Design

3Treatment groups
Experimental Treatment
Group I: Phase 1 Dose Level 3: Nivolumab and Ipilimumab plus LurbinectedinExperimental Treatment3 Interventions
Participants will be treated at dose level 3: nivolumab 1mg/kg, ipilimumab 3mg/kg plus 3.2 mg/m^2 lurbinectedin. Participants will receive nivolumab, ipilimumab and Lurbinectedin every 3 weeks for 4 cycles. After 4 treatment cycles, ipilimumab will be discontinued and participants will continue treatment with a flat dose of 360 mg nivolumab and Lurbinectedin at dose level 3 every 3 weeks.
Group II: Phase 1 Dose Level 2: Nivolumab and Ipilimumab plus LurbinectedinExperimental Treatment3 Interventions
Participants will be treated at dose level 2: nivolumab 1mg/kg, ipilimumab 3mg/kg plus 2.6 mg/m^2 lurbinectedin. Participants will receive nivolumab, ipilimumab and Lurbinectedin every 3 weeks for 4 cycles. After 4 treatment cycles, ipilimumab will be discontinued and participants will continue treatment with a flat dose of 360 mg nivolumab and Lurbinectedin at dose level 2 every 3 weeks.
Group III: Phase 1 Dose Level 1: Nivolumab and Ipilimumab plus LurbinectedinExperimental Treatment3 Interventions
Participants will be treated at dose level 1: nivolumab 1mg/kg, ipilimumab 3mg/kg plus 1.5 mg/m^2 lurbinectedin. Participants will receive nivolumab, ipilimumab and Lurbinectedin every 3 weeks for 4 cycles. After 4 treatment cycles, ipilimumab will be discontinued and participants will continue treatment with a flat dose of 360 mg nivolumab and Lurbinectedin at dose level 1 every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lurbinectedin
2022
Completed Phase 2
~90
Nivolumab
2014
Completed Phase 3
~4740
Ipilimumab
2014
Completed Phase 3
~2610

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsIndustry Sponsor
249 Previous Clinical Trials
34,894 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
549 Previous Clinical Trials
135,701 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,652 Previous Clinical Trials
4,130,740 Total Patients Enrolled
~2 spots leftby Jul 2025
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