Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma (NCT05734066)
A Phase 1/2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Recommended Phase 2 Dose (RP2D), and Efficacy of Lurbinectedin Monotherapy in Pediatric Participants With Previously Treated Solid Tumors Followed by Expansion to Assess Efficacy and Safety in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma.
🩺 Plain-English Summary (8th-Grade Level)
This study is conducted in two phases. The phase 1 portion of the study evaluates the safety, tolerability, pharmacokinetics (PK), recommended phase 2 dose (RP2D), and effectiveness of lurbinectedin monotherapy in pediatric participants with previously treated solid tumors. This is followed by the phase 2 portion, to further assess the effectiveness and safety in pediatric and young adult participants with recurrent/refractory Ewing sarcoma.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital of Los Angeles — Los Angeles, California
Age range: 2 Years to 30 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- Children's Hospital of Los Angeles — Los Angeles, California
- Lucile Packard Children's Hospital — Palo Alto, California
- Children's National Hospital — Washington D.C., District of Columbia
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida
- Children's Healthcare of Atlanta at Arthur M. Blank Hospital — Atlanta, Georgia
- Johns Hopkins University — Baltimore, Maryland
- Corewell Health — Grand Rapids, Michigan
- Memorial Sloan Kettering Cancer Center — New York, New York
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
- Nationwide Children's Hospital — Columbus, Ohio
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- St. Jude Children's Research Hospital — Memphis, Tennessee
- Children's Health Dallas — Dallas, Texas
- The University of Texas MD Anderson Cancer Center — Houston, Texas
- The Hospital for Sick Children — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (215) 832-3750
Email: ClinicalTrialDisclosure@JazzPharma.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Refractory Ewing Sarcoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.