Actively Recruiting
Lurbinectedin in FET-Fused Tumors
Led by Children's Hospital of Philadelphia · Updated on 2026-03-31
63
Participants Needed
6
Research Sites
261 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
J
Jazz Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to find out if a drug called lurbinectedin (the "study drug") is safe and effective at treating people with recurrent or relapsed solid tumors, including Ewing sarcoma.
CONDITIONS
Official Title
Lurbinectedin in FET-Fused Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 10 years or older
- For Phase 1: Confirmed recurrent or relapsed solid tumor with known FET fusion (EWSR1, FUS, or TAF15) documented by genetic testing
- For Phase 1: Patients with Ewing sarcoma with EWS-FLI1 eligible for dose escalation; patients with alternative FET-ETS fusions eligible for exploratory cohort
- For Phase 2: Confirmed recurrent or relapsed Ewing sarcoma with EWS-FLI1 fusion confirmed by genetic testing and available tissue for central confirmation
- ECOG Performance Status of 0 or 1 for patients older than 16 years, or Lansky score of at least 70 for patients younger than 16 years
- At least one measurable or evaluable disease site on CT or MRI within 28 days before treatment
- Adequate liver, kidney, bone marrow, muscle, and cardiac function as defined by specific laboratory and clinical criteria
- Written, voluntary informed consent
- Fertile participants must agree to use effective birth control during and after the study
- Patients 18 years or older must be willing to undergo tumor biopsy at study entry; Ewing sarcoma or DSRCT patients must be willing to undergo biopsy post-treatment or have archival tissue available
- Sufficient time elapsed since previous therapies (ranging from 2 weeks to 6 months, depending on therapy type)
- Recovery to baseline or Grade 1 or less from prior treatment side effects except alopecia and decreased reflexes
You will not qualify if you...
- Prior treatment with trabectedin or lurbinectedin
- Known brain metastases
- Known bleeding disorders
- Pregnancy or breastfeeding
- Currently receiving another investigational drug or anticancer agent
- Use of over-the-counter or herbal supplements with potential liver toxicity
- Use of strong or moderate CYP3A4 inhibitors or inducers within 14 days before study drug
- Serious unrelated illness or uncontrolled infection that may interfere with study participation
- Inability or likely inability to comply with study safety monitoring
- Active viral hepatitis (A, B, or C)
- For Desmoplastic Small Round Cell Tumor (DSRCT) patients, enrollment restricted until at least 3 non-DSRCT patients have enrolled without dose limiting toxicity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
5
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
6
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
T
Theodore Laetsch, MD
CONTACT
M
Meghan Donnelly
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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