OncoMatch/Clinical Trials/NCT05918640
Lurbinectedin in FET-Fused Tumors
Is NCT05918640 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies Lurbinectedin for ewing sarcoma.
Treatment: Lurbinectedin — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Sarcoma
Biomarker criteria
Required: EWSR1 fusion
known FET fusion (fusion that contains EWSR1, FUS, or TAF15)
Required: FUS fusion
known FET fusion (fusion that contains EWSR1, FUS, or TAF15)
Required: TAF15 fusion
known FET fusion (fusion that contains EWSR1, FUS, or TAF15)
Required: EWSR1 rearrangement
EWSR1 rearrangement confirmed by FISH
Required: EWSR1 EWS-FLI1 fusion
confirmation of EWS-FLI1 fusion and breakpoint by Next generation sequencing or PCR
Demographics
Prior therapy
Must have received: primary therapy
recurrent or relapsed solid tumor failing primary therapy
Cannot have received: trabectedin (trabectedin)
Prior therapy with trabectedin
Cannot have received: lurbinectedin (lurbinectedin)
Prior therapy with lurbinectedin
Lab requirements
Blood counts
ANC ≥ 1,000/µL; Platelets ≥ 100,000/µL; see protocol for transfusion and medication timing
Kidney function
Creatinine clearance (Schwartz for <18y, Cockroft-Gault for ≥18y) or GFR ≥ 50 mL/min/m2 or serum creatinine ≤ age/gender values
Liver function
ALT ≤ 2.5X ULN (ULN=45 U/L); AST ≤ 2.5X ULN (ULN=50 U/L); Total bilirubin ≤ 1.5X institutional ULN (Gilbert's syndrome <3X ULN)
Cardiac function
CPK CTCAE 5 Grade ≤ 1; LVEF ≥50% OR SF ≥28%
Meets organ function requirements as outlined below: Liver: ALT ≤ 2.5X ULN... Renal: Creatinine clearance... Bone marrow: ANC ≥ 1,000/µL... Cardiac: LVEF ≥50% OR SF ≥28%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Cedars-Sinai Medical Center · Los Angeles, California
- University of Iowa Hospitals and Clinics · Iowa City, Iowa
- Dana-Farber Cancer Institute · Boston, Massachusetts
- University of Michigan · Ann Arbor, Michigan
- Memorial Sloan Kettering Cancer Center · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05918640 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior trabectedin, lurbinectedin disqualifies patients from enrollment.
Does this trial require EWSR1?
Yes, EWSR1 fusion is a required biomarker for enrollment.
Does this trial require FUS?
Yes, FUS fusion is a required biomarker for enrollment.
Does this trial require TAF15?
Yes, TAF15 fusion is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages