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OncoMatch/Clinical Trials/NCT05918640

Lurbinectedin in FET-Fused Tumors

Is NCT05918640 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Lurbinectedin for ewing sarcoma.

Phase 1/2RecruitingChildren's Hospital of PhiladelphiaNCT05918640Data as of May 2026

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.

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Extracted eligibility criteria

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

Prior therapy

Min 1 prior line

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 →

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Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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