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OncoMatch/Clinical Trials/NCT05734066

Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma

Is NCT05734066 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Lurbinectedin for refractory ewing sarcoma.

Phase 1/2RecruitingJazz PharmaceuticalsNCT05734066Data as of May 2026

Treatment: LurbinectedinThis 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.

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Extracted eligibility criteria

Cancer type

Sarcoma

Prior therapy

Cannot have received: lurbinectedin (lurbinectedin)

Received prior treatment with lurbinectedin

Cannot have received: trabectedin (trabectedin)

Received prior treatment with trabectedin

Cannot have received: investigational product

Exception: Observational studies are permitted

Received prior treatment with any investigational product within 4 weeks of first infusion of study intervention. Observational studies are permitted.

Cannot have received: live or live attenuated vaccine

Exception: Inactive and mRNA vaccines allowed

Received live or live attenuated vaccines within 4 weeks of the first dose of study treatment or plans to receive live vaccines during study participation. Administration of inactive vaccines or messenger ribonucleic acid (mRNA) vaccines (for example, inactivated influenza vaccines or COVID-19 vaccines) are allowed.

Cannot have received: major surgery

Exception: unless fully recovered

Had major surgery ≤ 4 weeks or radiation therapy ≤ 2 weeks prior to enrollment unless fully recovered. Prior palliative radiotherapy is permitted, provided it was completed at least 2 weeks prior to participant enrollment.

Cannot have received: radiation therapy

Exception: Prior palliative radiotherapy permitted if completed ≥ 2 weeks prior to enrollment

Had major surgery ≤ 4 weeks or radiation therapy ≤ 2 weeks prior to enrollment unless fully recovered. Prior palliative radiotherapy is permitted, provided it was completed at least 2 weeks prior to participant enrollment.

Cannot have received: allogeneic bone marrow transplantation

Received prior allogeneic bone marrow transplantation

Cannot have received: solid organ transplant

Received prior solid organ transplant

Cannot have received: chemotherapy

Received chemotherapy ≤ 3 weeks prior to start of study intervention.

Lab requirements

Blood counts

ANC ≥ 1.0 × 10^9/L (independent of growth factor support within 1 week of screening); platelets ≥ 100 × 10^9/L (without platelet transfusion within previous 7 days); hemoglobin ≥ 8 g/dL (may have been transfused)

Kidney function

Calculated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault for ≥ 18 years; Schwartz equation for < 18 years)

Liver function

AST, ALT ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × institutional ULN (Gilbert's syndrome: bilirubin < 3 × institutional ULN)

Cardiac function

Left ventricular ejection fraction or shortening fraction per institutional norm ≥ institutional lower level of normal

adequate liver function, evidenced by: AST, ALT ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × institutional ULN (Gilbert's syndrome: bilirubin < 3 × institutional ULN). Adequate bone marrow function: ANC ≥ 1.0 × 10^9/L (independent of growth factor support within 1 week of screening); platelets ≥ 100 × 10^9/L (without platelet transfusion within previous 7 days); hemoglobin ≥ 8 g/dL (may have been transfused). Adequate renal function: Calculated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault for ≥ 18 years; Schwartz equation for < 18 years). Adequate cardiac function: Left ventricular ejection fraction or shortening fraction per institutional norm ≥ institutional lower level of normal. Creatine phosphokinase ≤ 2.5 × institutional ULN.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial 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

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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