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.
Treatment: Lurbinectedin — 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.
Check if I qualifyExtracted 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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