OncoMatch/Clinical Trials/NCT07328425

Clinical Study in Patients With DSRCT

Is NCT07328425 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Lurbinectedin and Irinotecan for desmoplastic small round cell tumor.

Phase 2RecruitingItalian Sarcoma GroupNCT07328425Data as of May 2026

Treatment: Lurbinectedin · Irinotecan — Patients participating in this study have DSRCT that has spread locally or to other parts of the body and can no longer be surgically removed without causing significant harm. Treatment will continue until the tumor progresses further, severe side effects occur, or either patient or investigator decision. In addition, patients may participate in an optional biological study. The study will analyze the tumor's genes and the molecules related to them. By studying genes and their products, the investigators can better understand the behavior of the tumor and how the body responds to therapies.

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Extracted eligibility criteria

Biomarker criteria

Required: EWSR1 ewsr1-wt1 translocation

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 3 prior lines

Min 1 prior line

Must have received: anthracycline

at least one prior chemotherapy based on anthracycline (considering chemotherapy administered for primary tumour)

Cannot have received: lurbinectedin

Prior treatment with lurbinectedin

Cannot have received: trabectedin

Prior treatment with trabectedin

Cannot have received: Ecubectedin (PM 14)

Prior treatment with Ecubectedin (PM 14)

Cannot have received: PM54

Prior treatment with PM54

Cannot have received: bone marrow and/or stem cell transplantation, and allogenic transplant

Prior bone marrow and/or stem cell transplantation, and allogenic transplant

Lab requirements

Blood counts

platelet count ≥ 100 × 10^9/L, hemoglobin ≥ 9.0 g/dL, white blood cells ≥ 3.0 × 10^9/L and ANC ≥ 2.0 × 10^9/L

Kidney function

calculated creatinine clearance (CrCL) ≥ 30 mL/minute (using Cockcroft-Gault formula)

Liver function

AST and ALT ≤ 3.0 × ULN, even in the presence of liver metastases; total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN

Cardiac function

cardiac ejection fraction ≥50% as measured by echocardiogram

Adequate bone marrow, renal, hepatic, and metabolic function (assessed ≤ 7 days before inclusion in the trial), defined as the following: platelet count ≥ 100 × 10^9/L, hemoglobin ≥ 9.0 g/dL, white blood cells ≥ 3.0 × 10^9/L and absolute neutrophil count (ANC) ≥ 2.0 × 10^9/L, AST and ALT ≤ 3.0 × ULN, even in the presence of liver metastases, total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN, INR < 1.5 (except if patient is on oral anticoagulation therapy), calculated creatinine clearance (CrCL) ≥ 30 mL/minute (using Cockcroft-Gault formula), creatine phosphokinase (CPK) ≤ 2.5 × ULN, albumin ≥ 3.0 g/dL. Cardiac ejection fraction ≥50% as measured by echocardiogram.

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

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