OncoMatch/Clinical Trials/NCT06496048
Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC
Is NCT06496048 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Lurbinectedin and Irinotecan for relapsed small cell lung cancer.
Treatment: Lurbinectedin · Irinotecan · Lurbinectedin · Topotecan — Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of Lurbinectedin monotherapy or Lurbinectedin + Irinotecan combined therapy versus Topotecan comparator in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: etoposide + platinum chemotherapy — first-line
One prior line of etoposide + platinum chemotherapy with/without anti-PD-1 or anti-PD-L1
Cannot have received: Lurbinectedin (Lurbinectedin)
Prior use of Lurbinectedin
Cannot have received: Trabectedin (Trabectedin)
Prior use of Trabectedin
Cannot have received: PM14 (Ecubebectedin) (PM14 (Ecubebectedin))
Prior use of PM14 (Ecubebectedin)
Cannot have received: topoisomerase I inhibitor (Irinotecan, Topotecan)
Prior use of topoisomerase I inhibitors (Irinotecan, Topotecan, etc.)
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL (RBC transfusion allowed >2 weeks prior to enrollment if indicated); absolute neutrophil count ≥ 2.0 × 10^9/L; platelet count ≥ 100 × 10^9/L.
Kidney function
Calculated creatinine clearance (CrCL) ≥ 40 mL/min (using the Cockcroft-Gault formula)
Liver function
Alanine aminotransferase and aspartate aminotransferase ≤ 3.0 × ULN. Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ 1 × ULN. Albumin ≥ 3.0 g/dL.
Adequate organ function as defined below: 1. Hemoglobin ≥ 9.0 g/dL (Red blood cell transfusion is allowed to be given more than 2 weeks prior to enrollment if blood transfusion is clinically indicated); absolute neutrophil count ≥ 2.0 × 10^9/L, and platelet count ≥ 100 × 10^9/L. 2. Alanine aminotransferase and aspartate aminotransferase ≤ 3.0 × ULN. 3. Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ 1 × ULN. 4. Albumin ≥ 3.0 g/dL. 5. Calculated creatinine clearance (CrCL) ≥ 40 mL/min (using the Cockcroft-Gault formula, as detailed in Appendix IV).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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