OncoMatch/Clinical Trials/NCT06496048
Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC
Is NCT06496048 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
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.
Frequently asked questions
Is NCT06496048 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior Lurbinectedin, Trabectedin, PM14 (Ecubebectedin) disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages