OncoMatch/Clinical Trials/NCT06128837
Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer
Official title: A Multicenter, Randomized, Open-label, Parallel-design Phase 3 Study to Evaluate the Efficacy and Safety of LY01610 (Irinotecan Hydrochloride Liposome Injection) Versus Topotecan in Patients With Recurrent Small Cell Lung Cancer (SCLC)
Is NCT06128837 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies multiple treatments including Irinotecan hydrochloride liposome and Topotecan for relapsed small cell lung cancer.
Treatment: Irinotecan hydrochloride liposome · Topotecan — This is a multicenter，randomized, open label, active-controlled, parallel-group study comparing efficacy and safety of LY01610(Irinotecan hydrochloride liposome Injection) and Topotecan in Patients with Recurrent Small Cell Lung Cancer (SCLC)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Small Cell Lung Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: etoposide + platinum two-drug chemotherapy-based treatment (etoposide, platinum) — first-line
Disease progression (CTFI ≥ 30 days and ≤ 6 months) occurred after at least 4 cycles of first-line etoposide + platinum two-drug chemotherapy-based treatment
Cannot have received: topoisomerase I inhibitor (irinotecan, irinotecan modified, topotecan)
Previous treatment with irinotecan or irinotecan modified, topotecan or other topoisomerase I inhibitors
Cannot have received: systemic anti-tumor therapy
Patients who have received systemic anti-tumor therapy in 4 weeks before randomization
Cannot have received: clinical trial drugs/devices
Patients who have applied other clinical trial drugs/devices before randomization
Lab requirements
Blood counts
neutrophil (ANC) ≥ 1.5 × 10^9/L, platelet (PLT) ≥ 100 × 10^9/L, hemoglobin (Hb) ≥ 90 g/L
Kidney function
serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 40 mL/min
Liver function
total bilirubin (TBIL) ≤ 1.0 × ULN; AST and ALT ≤ 2.0 × ULN; if liver metastases, AST and ALT ≤ 3 × ULN; serum albumin ≥ 30 g/L
Organ function meeting the following criteria at screening: a.Blood routine: neutrophil (ANC) ≥ 1.5 × 10^9/L, platelet (PLT) ≥ 100 × 10^9/L, hemoglobin (Hb) ≥ 90 g/L; b.Liver function: total bilirubin (TBIL) ≤ 1.0 × ULN; AST and ALT ≤ 2.0 × ULN; if liver metastases, AST and ALT ≤ 3 × ULN; serum albumin ≥ 30 g/L; c.Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 40 mL/min; d.Coagulation function: PT-INR < 1.5;
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06128837 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior topoisomerase I inhibitor, systemic anti-tumor therapy, clinical trial drugs/devices 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