OncoMatch/Clinical Trials/NCT06128837
Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer
Is NCT06128837 recruiting? Yes, currently enrolling (May 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
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.
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