Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer
Trial Parameters
Brief Summary
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)
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years, male or female; 2. Patients with histologically and/or cytologically confirmed small cell lung cancer; 3. Disease progression (CTFI ≥ 30 days and ≤ 6 months) occurred after at least 4 cycles of first-line etoposide + platinum two-drug chemotherapy-based treatment, regardless of whether the primary tumor was treated with radiotherapy; the stage of patients with limited stage SCLC should meet more than T1-2, N0, or not suitable for surgery; 4. At least one evaluable lesion (according to RECIST 1.1 criteria); 5. Expected survival time ≥ 3 months; 6. Eastern Cooperative Oncology Group (ECOG) score \< 2; 7. Patients who received no liver metastasis; or the number of liver metastases was ≤ 3 and the longest diameter of a single lesion was ≤ 1.5 cm; or although the longest diameter of a single lesion was \> 1.5 cm, the imaging was stable for at least 3 weeks after local treatment control; 8. Patients with brain metastasis at baseline should meet all the