Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer

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 cyclesof first-line etoposide + platinum two-drug chemotherapy-based treatment, regardlessof whether the primary tumor was treated with radiotherapy; the stage of patients withlimited 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 ≤ 3and the longest diameter of a single lesion was ≤ 1.5 cm; or although the longestdiameter of a single lesion was > 1.5 cm, the imaging was stable for at least 3 weeksafter local treatment control;
8. Patients with brain metastasis at baseline should meet all the following conditions:lesions not involving the brainstem, the number of brain metastases ≤ 2 (but patientswith only intracranial target lesions should be excluded), imaging stability for atleast 3 weeks after local treatment control, and no application of dehydration drugsand hormones before screening,Without any symptoms of brain metastasis;
9. Organ function meeting the following criteria at screening: a.Blood routine:neutrophil (ANC) ≥ 1.5 × 109/L, platelet (PLT) ≥ 100 × 109/L, hemoglobin (Hb) ≥ 90g/L; b.Liver function: total bilirubin (TBIL) ≤ 1.0 × upper limit of normal (ULN);aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.0 × ULN; ifliver 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.Coagulationfunction: Prothrombin time - international normalized ratio (PT-INR) < 1.5;
10. Has fully understood and voluntarily signed a written informed consent form for thisstudy and is able to comply with the requirements and restrictions listed in theinformed consent form;
11. Female subjects of childbearing potential and male subjects with partners ofchildbearing potential agree to use reliable contraceptive measures during the studyand within 6 months after the infusion of study drug.

Exclusion Criteria:

1. Pathological diagnosis of compound small cell lung cancer;
2. Patients with meningeal metastasis, spinal cord tumor invasion, spinal cordcompression syndrome;
3. Superior vena cava syndrome with symptoms or significantly aggravated imaging, whichmay require radiotherapy/surgery/endoscopic therapy/intervention and other non-medicaltreatment; the presence of large amount of pleural effusion, ascites and/orpericardial effusion with local treatment and unstable control;
4. Active infection (including tuberculosis infection) requiring systemic anti-bacterial,antifungal, antiviral and other treatments during screening;
5. Recurrent symptomatic poorly controlled chronic obstructive pulmonary disease,extensive interstitial lung disease (including interstitial pneumonia, pulmonaryinterstitial fibrosis, etc.) at screening,
6. Extensive radiation pneumonitis, pulmonary embolism or active massive hemoptysis;Patients with severe gastrointestinal diseases or gastrointestinal disorders (such asgastrointestinal bleeding, gastrointestinal obstruction, unhealed peptic ulcer, immuneenteritis, ulcerative colitis, Crohn's disease, ischemic necrotizing enteritis,diarrhea > grade 1, other gastrointestinal diseases that may affect the tolerance ofchemotherapy) at screening;
7. Patients with the following cardiovascular and cerebrovascular diseases or history:
8. patients with unstable hypertension (systolic blood pressure ≥ 160 mmHg and/ordiastolic blood pressure ≥ 100 mmHg) or a history of hypertensive crisis orhypertensive encephalopathy;
9. patients with unstable severe arrhythmia;
10. patients with the following cardiovascular and cerebrovascular diseases within 6months: myocardial infarction, unstable angina, coronaryrevascularization/angioplasty, coronary artery bypass grafting, coronary arterystenting, New York Heart Association (NYHA) class ≥ 2 cardiac insufficiency,severe unstable arrhythmia, deep vein thrombosis, pulmonary embolism history,active cerebral infarction, active cerebral hemorrhage;
11. Patients with any of the following conditions:
12. positive hepatitis B virus surface antigen (HBsAg) test,And peripheral bloodhepatitis B virus deoxyribonucleic acid (HBV-DNA) detection ≥ 1000 IU/mL;
13. hepatitis C virus antibody (HCV-Ab) positive, and hepatitis C virus ribonucleicacid (HCV-RNA) detection ≥ 100 IU/mL;
14. human immunodeficiency virus antibody (HIV-Ab) detection positive;
15. Other malignancies within 5 years before screening (except cured stage IB or lowercervical cancer, non-invasive basal cell, scale-cell skin cancer or resectablecarcinoma in situ);
16. Patients with primary diseases of other important organs (such as nervous system,cardiovascular and cerebrovascular system, urinary system, digestive system,respiratory system or metabolic endocrine system diseases) and the researchers believethat it is not suitable for participants, or for other reasons the researchers believethat it is not suitable for participants;
17. Previous treatment with irinotecan or irinotecan modified, topotecan or othertopoisomerase I inhibitors;
18. Known hypersensitivity to irinotecan hydrochloride liposomes or its excipients,structurally similar compounds (such as camptothecin compounds), other liposomaldrugs, and topotecan;
19. Those who have been vaccinated with live vaccine or live attenuated vaccine beforescreening;
20. Patients who have received systemic anti-tumor therapy in 4 weeks beforerandomization;
21. Patients who have applied other clinical trial drugs/devices before randomization;
22. Patients who have used strong inducers or strong inhibitors of CYP3A4 and stronginhibitors of UGT1A1 before randomization;
23. Adverse reactions caused by previous anti-tumor treatment are not recovered to grade 1or lower (except alopecia and peripheral neuropathy);
24. History of drug abuse, drug abuse and/or alcoholism;
25. Pregnant or lactating women;
26. Other conditions (including but not limited to unstable nervous system diseases andmental disorders) that are considered unsuitable for inclusion in this trial by theinvestigator.