Extensive-stage Small Cell Lung Cancer
Conditions
Interventions
Experimental group:Lomustine combined with anlotinib
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 75 years old, gender not restricted; 2. Diagnosed with small cell lung cancer (SCLC) through pathological histology or cytology, and meeting the criteria for extensive-stage classification (VA-SLC staging by the American Veterans Lung Cancer Association); 3. Previously received at least 2 lines of systemic treatment; 4. At least one measurable lesion (according to the RECIST 1.1 standard); 5. ECOG performance status score: 0 - 1; 6. Normal organ function, meeting the following criteria: Blood routine: Absolute neutrophil count (ANC) >= 1.5 × 10^9/L, platelets (PLT) >= 100 × 10^9/L, hemoglobin (Hb) >= 90 g/L; Liver and kidney function: Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) = 60 mL/min/1.73m^2; Coagulation function: International normalized ratio (INR) = 3 months; 8. Voluntarily signed informed consent form and able to comply with the requirements of the research protocol to complete follow-up.
Exclusion criteria
Exclusion criteria: 1.Previous treatment with lomustine, anlotinib, or other similar anti-angiogenic TKIs. 2.Uncontrolled central nervous system (CNS) metastases (e.g., unstable or symptomatic brain metastases, or those requiring ongoing glucocorticoid therapy). 3.Active bleeding or high bleeding risk (e.g., history of massive gastrointestinal hemorrhage or cerebral hemorrhage within the past 6 months, or presence of unhealed wounds or ulcers). 4.Uncontrolled hypertension (systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg) or severe cardiovascular diseases (e.g., myocardial infarction, severe arrhythmia, heart failure within the past 6 months). 5.Active infection (such as pneumonia, sepsis) or uncontrolled systemic diseases (such as uncontrolled diabetes, autoimmune diseases). 6.Pregnant or lactating females. Female participants must use effective contraception during treatment and for 6 months after the last dose of study treatment; male participants must use effective contraception during treatment and for 3 months after the last dose of study treatment. 7.History of other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and other cured malignancies. 8.Known hypersensitivity to lomustine, anlotinib, or any excipient in their formulations. 9.Any other condition deemed inappropriate for participation in this study by the investigator (e.g., mental disorders, inability to comply with follow-up procedures).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator-Assessed Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Adverse Event (AE);Disease Control Rate (DCR);Progression free survival;Quality of Life Score(QOL Score); | — |
Countries
China
Contacts
Public ContactYayi He
Shanghai Pulmonary Hospital
Outcome results
None listed