[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643270":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":21,"locations":21,"responsibleParty":26,"collaborators":21,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":36,"eligibilityCriteria":37,"healthyVolunteers":32,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":21,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":21,"overallStatus":50,"whyStopped":21,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":21},{"fullName":5,"class":6},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"lomustine combined with anlotinib","EXPERIMENTAL","Oral lomustine 60 mg\u002Fm² once daily on day 1 every 6 weeks, combined with oral anlotinib. The initial dose of anlotinib is determined by the investigator, with optional doses of 12 mg, 10 mg or 8 mg once daily on days 1 to 14 every 3 weeks.",[13,14],"Drug: Lomustine","Drug: Anlotinib",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Lomustine","Oral lomustine 60 mg\u002Fm² once daily on day 1, every 6 weeks",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Anlotinib","Oral administration, initial dose 12 mg, 10 mg or 8 mg once daily on days 1-14 of every 3-week cycle",[9],{"type":27,"investigatorFullName":28,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"SPONSOR_INVESTIGATOR","Yayi He","Professor","100643270","phase-2-lomustine-combined-with-anlotinib-as-interventional-therapy-for-extensive-stage-small-cell-lung-cancer-resistant-to-second-line-and-above-treatment-100643270",false,"NCT07632209","Lomustine Combined With Anlotinib as Interventional Therapy for Extensive-stage Small Cell Lung Cancer Resistant to Second-line and Above Treatment","A Single-arm, Phase II Interventional Study to Evaluate the Efficacy and Safety of Lomustine Combined With Anlotinib in Patients With Extensive-stage Small Cell Lung Cancer Resistant to Second-line and Further Lines of Treatment","Aurora003","Inclusion Criteria:\n\n* 1: Aged 18-75 years, without gender restriction.\n\n  2: Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC), classified as extensive-stage disease according to the Veterans Administration Lung Study Group (VALSG) staging system.\n\n  3: Has received at least two lines of prior systemic antitumor therapy.\n\n  4: Has at least one measurable lesion as defined by RECIST 1.1 criteria.\n\n  5: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n\n  6: Adequate organ function meeting the following criteria: Hematological function: Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL; platelet count (PLT) ≥ 100×10⁹\u002FL; hemoglobin (Hb) ≥ 90 g\u002FL. Hepatic and renal function: Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5×ULN (≤ 5×ULN for patients with liver metastases); serum creatinine (Cr) ≤ 1.5×ULN; estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73m². Coagulation function: International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (APTT) ≤ 1.5×ULN.\n\n  7: Expected survival time ≥ 3 months.\n\n  8: Voluntarily signs the informed consent form and is willing and able to comply with the study protocol and follow-up requirements.\n\nExclusion Criteria:\n\n* 1: Previous treatment with lomustine, anlotinib, or other similar anti-angiogenic TKIs.\n\n  2: Uncontrolled central nervous system (CNS) metastases (e.g., unstable or symptomatic brain metastases, or those requiring ongoing glucocorticoid therapy).\n\n  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).\n\n  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).\n\n  5: Active infection (such as pneumonia, sepsis) or uncontrolled systemic diseases (such as uncontrolled diabetes, autoimmune diseases).\n\n  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.\n\n  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.\n\n  8: Known hypersensitivity to lomustine, anlotinib, or any excipient in their formulations.\n\n  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).","ALL","18 Years","75 Years",{"count":42,"type":43},46,"ESTIMATED","INTERVENTIONAL",[46],"PHASE2","This single-arm phase II study aims to evaluate the efficacy and safety of lomustine combined with anlotinib in patients with extensive-stage small cell lung cancer resistant to second-line and above systemic treatment.",[49],"SCLC, Extensive Stage","NOT_YET_RECRUITING","2026-06-02",{"date":53,"type":54},"2026-06-08","ACTUAL",{"date":56,"type":43},"2026-06",{"date":58,"type":43},"2028-12",{"name":28,"class":6}]