Lomustine Combined With Anlotinib as Interventional Therapy for Extensive-stage Small Cell Lung Cancer Resistant to Second-line and Above Treatment (Aurora003)
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
1: Aged 18-75 years, without gender restriction.
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.
3: Has received at least two lines of prior systemic antitumor therapy.
4: Has at least one measurable lesion as defined by RECIST 1.1 criteria.
5: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
6: Adequate organ function meeting the following criteria: Hematological function: Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; platelet count (PLT) ≥ 100×10⁹/L; hemoglobin (Hb) ≥ 90 g/L. 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/min/1.73m². Coagulation function: International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
7: Expected survival time ≥ 3 months.
8: Voluntarily signs the informed consent form and is willing and able to comply with the study protocol and follow-up requirements.
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: lomustine combined with anlotinib
Oral lomustine 60 mg/m² 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.
|
Oral lomustine 60 mg/m² once daily on day 1, every 6 weeks
Oral administration, initial dose 12 mg, 10 mg or 8 mg once daily on days 1-14 of every 3-week cycle
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Objective Response Rate
Periodo de tiempo: Baseline at screening, after every 2 treatment cycles (each cycle is 21 days), end of treatment, up to disease progression, assessed up to approximately 24 months
|
Investigator-assessed ORR per RECIST 1.1 in ES-SCLC patients treated with Lomustine combined with anlotinib
|
Baseline at screening, after every 2 treatment cycles (each cycle is 21 days), end of treatment, up to disease progression, assessed up to approximately 24 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evento Adverso (AE)
Periodo de tiempo: Desde la firma del consentimiento informado hasta la finalización del estudio y el seguimiento de seguridad, evaluado durante aproximadamente 24 meses
|
Registrar todos los eventos médicos desfavorables nuevos o que empeoran, su grado y calcular la incidencia según CTCAE 5.0
|
Desde la firma del consentimiento informado hasta la finalización del estudio y el seguimiento de seguridad, evaluado durante aproximadamente 24 meses
|
|
Tasa de Control de la Enfermedad (TCE)
Periodo de tiempo: Período de tiempo: Línea de base y después de cada 2 ciclos de tratamiento (cada ciclo es de 21 días), hasta la progresión de la enfermedad, la muerte o la retirada del estudio, lo que ocurra primero, evaluado hasta aproximadamente 24 meses
|
Según RECIST 1.1, proporción de sujetos que logran CR, PR o enfermedad estable (SD) en la población total inscrita
|
Período de tiempo: Línea de base y después de cada 2 ciclos de tratamiento (cada ciclo es de 21 días), hasta la progresión de la enfermedad, la muerte o la retirada del estudio, lo que ocurra primero, evaluado hasta aproximadamente 24 meses
|
|
progression free survival
Periodo de tiempo: Date of first study treatment to date of disease progression or death from any cause, last follow-up, assessed up to approximately 24 months
|
Time from first treatment to disease progression or death from any cause, whichever occurs first
|
Date of first study treatment to date of disease progression or death from any cause, last follow-up, assessed up to approximately 24 months
|
|
Quality of Life Score（QOL Score）
Periodo de tiempo: At baseline, every 6 weeks during treatment until disease progression or death，assessed up to approximately 24 months
|
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) was adopted for patient self-assessment.
The scale consists of 30 items, including 5 functional scales, 9 symptom scales and 1 global health status / quality of life scale.
Each item is scored on a 1-4 Likert scale, and all scale scores are standardized to a range of 0-100.
Higher scores in functional and global quality of life scales and lower scores in symptom scales indicate better quality of life and health status of patients.
|
At baseline, every 6 weeks during treatment until disease progression or death，assessed up to approximately 24 months
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026LY0102
- MR-31-26-032631 (Otro identificador: National Medical Research Registration and Filing System)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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