- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03589950
Anlotinib Plus Chemotherapy for Patients With Advanced Non-small Cell Lung Cancer
A Parallel Control, Exploratory Trial to Compare Anlotinib Plus Chemotherapy Versus Chemotherapy as Second-line Treatment in Subjects With Advanced Non-small Cell Lung Cancer
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: xiaodong jiang, MD
- Número de teléfono: 18961326201
- Correo electrónico: jxdysy1970@163.com
Ubicaciones de estudio
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Jiangsu
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Lianyungang, Jiangsu, Porcelana, 222002
- The Affiliated Lianyungang Hospital of Xuzhou Medical University
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Contacto:
- xiaodong jiang, MD
- Número de teléfono: 18961326201
- Correo electrónico: jxdysy1970@163.com
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Sub-Investigador:
- lijun liang, MM
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Sub-Investigador:
- yixuan wen, MM
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age:18~75 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 -2
- Subjects with histologically or cytologically confirmed locally advanced or advanced NSCLC who have previously received one lines chemotherapy, EGFR TKI or ALK inhibitor (whom with EGFR or ALK mutation but not with T790 M positive) treatment before participating;
- Subjects with at least one measurable lesion as defined by RECIST (version 1.1),which is confirmed by computed tomography (CT) scan or MRI .
- Subjects without brain metastases or asymptomatic brain metastases, and not needing for dehydrating agents or corticosteroids to control intracranial symptoms;
- Survival expectation ≥ 3 months;
- The main organ function is normal;
- Females of childbearing potential must be a pregnancy test in 7 days before participating ( including serum or urine), and the results were negative.
- Subjects provided written informed consent before participating, willing and able to comply with all aspects of the protocol
Exclusion Criteria:
1. Small Cell Lung Cancer; 2. Subjects with symptomatic brain metastases; 3. Survival expectation < 3 months; 4. examined as positive in EGFR&ALK mutation detection and never take the treatment of TKIs 5. Blood transfusion is required in the first dose of drug treatment within 14 days ; 6. The interval of subjects had received chemotherapy, biotherapy, radiotherapy or other anticancer therapies in the first dose of drug treatment within 21 days(excluding palliative radiotherapy); 7. The risk of active bleeding; 8. Subjects with uncontrolled blood pressure with medication (140/90 mmHg) 9. Laboratory values and organ functions : (1)Hematologic insufficiency:
- Hemoglobin (Hb)<8.5 g/dL,
- Absolute neutrophil count (ANC)≤1.5×109/L,
- Platelet count (PLT)< 100×109/L; (2)Insufficient liver function:
- Bilirubin > 1.5×the upper limit of normal (ULN)
- Alanine aminotransferase (ALT), or Aspartate aminotransferase (AST) >3.0×(ULN), When liver metastases,Bilirubin > 1.5×ULN, ALT or AST >5.0×(ULN.
- serum creatinine ≤1.0×(ULN), or creatinine clearance > 50 mL/min( calculated per the Cockcroft and Gault formula) (3) Subjects with positive for HBV surface antigen ( HBsAg)or anti-hcv (4)Subjects with Interstitial lung disease (5)Insufficient renal function: serum creatinine≥ 1.5×(ULN), or creatinine clearance <60 mL/min
10. impairment of heart function: (1)Left ventricular ejection fraction (LVEF) <45% (LVEF evaluation is not required for subjects have no history of congestive heart failure), (2)Unstable angina, (3)Severe arrhythmia, (4)NYHA III or IVgrade of congestive heart failure, (5) Subjects with myocardial infarction within the last 12 months before entering the trial, (6)Pericardial effusion, 11. Subjects with liver fibrosis or hepatic cirrhosis 12. (1)Subjects with other active malignancy (except for definitively treated non melanoma skin cancer,carcinoma in-situ of the cervix,or other cancers that are treated with curative treatment and have no signs of recurrence for at least 5 years ) , (2)Subjects with dysphagia,malabsorption,chronic gastrointestinal diseases,or other medical history may hinder compliance and / or experimental drug absorption, 13. Subjects with major surgery in the first dose of drug treatment within 28 days, 14. Subjects with positive unknown human immunodeficiency virus.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Anlotinib plus chemotherapy
Anlotinib (12mg QD PO d1-14, 21 days per cycle) + Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d/S-1 (80-120mg/day,depending on body surface area; days 1-28 in a 6-week cycle)
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Anlotinib (12mg QD PO d1-14, 21 days per cycle), Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d/S-1 (80-120mg/day,depending on body surface area; days 1-28 in a 6-week cycle)
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Comparador activo: Chemotherapy
Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d/S-1 (80-120mg/day,depending on body surface area; days 1-28 in a 6-week cycle)
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Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d/S-1 (80-120mg/day,depending on body surface area; days 1-28 in a 6-week cycle)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
PFS
Periodo de tiempo: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
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progression-free survival
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
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DCR
Periodo de tiempo: Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
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Disease Control Rate
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Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Sistema operativo
Periodo de tiempo: Desde la aleatorización hasta la muerte (hasta 24 meses)
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Sobrevivencia promedio
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Desde la aleatorización hasta la muerte (hasta 24 meses)
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ORR
Periodo de tiempo: each 21 days up to the toxicity or PD (up to 24 months)
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Objective Response Rate
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each 21 days up to the toxicity or PD (up to 24 months)
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Quality of life score
Periodo de tiempo: each 21 days up to the toxicity or PD (up to 24 months)
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Quality of life score
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each 21 days up to the toxicity or PD (up to 24 months)
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Safety
Periodo de tiempo: each 21 days up to the toxicity or PD (up to 24 months)
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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each 21 days up to the toxicity or PD (up to 24 months)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Han B, Li K, Zhao Y, Li B, Cheng Y, Zhou J, Lu Y, Shi Y, Wang Z, Jiang L, Luo Y, Zhang Y, Huang C, Li Q, Wu G. Anlotinib as a third-line therapy in patients with refractory advanced non-small-cell lung cancer: a multicentre, randomised phase II trial (ALTER0302). Br J Cancer. 2018 Mar 6;118(5):654-661. doi: 10.1038/bjc.2017.478. Epub 2018 Feb 13.
- Sun Y, Niu W, Du F, Du C, Li S, Wang J, Li L, Wang F, Hao Y, Li C, Chi Y. Safety, pharmacokinetics, and antitumor properties of anlotinib, an oral multi-target tyrosine kinase inhibitor, in patients with advanced refractory solid tumors. J Hematol Oncol. 2016 Oct 4;9(1):105. doi: 10.1186/s13045-016-0332-8.
- Xie C, Wan X, Quan H, Zheng M, Fu L, Li Y, Lou L. Preclinical characterization of anlotinib, a highly potent and selective vascular endothelial growth factor receptor-2 inhibitor. Cancer Sci. 2018 Apr;109(4):1207-1219. doi: 10.1111/cas.13536. Epub 2018 Mar 25.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Anlo01
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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