Erlotinib as Neoadjuvant Treatment in Patients With Stage ⅢA N2 NSCLC With Activating EGFR Mutation. (ML25444)
A Single Arm, One Center, Phase Ⅱ Study of Erlotinib as Neoadjuvent Treatment in Patients With Endobronchial Ultrasound Confirmed Stage ⅢA N2 NSCLC With EGFR Mutation in Exon 19 or 21
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Screening phase:
Patients clinically diagnosed as stage ⅢA N2 lung caner by CT technique will be pathologically proven as NSCLC with N2 by EBUS. The pathology specimen will be detected EGFR mutation by DNA sequencing. The patients with EGFR mutation in exon 19 or 21 will be enrolled in this study.
Neoadjuvant treatment phase:
Patient will receive erlotinib 150mg/day. Treatment will be scheduled to continue for a total of 8 weeks or disease progression or unacceptable toxicities.
Surgery treatment phase:
Tumor response will be evaluated with CT scan after 8 weeks of induction treatment. The patients with responsive disease considered to be technique resectable will undergo resection.
Post-surgery phase:
It is the discretion of the investigator whether the patient is a candidate for post-operative treatment which is considered to be in the best interest of the patients. It is recommended that patients with positive margins or residual tumor after surgery should receive radiation therapy. Patients after surgery will receive long-term follow-up including chest CT scan every 3 months for up to 2 years.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Shanghai
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Shanghai, Shanghai, Porcelana, 200030
- Shanghai Chest Hospital
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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:
Written informed consent provided. Males or females aged ≥18 years. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
Stage IIIA N2 NSCLC according to the pathological evidence of endobronchial ultrasound(EBUS).
The biopsy specimen shows EGFR mutation in exon 19 or 21 by DNA sequencing. Measurable disease must be characterized according to RECIST criteria: measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20cm with conventional techniques (PE, CT, XR, MRI) or as ≥ 10cm with spiral scan.
ECOG performance status 0-1. Life expectancy ≥12 weeks.
Female subjects should not be pregnant or breast-feeding.
Exclusion Criteria:
The biopsy specimen shows EGFR wildtype in exon 19 or 21 by DNA sequencing. Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).
Known hypersensitivity to Tarceva or any of its recipients.
Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the subject at high risk for treatment-related complications.
Sexually active males and females(of childbearing potential) unwilling to practice contraception during the study.
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 |
|---|---|
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Experimental: Erlotinib
Single-arm
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erlotinib 150mg/d continuously for 56 days
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
radical resection rate
Periodo de tiempo: operation after effective neoadjuvant treatment of tarceva for 56 days
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To evaluate radical resection rate of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ⅢA N2 NSCLC with EGFR mutation in exon 19 or 21.
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operation after effective neoadjuvant treatment of tarceva for 56 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pathological Complete Remission
Periodo de tiempo: operation after effective neoadjuvant treatment of tarceva for 56 days
|
To evaluate Pathological Complete Remission (pCR) rate of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ⅢA N2 NSCLC with EGFR mutation in exon 19 or 21.
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operation after effective neoadjuvant treatment of tarceva for 56 days
|
|
Objective Response Rate
Periodo de tiempo: Objective Response Rate measured by RECIST criteria in ITT population treated by erlotinib
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To evaluate Objective Response Rate (ORR) of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ⅢA N2 NSCLC with EGFR mutation in exon 19 or 21.
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Objective Response Rate measured by RECIST criteria in ITT population treated by erlotinib
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disease free survival
Periodo de tiempo: From surgery to disease relapse or death
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To evaluate disease free survival(DFS) of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ⅢA N2 NSCLC with EGFR mutation in exon 19 or 21.
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From surgery to disease relapse or death
|
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overall survival
Periodo de tiempo: From study treatment to death due to any cause
|
To evaluate overall survival(OS) of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ⅢA N2 NSCLC with EGFR mutation in exon 19 or 21.
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From study treatment to death due to any cause
|
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quality of life
Periodo de tiempo: During study treatment period
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To evaluate quality of life(QOL) of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ⅢA N2 NSCLC with EGFR mutation in exon 19 or 21.
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During study treatment period
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safety profile
Periodo de tiempo: For all the patient accepted study treatment
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To evaluate the safety profile using NCI CTC AE(version 4.0)
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For all the patient accepted study treatment
|
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explorative biomarkers
Periodo de tiempo: During study conduction period
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To evalutate the relationship between biomarker and Tarceva neoadjuvent treatment efficacy (TBD).
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During study conduction period
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Xiong L, Lou Y, Bai H, Li R, Xia J, Fang W, Zhang J, Han-Zhang H, Lizaso A, Li B, Gu A, Han B. Efficacy of erlotinib as neoadjuvant regimen in EGFR-mutant locally advanced non-small cell lung cancer patients. J Int Med Res. 2020 Apr;48(4):300060519887275. doi: 10.1177/0300060519887275. Epub 2019 Dec 29.
- Xiong L, Li R, Sun J, Lou Y, Zhang W, Bai H, Wang H, Shen J, Jing B, Shi C, Zhong H, Gu A, Jiang L, Shi J, Fang W, Zhao H, Zhang J, Wang J, Ye J, Han B. Erlotinib as Neoadjuvant Therapy in Stage IIIA (N2) EGFR Mutation-Positive Non-Small Cell Lung Cancer: A Prospective, Single-Arm, Phase II Study. Oncologist. 2019 Feb;24(2):157-e64. doi: 10.1634/theoncologist.2018-0120. Epub 2018 Aug 29.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
- Enfermedades de las vías respiratorias
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias Pulmonares
- Carcinoma de pulmón de células no pequeñas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Inhibidores de la proteína quinasa
- Clorhidrato de erlotinib
Otros números de identificación del estudio
- ML25444
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