A Study of TQB2450 Injection Combined With Stereotactic Body Radiation Therapy (SBRT) in Subjects With Advanced Oligometastatic Non-Small Cell Lung Cancer
A Open-label, Single-arm, Phase II Study of TQB2450 Injection Combined With Stereotactic Body Radiation Therapy (SBRT) in Subjects With Advanced Oligometastatic Non-Small Cell Lung Cancer
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hongqing Zhuang, Doctor
- Número de teléfono: 010-82264931
- Correo electrónico: hongqingzhuang@163.com
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana, 100191
- Peking University Third Hospital
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Contacto:
- Hongqing Zhuang, Doctor
- Correo electrónico: hongqingzhuang@163.com
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Investigador principal:
- Hongqing Zhuang, Doctor
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Beijing, Beijing, Porcelana, 100142
- Beijing Cancer Hospital
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Contacto:
- Huiming Yu, Doctor
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Investigador principal:
- Huiming Yu, Doctor
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Shanghai
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Shanghai, Shanghai, Porcelana, 200040
- Huashan Hospital Fudan University
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Contacto:
- Enmin Wang, Doctor
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Investigador principal:
- Enmin Wang, Doctor
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Tianjin
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Tianjin, Tianjin, Porcelana, 300060
- Tianjin Medical University Cancer Institute and Hospital
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Contacto:
- Zhiyong Yuan, Doctor
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Investigador principal:
- Zhiyong Yuan, Doctor
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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:
1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥ 3 months.
2. Histologically or pathologically confirmed advanced non-small cell lung cancer.
3. Primary lesion controlled oligometastatic patients, the number of metastatic lesions ≤ 5, and has at least one measurable lesion.
4. Has received standard first-line chemotherapy, intolerable or inappropriate to the chemotherapy.
5. Adequate organ system function. 6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.
7.Understood and Signed an informed consent form.
Exclusion Criteria:
1. Has used against PD-1, PD-L1 and other related immunotherapeutic drugs. 2.Has mutations in (epidermal growth factor receptor)EGFR, (anaplastic lymphoma kinase)ALK, (c-ros oncogene 1 receptor kinase)ROS1 or T790M and not resistant to targeted drug.
3. Has severe hypersensitivity reaction to other monoclonal antibodies. 4. Has diagnosed and/or treated additional malignancy within 5 years prior to the first administration.Exceptions include cured basal cell carcinoma of skin and carcinoma in situ of cervix.
5. Has any active autoimmune disease or a history of autoimmune disease. 6. Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration.
7. (Magnetic Resonance Imaging)MRI examination found meningeal metastases and cannot be controlled by stereotactic radiotherapy.
8. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.
9. Has any severe and/or uncontrolled disease. 10. Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration.
11. According to the judgement of the researchers, there are other factors that may lead to the termination of 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: TQB2450+SBRT
SBRT three days before TQB2450.
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TQB2450 1200mg administered IV on Day 1 of each 21-day cycle.
Give according to the location of the lesion and clinical condition.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Progression-Free Survival (PFS)
Periodo de tiempo: Baseline up to 96 weeks
|
PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.
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Baseline up to 96 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Objective response rate (ORR)
Periodo de tiempo: Baseline up to 96 weeks
|
Percentage of subjects achieving complete response (CR) and partial response (PR).
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Baseline up to 96 weeks
|
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Overall survival (OS)
Periodo de tiempo: Baseline up to 96 weeks
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OS defined as the time from the first dose to death from any cause.
Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
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Baseline up to 96 weeks
|
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Disease control rate（DCR）
Periodo de tiempo: Baseline up to 96 weeks
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Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
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Baseline up to 96 weeks
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Colaboradores e Investigadores
Patrocinador
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TQB2450-II-05
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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