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- Ensayo clínico NCT07633873
SYS6010 Combined With Enlonstobart Versus Immunotherapy+ Platinum-based Chemotherapy for Patients With PD-L1-Positive Locally Advanced or Metastatic NSCLC(SYNSTAR 04)
9 de junio de 2026 actualizado por: CSPC Megalith Biopharmaceutical Co.,Ltd.
An Open-label, Multicenter Randomized Phase III Study of SYS6010 Combined With Enlonstobart Versus Immunotherapy+ Platinum-based Chemotherapy as First-Line Treatment for Patients With PD-L1-Positive Locally Advanced or Metastatic NSCLC
This study was an open-label, multi-center, randomized phase III study to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart versus Immunotherapy+ Platinum-based chemotherapy as First-Line treatment for patients with PD-L1-Positive locally advanced or metastatic NSCLC.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
500
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Clinical Trials Information Group officer
- Número de teléfono: 031169085587
- Correo electrónico: ctr-contact@cspc.cn
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Aged 18-75 (inclusive) years old, male or females;
- Participants with pathologically confirmed locally advanced or metastatic NSCLC. Including participants with stage IIIB or IIIC according to the 9th edition of AJCC staging who are not suitable for surgical resection or radical chemoradiotherapy, or participants with stage IV NSCLC
- Participants who have not previously received systemic anti-tumor treatment. Those who have previously received adjuvant/neoadjuvant therapy will be allowed for inclusion if disease progression occurs 12 months after the end of treatment.
- EGFR mutation negative and ALK fusion negative
- Participants with PD-L1 TPS≥1% according to centralized laboratory test
- At least one measurable lesion confirmed by CT or MRI scan according to RECIST v1.1 criteria
- ECOG performance status of 0-1;
- Life expectancy ≥ 3 months;
- Major organ function must meet the criteria within 7 days prior to the first dose of the study intervention
- Women of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose. Participants must agree to use effective contraception from the time of signing the informed consent form until 7 months after the last dose; during this period, women should not be breastfeeding, and men should avoid donating sperm;
- Voluntarily participate in this clinical study, understand the study procedures, and be able to sign a written informed consent form.
Exclusion Criteria:
- Histology or cytology of the tumor confirms the presence of combined small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma;
- Participants with ROS1/RET/NTRK fusions, MET exon 14 skipping mutation, or BRAF V600E mutation.
- Participants with meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active CNS metastasis. Patients with supratentorial and/or cerebellar metastasis (i.e., without mesencephalon, pons, or medulla involvement) who have received local treatment, have achieved stability for at least 2 weeks prior to the first dose of the study intervention (imaging shows no new brain metastasis or enlargement of existing brain metastasis, and all neurologic symptoms have stabilized or returned to normal), and do not require corticosteroid therapy or are receiving prednisone at a daily dose of ≤10 mg or equivalent doses of other corticosteroids, can participate in the study;
- Participants with a history of other malignant tumors within 3 years prior to the first dose of the study intervention, except for the following conditions: cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, and cervical carcinoma in situ, etc.;
- Participants who are known to be allergic to any component of SYS6010, Enlonstobart, Tislelizumab or to humanized monoclonal antibody products or ; Paclitaxel/Carboplatin/ Pemetrexed/Cisplatin.
- Previously treated with topoisomerase I inhibitor toxin ADC therapy
- AEs caused by prior anti-tumor treatment have not recovered to ≤ Grade 1 (excluding Grade 2 alopecia and other toxicities judged by the investigator to have no safety risk) according to NCI-CTCAE v6.0; Participants who experienced ≥ grade 3 irAEs during previous treatment, or who permanently discontinued medication due to irAEs
- Patients who have not met the corresponding washout period requirements for the medications or treatments should be excluded;
- History of severe cardiovascular or cerebrovascular disease within 6 months prior to the first dose of the study intervention\
- Patients who have a history of ILD/non-infectious pneumonitis treated with corticosteroids in the past, currently have ILD/non-infectious pneumonitis, for whom imaging examinations at screening cannot rule out ILD/non-infectious pneumonitis, or whose pulmonary function test indicates severe ventilatory dysfunction and/or decreased diffusion capacity;
- Presence of severe infections within 4 weeks prior to the first dose of the study intervention, including but not limited to bacteraemia requiring hospitalisation, severe pneumonia, active pulmonary tuberculosis infection, etc.; presence of active infections requiring systemic antibiotics within 2 weeks prior to the first dose of the study intervention;
- Participants with active autoimmune diseases or a history of autoimmune diseases (such as ulcerative colitis or Crohn's disease) are excluded, but participants with the following conditions are allowed to proceed to further enrollment screening: well-controlled type 1 diabetes and hypothyroidism that is well-controlled with only hormone replacement therapy.
- Pleural effusion or pericardial effusion requiring clinical intervention within 2 weeks prior to the first dose;
- Active HBV or HCV infection (hepatitis B surface antigen and/or hepatitis B core antibody positive and HBV DNA copies ≥ 1×10^4 copies/mL or ≥ 2000 IU/mL, HCV antibody positive and HCV RNA above the lower limit of detection of the analytical procedure). Note: For HBsAg-positive patients, it is recommended to start antiviral therapy before the first dose of the study intervention, nucleoside analogues are recommended, such as entecavir, tenofovir disoproxil;
- History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases), history of allogeneic stem cell or organ transplant;
- Other conditions that the investigator deem unsuitable for participation in this clinical study. Such as mental illness, uncontrolled or poorly controlled hypertension (defined as systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥95 mmHg after standardized antihypertensive treatment), and diabetes, etc.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: SYS6010 combined with Enlonstobart group
SYS6010 injection and Enlonstobart injection will be administrated on a 21-day cycle.
|
SYS6010 is Lyophilized powder for injection as an EGFR-ADC.
SYS6010 will be administered via intravenous infusion, Q3W, with 21 days as one treatment cycle, at a dose of 4.5 mg/kg.
Enlonstobart is arecombinant human anti-PD-1 monoclonal antibody injection,and will be administered by intravenous infusion, Q3W, with 21 days as one treatment cycle at a dosage of 360 mg.
Otros nombres:
|
|
Comparador activo: Tislelizumab+ Platinum-based chemotherapy
For squamous NSCLC, Tislelizumab +Paclitaxel+Carboplatin were recommended to be administrated on a 21-day cycle.
For nonsquamous NSCLC, Tislelizumab + Pemetrexed + Cisplatin or Carboplatin were recommended to be administrated on a 21-day cycle.
|
Tislelizumab is a marketed recombinant human anti-PD-1 monoclonal antibody injection, and will be administered by intravenous infusion, Q3W, with 21 days as one treatment cycle at a dosage of 200 mg.
Otros nombres:
Paclitaxel+Carboplatin or Pemetrexed + Cisplatin/Carboplatin are widely accepted and common chemotherapy medication. For squamous NSCLC, Paclitaxel+Carboplatin were recommended to be administrated on a 21-day cycle. For nonsquamous NSCLC, Pemetrexed + Cisplatin or Carboplatin were recommended to be administrated on a 21-day cycle.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Progression Free Survival (PFS) assessed by IRC
Periodo de tiempo: 2 years
|
2 years
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Supervivencia global (SG)
Periodo de tiempo: 2 años
|
2 años
|
|
ORR assessed by investigators and IRC
Periodo de tiempo: 1.5years
|
1.5years
|
|
DoR assessed by investigators and IRC
Periodo de tiempo: 1.5years
|
1.5years
|
|
The Proportion of ADAanti-drug antibody positive of SYS6010 and Enlonstobart
Periodo de tiempo: 1.5years
|
1.5years
|
|
The severity and frequency of Adverse Event (AE)and Serious Adverse Event (SAE) assessed by CTCAE v6.0.
Periodo de tiempo: 2 years
|
2 years
|
|
Tmax of SYS6010 and Enlonstobart
Periodo de tiempo: 1.5 years
|
1.5 years
|
|
The Scale of Quality of Life assessed by participants
Periodo de tiempo: 2 years
|
2 years
|
|
Cmax of SYS6010 and Enlonstobart
Periodo de tiempo: 1.5 years
|
1.5 years
|
|
AUC0-504h of SYS6010 and Enlonstobart
Periodo de tiempo: 1.5 years
|
1.5 years
|
|
t1/2 of SYS6010 and Enlonstobart
Periodo de tiempo: 1.5 years
|
1.5 years
|
|
CL of SYS6010 and Enlonstobart
Periodo de tiempo: 1.5 years
|
1.5 years
|
|
Vz of SYS6010 and Enlonstobart
Periodo de tiempo: 1.5 years
|
1.5 years
|
|
DCR assessed by investigators and IRC
Periodo de tiempo: 1.5 years
|
1.5 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
2 de junio de 2026
Finalización primaria (Estimado)
30 de septiembre de 2027
Finalización del estudio (Estimado)
30 de mayo de 2029
Fechas de registro del estudio
Enviado por primera vez
31 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de junio de 2026
Publicado por primera vez (Actual)
8 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Neoplasias Pulmonares
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Carcinoma de pulmón de células no pequeñas
- Aminoácidos, péptidos y proteínas
- Químicos orgánicos
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Químicos inorgánicos
- Compuestos de cloro
- Compuestos de nitrógeno
- Complejos de coordinación
- Guanina
- Hipoxantino
- Purinones
- Purinas
- Glutamatos
- Aminoácidos, ácido
- Aminoácidos
- Aminoácidos, dicarboxílico
- Compuestos de platino
- Pemetrexed
- Carboplatino
- Cisplatino
- tislelizumab
- Protocolo CP
- Protocolo TP
- AP protocol 1
Otros números de identificación del estudio
- SYS6010-022
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .