- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07802821
A Study Comparing QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy in Participants Wih Treatment-naïve Extensive-Stage Small Cell Lung Cancer
A Phase III, Randomized, Controlled, Open-label Clinical Study to Compare the Efficacy and Safety of QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy as First-line Treatment in Participants With Extensive-stage Small Cell Lung Cancer
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Haiying Yu, Bachelor
- Número de teléfono: +86-17821799566
- Correo electrónico: haiying.yu@qilu-pharma.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age ≥18 years.
- Participants with histologically or cytologically confirmed Extensive-Stage Small Cell Lung Cancer (ES-SCLC) per the Veterans Administration Lung Cancer Study Group (VALG) staging system.
- No prior systemic treatment for ES-SCLC.
- At least one extracranial measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, without deterioration within 2 weeks prior to the first dose of study treatment.
- Life expectancy ≥12 weeks.
- Has adequate organ function.
- Male and female participants of reproductive/childbearing potential must agree to avoid pregnancy.
- Voluntarily sign the written informed consent form and comply with the protocol requirements.
Exclusion Criteria:
Has received or undergoing any of the following treatment:
Previous or current treatment with B7-H3 targeted therapy. Previous or current treatment with topoisomerase I inhibitors.
- Participants with transformed Non-Small Cell Lung Cancer (NSCLC), epidermal growth factor receptor (EGFR) mutation-positive NSCLC that has transformed to SCLC, or mixed SCLC-NSCLC histology.
- Presence with active brain metastases, leptomeningeal metastasis, brainstem metastasis or spinal cord compression.
- Radiotherapy with a limited field of radiation within 2 weeks prior to the study treatment; more than 30% of the bone marrow irradiation or large-scale radiotherapy within 4 weeks prior to study treatment.
- Major surgery within 4 weeks prior to the study treatment.
- Unresolved AEs ≥ Grade 2 (CTCAE v6.0) from prior therapy.
- Previous or concurrent primary malignancies.
- History of severe heart disease or cerebrovascular disease.
- History of Severe or uncontrolled hypertension or diabetes mellitus.
- Severe infection within 4 weeks prior to study treatment; or uncontrolled active infection at screening.
- Known or suspected interstitial lung disease/non-infectious pneumonitis; or other moderate to severe pulmonary diseases that significantly impair respiratory function and may interfere with the detection or management of drug-related pulmonary toxicity.
- Known history of pre-existing or newly diagnosed autoimmune disease.
- History of severe neuropathy or mental disorders.
- History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to study drugs or any components of the study drugs.
- Unlikely to comply with study procedures and requirements in the opinion of the investigator.
- Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments.
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: QLC5508 in combination with QL2107
|
QLC5508 will be administered intravenously once every 3 weeks.
Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first.
QL2107 will be administered intravenously once every 3 weeks.
Treatment will continue until disease progression or unacceptable toxicity.
The maximum treatment duration for QL2107 will be 2 years.
|
|
Comparador activo: Tislelizumab in Combination with Platinum-based Chemotherapy
|
Tislelizumab will be administered intravenously once every 3 weeks.
Treatment will continue until disease progression or unacceptable toxicity.
The maximum treatment duration for Tislelizumab will be 2 years.
Carboplatin will be administered intravenously once every 3 weeks.
Carboplatin treatment will be administered for up to 4 cycles.
Cisplatin will be administered intravenously once every 3 weeks.
Cisplatin treatment will be administered for up to 4 cycles.
Etoposide will be administered intravenously once every 3 weeks.
Etoposide treatment will be administered for up to 4 cycles.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall survival (OS)
Periodo de tiempo: Up to approximately 36 months
|
OS is defined as the duration from the date of randomization to the date of death due to any cause.
|
Up to approximately 36 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Progression-free survival (PFS)
Periodo de tiempo: Up to approximately 36 months
|
PFS is defined as the duration from the date of randomization to the date of first documented progressive disease (PD) based on investigator assessment, or death from any cause, whichever occurs first.
|
Up to approximately 36 months
|
|
Objective response rate (ORR)
Periodo de tiempo: Up to approximately 36 months
|
ORR is defined as the percentage of participants achieved complete response or partial response as assessed according to RECIST v1.1 criteria.
|
Up to approximately 36 months
|
|
Duration of response (DOR)
Periodo de tiempo: Up to approximately 36 months
|
DOR is defined as the duration from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first.
|
Up to approximately 36 months
|
|
Disease control rate (DCR)
Periodo de tiempo: Up to approximately 36 months
|
DCR is defined as the percentage of participants achieved complete response, partial response, or stable disease as assessed according to RECIST v1.1 criteria.
|
Up to approximately 36 months
|
|
6-month PFS rate
Periodo de tiempo: Up to approximately 36 months
|
The 6-month PFS rate is defined as the proportion of participants who have not experienced PD and who are alive at 6 months from the date of randomization.
|
Up to approximately 36 months
|
|
12-month PFS rate
Periodo de tiempo: Up to approximately 36 months
|
The 12-month PFS rate is defined as the proportion of participants who have not experienced PD and who are alive at 12 months from the date of randomization.
|
Up to approximately 36 months
|
|
12-month OS rate
Periodo de tiempo: Up to approximately 36 months
|
The 12-month OS rate is defined as the proportion of participants who are alive at 12 months from the date of randomization.
|
Up to approximately 36 months
|
|
24-month OS rate
Periodo de tiempo: Up to approximately 36 months
|
The 24-month OS rate is defined as the proportion of participants who are alive at 24 months from the date of randomization.
|
Up to approximately 36 months
|
|
Treatment Emergent Adverse Event (TEAE)
Periodo de tiempo: Up to approximately 36 months
|
TEAEs are defined as any adverse event (AE) that occurs after the initiation of study treatment, or any pre-existing condition that worsens in severity or frequency after the initiation of study treatment, regardless of the causal relationship to the study treatment. TEAEs will be graded and summarized by type, frequency, and severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 6.0. |
Up to approximately 36 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
- 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 pequeñas
- Químicos orgánicos
- Hidrocarburos
- Hidrocarburos, cíclico
- Carbohidratos
- Podoflotoxina
- Tetrahidronaftalenos
- Naftalenos
- Hidrocarburos aromáticos policíclicos
- Hidrocarburos, aromáticos
- Compuestos policíclicos
- Glucósidos
- Glucósidos
- Químicos inorgánicos
- Compuestos de cloro
- Compuestos de nitrógeno
- Complejos de coordinación
- Compuestos de platino
- Etopósido
- Carboplatino
- Cisplatino
- tislelizumab
Otros números de identificación del estudio
- QLC5508-304
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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