Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC) (DeLLphi-315)
16 de septiembre de 2026 actualizado por: Amgen
A Phase 3, Open-Label, Multicenter, Randomized Study of Subcutaneous vs Intravenous Tarlatamab in Participants With Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-315)
The primary objective of this study is to demonstrate non-inferiority in pharmacokinetic (PK) parameters of subcutaneous (SC) vs intravenous (IV) tarlatamab administration and to characterize the efficacy, safety, and tolerability of SC tarlatamab in participants with relapsed extensive-stage small-cell lung cancer (ES-SCLC) after platinum-based chemotherapy.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
400
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: Amgen Call Center
- Número de teléfono: 866-572-6436
- Correo electrónico: medinfo@amgen.com
Ubicaciones de estudio
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South Australia
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Elizabeth Vale, South Australia, Australia, 5112
- Reclutamiento
- Lyell McEwin Hospital
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Florida
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Orlando, Florida, Estados Unidos, 32806
- Reclutamiento
- University of Florida Health Cancer Center at Orlando Health
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Michigan
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Grand Rapids, Michigan, Estados Unidos, 49503
- Reclutamiento
- Cancer and Hematology Centers of Western Michigan
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68130
- Reclutamiento
- Oncology Hematology West PC
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Tokyo
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Bunkyo-ku, Tokyo, Japón, 113-8677
- Reclutamiento
- Tokyo Metropolitan Komagome Hospital
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Shanghai, Porcelana, 200433
- Reclutamiento
- Shanghai Pulmonary Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100142
- Reclutamiento
- Beijing Cancer Hospital
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Beijing, Beijing Municipality, Porcelana, 100020
- Reclutamiento
- Beijing Chaoyang Hospital
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Zurich, Suiza, 8091
- Reclutamiento
- Universitaetsspital Zuerich
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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:
- Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
- Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
- Participants who progressed or recurred following 1 platinum-based regimen.
- Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
- Minimum life expectancy of 12 weeks.
- Adequate organ function.
- History of central nervous system (CNS) metastases are allowed with considerations defined in the protocol.
Exclusion Criteria:
Disease Related
- Any previous diagnosis of non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation that has transformed to SCLC, or mixed SCLC and NSCLC histology, with exceptions defined in the protocol.
Other Medical Conditions
- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment.
- History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
- Current evidence or history of non-infectious pneumonitis/ILD (interstitial lung disease) that required steroids or other immunosuppressive treatment.
- History of other malignancy within the past 2 years, with exceptions defined in the protocol.
- Presence or history of viral infection based on criteria per protocol.
- History of solid organ transplantation.
- Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
- Known sensitivity or a contraindication to any of the products or components.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
Prior/Concomitant Therapy
- Prior systemic anticancer therapy within 30 days of enrolment
- Prior history of severe or life-threatening events from any immune-mediated therapy.
- Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment.
- Live and live-attenuated vaccines within 28 days prior to the start of study treatment.
- Receiving another anticancer therapy for a malignancy other than SCLC.
- More than 1 prior line of anticancer therapy for SCLC.
- Participation in a tarlatamab clinical trial or prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
- Treatment in an alternative investigational trial within 28 days prior to enrolment.
- History of allergy or hypersensitivity to similar products (eg, drugs with a similar chemical structure or other monoclonal antibody) or any excipient.
Other Exclusions
- Participants unable to have SC injections administered in the abdomen or thigh.
- Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements.
- History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Tarlatamab SC
Participants will receive Tarlatamab via SC injection
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Administered via SC injection or IV infusion
Otros nombres:
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Comparador activo: Tarlatamab IV
Participants will receive Tarlatamab via IV infusion
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Administered via SC injection or IV infusion
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Area Under the Curve From Cycle 2 Day 1 to Day 15 (AUC C2D1-D15) of Tarlatamab
Periodo de tiempo: From Cycle 2 Day 1 to Day 15 (each cycle is 28 days)
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From Cycle 2 Day 1 to Day 15 (each cycle is 28 days)
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Predose Concentration (Ctrough) of Tarlatamab
Periodo de tiempo: On Cycle 2 Day 15 (each cycle is 28 days)
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On Cycle 2 Day 15 (each cycle is 28 days)
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Supervivencia global (SG)
Periodo de tiempo: Hasta aproximadamente 4 años
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Hasta aproximadamente 4 años
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Respuestas al Cuestionario de eventos adversos informados por el paciente (PRO-CTCAE)
Periodo de tiempo: Hasta 4 años aproximadamente
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Hasta 4 años aproximadamente
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Objective response (OR) per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
Periodo de tiempo: Up to approximately 4 years
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Up to approximately 4 years
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Progression free survival (PFS) per RECIST v1.1
Periodo de tiempo: Up to approximately 4 years
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Up to approximately 4 years
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Duration of response (DOR) per RECIST v1.1
Periodo de tiempo: Up to approximately 4 years
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Up to approximately 4 years
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Disease control (DC) per RECIST v1.1
Periodo de tiempo: Up to approximately 4 years
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Up to approximately 4 years
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Number of participants with treatment-emergent adverse events (TEAEs) and Treatment-related Adverse Events (TRAEs)
Periodo de tiempo: Up to approximately 4 years
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Up to approximately 4 years
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Change from Baseline in Visual Analogue Scale (VAS) score of the EuroQol5 Dimension (EQ-5D-5L)
Periodo de tiempo: Up to approximately 4 years
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Up to approximately 4 years
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Responses to Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire on symptom bother
Periodo de tiempo: Up to approximately 4 years
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Up to approximately 4 years
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Responses to Therapy Administration Satisfaction Questionnaire (TASQ)
Periodo de tiempo: Up to approximately 4 years
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Up to approximately 4 years
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Number of Participants with Anti-tarlatamab Antibody Formation
Periodo de tiempo: Up to approximately 4 years
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Up to approximately 4 years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: MD, Amgen
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
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 (Actual)
28 de agosto de 2026
Finalización primaria (Estimado)
24 de septiembre de 2027
Finalización del estudio (Estimado)
30 de julio de 2030
Fechas de registro del estudio
Enviado por primera vez
12 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de agosto de 2026
Publicado por primera vez (Actual)
21 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
16 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20250046
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Marco de tiempo para compartir IPD
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities.
There is no end date for eligibility to submit a data sharing request for this study.
Criterios de acceso compartido de IPD
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s).
In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling.
Requests are reviewed by a committee of internal advisors.
If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision.
Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement.
This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications.
Further details are available at the URL below.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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