Estudio fase 3, abierto, multicéntrico y aleatorizado de tarlatamab en primera línea en combinación con durvalumab, carboplatino y etopósido versus durvalumab, carboplatino y etopósido en cáncer de pulmón de células pequeñas en estadio extenso no tratado previamente (DeLLphi-312)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT07005128Tipo: INTERVENTIONALInicio: 18 de ago de 2025Fin estimado: 15 de jul de 2029

Resumen

El objetivo principal del estudio es comparar la eficacia de tarlatamab en combinación con durvalumab, carboplatino y etopósido respecto a la combinación de durvalumab, carboplatino y etopósido en la prolongación de la supervivencia global (SG).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 99 YearsSexo: ALL

Criterios de inclusión

Participant has provided informed consent before initiation of any study-specific activities/procedures.
Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years.
Histologically or cytologically documented ES-SCLC (American Joint Committee on Cancer, 2017, Stage IV SCLC \[T any, N any, M1 a/b/c\]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.
Measurable disease as defined per RECIST 1.1.
Suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment.
Minimum life expectancy ≥ 12 weeks.

Criterios de exclusión

Participants can have no history of other malignancy in the last 2 years.
Any symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.
They will have no history of severe or life-threatening events to immune-mediated therapy.
History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
They will have no active autoimmune or inflammatory disorders.
Presence of active human immunodeficiency virus (HIV) or active Hepatitis (B/C) infection.
Evidence or interstitial lung disease (ILD) or active, non-infectious pneumonitis.
History of solid organ transplant.
They will not have had a myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 6 months prior to first dose of study treatment.

Intervenciones

drug

Tarlatamab

Tarlatamab will be administered as an intravenous (IV) infusion.

drug

Durvalumab

Durvalumab will be administered as an IV infusion.

drug

Carboplatin

Carboplatin will be administered as an IV infusion.

drug

Etoposide

Etoposide will be administered as an IV infusion.

Ubicaciones

Cemic

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

RECRUITING

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

RECRUITING

Sanatorio Parque SA

Rosario, Santa Fe Province, Argentina

RECRUITING

Patrocinadores

PrincipalAmgen

ColaboradorAstraZeneca

Contactos

Amgen Call Center

CONTACT

medinfo@amgen.com 866-572-6436

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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