Resumen del Estudio
Este estudio clínico de Fase 3 tiene como objetivo principal mejorar las expectativas de vida en pacientes diagnosticados con Cáncer de Pulmón de Células Pequeñas en Estadio Extendido (CPCP-EE) que no han recibido tratamiento previo. La investigación busca determinar si intensificar la terapia estándar ofrece mejores resultados. Actualmente, el tratamiento habitual combina inmunoterapia (Durvalumab) con quimioterapia (Carboplatino y Etopósido). Este ensayo comparará si añadir un nuevo fármaco llamado Tarlatamab a esta combinación logra prolongar la supervivencia global de los pacientes de manera significativa frente al tratamiento estándar actual.
Criterios de Elegibilidad
Resumen de Elegibilidad:El estudio busca adultos (18+) con diagnóstico confirmado de CPCP en estadio extendido aptos para recibir quimio-inmunoterapia. Se excluyen pacientes con metástasis cerebrales sintomáticas, enfermedades autoinmunes activas, eventos cardiovasculares graves recientes o infecciones activas por Hepatitis B, C o VIH.
- 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.
- 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.