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Etapa actual del estudio en Chile: Reclutamiento (buscando participantes para el estudio clínico)

DESCRIPCIÓN

El objetico de este estudio es determinar actividad tumoral, farmacocinética y sobrevida libre de progresión de SAR408701 en combinación con pembrolizumab y de pembrolizumab monoterapia en pacientes con cáncer pulmonar no células pequeñas, no escamoso con CECAM5+.

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Tumor Primario: Pulmón

Fase: 2

Ramas de tratamiento:

  • A: SAR408701 + PEMBROLIZUMAB
  • B: PEMBROLIZUMAB

Criterios de inclusión: NCP IV o avanzado CECAM5 +

Inclusion criteria :

  • Histologically- or cytologically-confirmed diagnosis of advanced or metastatic NSQ NSCLC with no EGFR sensitizing mutation or BRAF mutation or ALK/ROS alterations.
  • No prior systemic chemotherapy for the treatment of the participant’s advanced or metastatic disease (treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as completed at least 6 months prior to diagnosis of advanced or metastatic disease).
  • Expression of CEACAM5 as demonstrated prospectively by a centrally assessed Immunohistochemistry (IHC) assay of ≥2+ in intensity involving at least 50% of the tumor cell population in archival tumor sample (or if not available fresh biopsy sample).
  • PD-L1 positive tumor (TPS ≥1%) as determined locally by an approved test
  • Measurable disease based on RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
  • Capable of giving signed informed consent

CENTROS DE INVESTIGACIÓN

Este es un estudio multicéntrico a nivel global y se desarrolla en los siguientes centros de investigación de Chile:

Centro de Investigación: Prosalud

Investigador Principal: Dr. Francisco Orlandi

Centro de Investigación: Bradford Hill

Investigador Principal: Dr. Carlos Rojas