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

DESCRIPCIÓN

El propósito de este estudio es medir la seguridad y eficacia de pembrolizumab combinado con radioquimioterapia concurrente, seguido de: pembrolizumab (rama 1) o pemrolizumab y olaparib (rama 2), comparado a radioquimioterapia seguido de durvalumab (rama 3), en pacientes con cáncer pulmonar no células pequeñas localmente avanzado e irresecable. Las ramas 1 y 2 serán estudiadas con diseño doble ciego y la rama 3 con etiqueta abierta.

Las hipótesis primarias son

  1. Pembrolizumab con radioquimioterapia concurrente seguida de pembrolizumab y olaparib (rama2) es superior a RtQt seguido de druvalumab (rama 3) respecto a sobrevida libre de progresión y sobrevida global.
  2. Pembrolizumab con radioquimioterapia concurrente seguida de pembrolizumab (rama 1) es superior a RtQt seguido de druvalumab (rama 3) respecto a sobrevida libre de progresión y sobrevida global.

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Tumor Primario: Pulmón

Fase: 3

Rama única de tratamiento: 

  • A) Radioquimioterapia junto a pembrolizumab, seguido de pembrolizumab y olaparib.
  • B) Radioquimioterapia junto a pembrolizumab, seguido de pembrolizumab.
  • C) Radioquimioterapia, seguido de durvalumab.

Criterios de inclusión: Cáncer pulmonar no células pequeñas etapa III no resecable, candidato a RtQt definitiva, sin terapia previa.

Inclusion Criteria:

  • Has histologically or cytologically confirmed melanoma
  • Has unresectable Stage III or Stage IV melanoma, as per American Joint Committee on Cancer guidelines, not amenable to local therapy
  • Has been untreated for advanced or metastatic disease except as follows: a. proto-oncogene B-Raf (BRAF) V600 mutation-positive melanoma may have received standard of care targeted therapy as first-line therapy for advanced or metastatic disease. b. Prior adjuvant or neoadjuvant therapy, with targeted therapy or immunotherapy (such as anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], anti-programmed cell death 1 [anti-PD-1] therapy or Interferon) will only be permitted if relapse did not occur during active treatment or within 6 months of treatment discontinuation.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
  • Has the presence of ≥1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1
  • Provides a tumor biopsy. Participants must submit tumor sample during Screening for confirmation of adequacy of tumor tissue at a central pathology laboratory. Participants who do not submit a tumor tissue sample will not be randomized. The tumor biopsy may not be obtained from a lone target lesion. Confirmation of presence of tumor tissue is not required prior to randomization.
  • Has resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia). If participant received major surgery or radiation therapy of >30 Gray (Gy), they must have recovered from the toxicity and/or complications from the intervention.
  • Male participants must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period
  • Female participants must not be pregnant, not breastfeeding, and ≥1 of the following conditions applies: a. Not a woman of childbearing potential (WOCBP) OR b. A WOCBP who agrees to use study-approved contraception during the treatment period and for at least 120 days after the last dose of study treatment
  • Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mmHg at screening and no change in antihypertensive medications within 1 week before Cycle 1 Day 1
  • Has adequate organ function

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: Bradford Hill

Investigador Principal: Dr. Carlos Rojas

Centro de Investigación: CION Antofagasta

Investigador Principal: Dr. Henry Barrios