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by Estudio Clínico Chile
Etapa actual del estudio en Chile: Reclutamiento (buscando participantes para el estudio clínico)
DESCRIPCIÓN
La hipótesis primaria es que la co-formulación PEMBROLIZUMAB/VIBOSTOLIMAB es superior a PEMBROLIZUMAB respecto a sobrevida libre de progresión y sobrevida global en pacientes con cáncer pulmonar no células pequeñas PDL1+.
Tumor Primario: Pulmón
Fase: 3
Ramas de Tratamiento:
- A: PEMBROLIZUMAB / VIBOSTOLIMAB (MK-7684A)
- B: PEMBROLIZUMAB
Criterios de inclusión: CPNCP EIV PDL1+
- Has a histologically or cytologically confirmed diagnosis of Stage IV: M1a, M1b, or M1c non-small cell lung cancer (NSCLC) per the American Joint Committee on Cancer (AJCC) Staging Manual, version 8
- Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the local site assessment
- Has confirmation that epidermal growth factor receptor (EGFR)-, anaplastic lymphoma kinase (ALK)-, or reactive oxygen species proto-oncogene 1 (ROS1)-directed therapy is not indicated as primary therapy and absence of ALK and ROS1 gene rearrangements
- Has provided tumor tissue that demonstrates Programmed Cell Death 1 Ligand 1 (PD-L1) expression in ≥1% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
- Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 assessed within 7 days prior to randomization
- Has a life expectancy of at least 3 months
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A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP)
- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days after the last dose of study intervention
- Has adequate organ function
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