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Ícono de BMS, estudio Activo, no reclutando

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ID del estudio CA239-0013  |   NCT04685135

Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

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Lo sentimos, este estudio ya no acepta nuevos participantes, pero aún está en curso.
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Resumen

  • Phase 3
  • Ícono de género masculino y femenino
  • 18+
  • Ícono de BMS, estudio Activo, no reclutando
    Active, Not Recruiting

Descripción general

This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.

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Criterios clave de elegibilidad

Criterios de inclusión

Criterios de inclusión Icon
:
  • Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.
    1. Candidacy to receive treatment with docetaxel. Crossover Inclusion Criteria:
      1. Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR
        1. ECOG performance status 0-2

          Criterios de exclusión

          Criterios de exclusión Icon
          :
          • Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib).
            1. Active brain metastases. Crossover Exclusion Criteria:
              1. Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.
                Información Adicional *

                Opciones de tratamiento

                Brazos del estudio

                INTERVENCIÓN ASIGNADA

                Brazos del estudio

                Active Comparator: Docetaxel

                INTERVENCIÓN ASIGNADA
                • Drug: Docetaxel

                Brazos del estudio

                Experimental: MRTX849

                INTERVENCIÓN ASIGNADA
                • Drug: MRTX849

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