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Ícono de BMS, studio Reclutando

Recruiting

ID del estudio CA239-0012  |   NCT05853575

Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)

Resumen

  • Phase 2
  • Ícono de género masculino y femenino
  • 18+
  • 37
  • Ícono de BMS, studio Reclutando
    Recruiting

Descripción general

This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.

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Criterios clave de elegibilidad

Key

Criterios de inclusión

Criterios de inclusión Icon
:
  • Are at least 18 years old (or old enough to legally make their own treatment decisions, according to local laws).
    1. Have advanced NSCLC or metastatic NSCLC (NSCLC that started in the lungs and then spread to other parts of the body) with the KRAS G12C mutation.
      1. Have had previous treatment with 1) chemotherapy that included a drug called cisplatin or a drug called carboplatin and 2) a type of drug called an immune checkpoint inhibitor.
        1. Have recovered from their prior treatment and blood tests are within a safe range. Key

          Criterios de exclusión

          Criterios de exclusión Icon
          :
          • Have had previous treatment with a drug that targets KRAS G12C.
            1. Have cancer that can potentially be removed with surgery.
              1. Patients with brain lesions are not eligible if 1) any untreated brain lesions are > 2.0 cm in size 2) any brainstem lesions are present 3) ongoing steroid dosing >10 mg daily prednisone (or equivalent) and 4) poorly controlled (> 1/week) generalized or complex partial seizures or neurologic progression/instability due to brain lesions.
                1. Have certain medical conditions or need to take certain medications that, in the opinion of a trial doctor, could make it unsafe for them to participate or difficult to complete the trial assessments, or are pregnant.
                  Información Adicional *

                  Opciones de tratamiento

                  Brazos del estudio

                  INTERVENCIÓN ASIGNADA

                  Brazos del estudio

                  Experimental: Adagrasib 400mg BID

                  INTERVENCIÓN ASIGNADA
                  • Drug: Adagrasib

                  Brazos del estudio

                  Experimental: Adagrasib 600mg BID

                  INTERVENCIÓN ASIGNADA
                  • Drug: Adagrasib
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