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by Estudio Clínico Chile
Etapa actual del estudio en Chile: Reclutamiento (buscando participantes para el estudio clínico)
DESCRIPCIÓN
Estudio de osimertinib con o sin quimioterapia versus quimioterapia sola como terapia neoadyuvante para pacientes con cáncer de pulmón de células no pequeñas resecable con EGFRm positivo (NeoADAURA)
Tumor Primario: Pulmón
Fase: 3
Ramas de tratamiento:
- A: QUIMIOTERAPIA + OSIMERTINIB
- B: QUIMIOTERAPIA
Criterios de inclusión: EIII resecable candidata a neoady con EGFR+.
Inclusion Criteria:
- Male or female, at least 18 years of age. For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative
- Histologically or cytologically documented non-squamous NSCLC with completely resectable (Stage II – IIIB N2) disease (according to Version 8 of the IASLC Cancer Staging Manual [IASLC Staging Manual in Thoracic Oncology 2016]).
- Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialised in oncologic procedures).
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 at enrolment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing
- A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (ie, T790M, G719X, Exon20 insertions, S7681 and L861Q).
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