A Multicenter, Open-label, Single-arm, Expanded Access Protocol of Sotorasib for the Treatment of Subjects With Previously Treated Locally Advanced Unresectable/Metastatic NSCLC With KRAS p.G12C Mutation

DesconocidoClinicalTrials.gov

ID: NCT04667234Tipo: EXPANDED_ACCESS

Traducción no disponible, mostrando original

Resumen

The primary objective of this study is to provide expanded access to and characterize the safety profile of Sotorasib in participants with previously treated locally advanced/unresectable/metastatic non small-cell lung cancer (NSCLC) with KRAS p.G12C mutation in a real-world setting.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 99 YearsSexo: ALL

Criterios de inclusión

Age ≥ 18 years
Ineligibility for participation in any Amgen-sponsored ongoing clinical study of the investigational product
Pathologically documented, locally-advanced and unresectable or metastatic Non Small-Cell Lung Cancer (NSCLC) with KRAS p.G12C mutation confirmed through molecular testing
Exhausted other standard of care options for locally advanced and unresectable or metastatic NSCLC disease including platinum-based combination chemotherapy and programmed cell death protein 1/programmed death-ligand 1 (PD 1/PD-L1) immunotherapy (unless medically contraindicated)
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

Criterios de exclusión

Mixed small-cell lung cancer or mixed NSCLC histology
Active brain metastases
Active hepatitis B or hepatitis C virus
Current active malignancy other than NSCLC
Currently or previously enrolled in a prior sotorasib study unless radiographic disease progression confirmed, able to remain on long term follow up of their original protocol and receives medical monitor approval
Female participants planning to become pregnant while on study through 7 days after the last dose of sotorasib

Intervenciones

drug

AMG 510

Administered as an oral tablet.

Ubicaciones

Instituto Médico Especializado Alexander Fleming

Capital Federal, Buenos Aires, Argentina

Hospital Aleman

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Cemic

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Clínica Universitaria Privada Reina Fabiola

Córdoba, Argentina

Patrocinadores

PrincipalAmgen

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