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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.
Condition or disease
Non Small-cell Lung CancerLocally Advanced Unresectable NSCLCLocally Advanced Metastatic NSCLC
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
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 99 Years (Adult, Older Adult)
Sexes Eligible for Study:
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
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