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The primary objective of this study is to provide expanded access to and characterize the safety profile of AMG 510 (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 AMG 510 (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 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 disease including platinum-based combination chemotherapy and programmed cell death protein 1/programmed death-ligand 1 (PD 1/PD-L1) immunotherapy (unless contraindicated)
Performance Status ≤ 2
Active brain metastases
Active hepatitis B or hepatitis C virus
Current active malignancy other than NSCLC
Participants previously enrolled in sotorasib Study 20190009 (CodeBreaK 200)
Female participants planning to become pregnant while on study through 7 days after the last dose of sotorasib