Locally Advanced Metastatic NSCLC, Locally Advanced Unresectable NSCLC, Non Small-cell Lung Cancer
Conditions
Keywords
NSCLC, KRAS p.G12C Mutation
Brief summary
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.
Interventions
DRUGAMG 510
Administered as an oral tablet.
Sponsors
Amgen
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Inclusion criteria
* 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
Exclusion criteria
* 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
Countries
Argentina, Brazil, Israel, Saudi Arabia, Taiwan, United States
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed