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No Longer Available
NCT04667234
Expanded Access of Sotorasib
Conditions: Non Small-cell Lung Cancer, Locally Advanced Unresectable NSCLC, Locally Advanced Metastatic NSCLC
Sex: All
Ages: 18 Years – 99 Years
Sponsor: Amgen
Location: Clearview Cancer Institute Huntsville Alabama
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT04667234). StuddyBuddy aggregates publicly available trial information.