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Expanded Access of Sotorasib
Expanded Access of Sotorasib

NCT04667234

No Longer AvailableN/A

Sponsor: Amgen

Conditions: Non Small-cell Lung Cancer, Locally Advanced Unresectable NSCLC, Locally Advanced Metastatic NSCLC

Interventions: AMG 510

Countries: United States, Argentina, Brazil, Israel, Saudi Arabia, Taiwan

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 overview

Sex: ALL

Age: 18 Years to 99 Years

Study type: EXPANDED_ACCESS

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
Locations (55)
  • Huntsville, Alabama, United States
  • Anchorage, Alaska, United States
  • Chandler, Arizona, United States
  • Tucson, Arizona, United States
  • Alamosa, Colorado, United States
  • Lone Tree, Colorado, United States
  • Pensacola, Florida, United States
  • Decatur, Illinois, United States
  • Ames, Iowa, United States
  • Des Moines, Iowa, United States
  • Lexington, Kentucky, United States
  • Baton Rouge, Louisiana, United States
  • Brewer, Maine, United States
  • Cumberland, Maryland, United States
  • Rockville, Maryland, United States
  • Boston, Massachusetts, United States
  • Midland, Michigan, United States
  • Kansas City, Missouri, United States
  • Springfield, Missouri, United States
  • Omaha, Nebraska, United States
  • Englewood, New Jersey, United States
  • Summit, New Jersey, United States
  • Winston-Salem, North Carolina, United States
  • Cleveland, Ohio, United States
  • Allentown, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Scranton, Pennsylvania, United States
  • Chattanooga, Tennessee, United States
  • Memphis, Tennessee, United States
  • Huntington, West Virginia, United States
  • + 25 more on CT.gov