Status:
NO_LONGER_AVAILABLE
Expanded Access of Sotorasib
Lead Sponsor:
Amgen
Conditions:
Non Small-cell Lung Cancer
Locally Advanced Unresectable NSCLC
Eligibility:
All Genders
18-99 years
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 n...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04667234
Last Update
August 13 2025
Active Locations (55)
Enter a location and click search to find clinical trials sorted by distance.
1
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
2
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States, 99508
3
Ironwood Cancer and Research Center
Chandler, Arizona, United States, 85224
4
Arizona Oncology Associates Professional Corporation
Tucson, Arizona, United States, 85711