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Sponsor ID
20190436

Expanded Access of Sotorasib

Sponsor ID
20190436
Clinicaltrials.gov ID
NCT04667234
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
AMG 510
Type
Expanded Access
Masking
N/A
Enrollment
N/A
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

Locations

Location
Status
Contact Us
Location
Clearview Cancer Institute
Huntsville, AL, United States, 35805
Status
Recruiting
Location
Saint Joseph East
Lexington, KY, United States, 40509
Status
Recruiting
Location
Sacred Heart Medical Oncology Group
Pensacola, FL, United States, 32504
Status
Recruiting
Location
Scranton Hematology Oncology
Scranton, PA, United States, 18510
Status
Recruiting
Location
Saint Lukes Cancer Institute
Kansas City, MO, United States, 64111
Status
Terminated
Location
Nebraska Cancer Specialists
Omaha, NE, United States, 68130
Status
Recruiting
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Study Info
Age
18 - 99 Years
Condition
  • Lung Cancer - Non-Small Cell
    • Show more
  • Lung Cancer - General
    • Sex
    All
    Trial Dates
    N/A - N/A
    Inclusion and Exclusion 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