Official Title
A Multicenter, Open-label, Single-arm, Expanded Access Protocol of AMG 510 (pINN Sotorasib) for the Treatment of Subjects With Previously Treated Locally Advanced Unresectable/Metastatic NSCLC With KRAS p.G12C Mutation
Brief Summary

The primary objective of this study is to provide expanded access to and characterize the safety profile of AMG 510 (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.

Available
Treatment IND/Protocol
Non Small-cell Lung Cancer
Locally Advanced Unresectable NSCLC
Locally Advanced Metastatic NSCLC

Drug: AMG 510
Administered as an oral tablet.
Other Name: Sotorasib

Eligibility Criteria

Inclusion Criteria - Age ≥ 18 years - Ineligibility for participation in any 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 disease including platinum-based combination chemotherapy and PD 1/PD-L1 immunotherapy (unless contraindicated) - Performance Status ≤ 2

Exclusion Criteria - Active Brain Metastases - Active hepatitis B or hepatitis C virus - Current active malignancy other than NSCLC - Participants previously enrolled in sotorasib Study 20190009 (CodeBreaK 200)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years~Maximum: 99 Years
Contacts

Amgen Call Center
866-572-6436
medinfo@amgen.com

MD
Study Director
Amgen

NCT Number
Keywords
NSCLC
KRAS p.G12C Mutation
MeSH Terms
Carcinoma, Non-Small-Cell Lung
Intervention Name
AMG 510