Non-Small Cell Lung Cancer
Conditions
Keywords
Non-Small Cell Lung Cancer, Sotorasib, AMG 510
Brief summary
The primary objective of this study is to characterize the safety profile of sotorasib.
Interventions
DRUGSotorasib
Participants will have received sotorasib orally daily until disease progression or unacceptable toxicity.
Sponsors
Amgen
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (≥ 18 years) as of the index date. * KRAS p.G12C-mutated locally advanced or metastatic NSCLC. * Received at least 1 dose of sotorasib. * Receipt of at least 1 prior systemic therapy before use of sotorasib. * Obtained ICF, if required.
Exclusion criteria
* Documentation of being a non-Chinese ethnicity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Up to approximately 4 years |
| Number of Participants with Adverse Events of Interest, Inclusive of Hepatotoxicity, Interstitial Lung Disease/Pneumonitis, and Renal Toxicity | Up to approximately 4 years |
| Number of Participants with Treatment-related Adverse Events (AEs) | Up to approximately 4 years |
| Number of Participants with Treatment-related AEs of Grade 3 or Worse | Up to approximately 4 years |
| Number of Participants with Serious Treatment-related AEs | Up to approximately 4 years |
| Number of Participants with Treatment-related AEs Leading to Treatment Discontinuation | Up to approximately 4 years |
| Number of Participants with Treatment-related AEs Leading to Dose Reduction | Up to approximately 4 years |
| Number of Participants with Treatment-related AEs Leading to Death | Up to approximately 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) from Initial Date of Sotorasib Use to Date of Death | Up to approximately 4 years |
Countries
China
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed