Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients
- Registration Number
- NCT07143513
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective of this study is to characterize the safety profile of sotorasib.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 115
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Chinese Participants Treated with Sotorasib Sotorasib Adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) and previously treated with at least 1 prior systemic therapy that have received sotorasib treatment in either location of BOAO Pilot Zone and Hong Kong SAR will be included in this cohort. The duration of evidence collection is from initiation of sotorasib to the end of study period, up to approximately 4 years from the date of the first available sotorasib use in BOAO Pilot Zone of around August 2021.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Overall Survival (OS) from Initial Date of Sotorasib Use to Date of Death Up to approximately 4 years