Study Complete
Sponsor ID
20240175
Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients
Study Details
The primary objective of this study is to characterize the safety profile of sotorasib.
Protocol Summary
Primary Outcome Measures
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to approximately 4 years
Number of Participants with Adverse Events of Interest, Inclusive of Hepatotoxicity, Interstitial Lung Disease/Pneumonitis, and Renal Toxicity
Timeframe: Up to approximately 4 years
Number of Participants with Treatment-related Adverse Events (AEs)
Timeframe: Up to approximately 4 years
Number of Participants with Treatment-related AEs of Grade 3 or Worse
Timeframe: Up to approximately 4 years
Number of Participants with Serious Treatment-related AEs
Timeframe: Up to approximately 4 years
Number of Participants with Treatment-related AEs Leading to Treatment Discontinuation
Timeframe: Up to approximately 4 years
Number of Participants with Treatment-related AEs Leading to Dose Reduction
Timeframe: Up to approximately 4 years
Number of Participants with Treatment-related AEs Leading to Death
Timeframe: Up to approximately 4 years
Secondary Outcome Measures
Overall Survival (OS) from Initial Date of Sotorasib Use to Date of Death
Timeframe: Up to approximately 4 years
Locations
Location
Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine Hainan Boao Research Hospital
Qionghai, Hainan, China, 57400
Status
Recruiting
Location
Boao Evergrande International Hospital
Qionghai, Hainan, China, 571400
Status
Recruiting
Location
Boao Super Hospital
Qionghai, Hainan, China, 571499
Status
Recruiting