Clinical trial · Observational
Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients
NCT07143513CI-TRIAL-00107503completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to characterize the safety profile of sotorasib.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sotorasib | Drug | Sotorasib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Chinese Participants Treated with Sotorasib
- description
- 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 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.
- interventionNames
- Drug: Sotorasib
Primary outcomes (8)
- measure
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)
- timeFrame
- Up to approximately 4 years
- measure
- Number of Participants with Adverse Events of Interest, Inclusive of Hepatotoxicity, Interstitial Lung Disease/Pneumonitis, and Renal Toxicity
- timeFrame
- Up to approximately 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.