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The primary objective of this study is to characterize the safety profile of sotorasib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chinese Participants Treated with 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 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotorasib | Drug | Participants will have received sotorasib orally daily until disease progression or unacceptable toxicity. |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) from Initial Date of Sotorasib Use to Date of Death | Up to approximately 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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The target population is adult participants with KRAS p.G12C-mutated locally advanced or metastatic NSCLC and previously treated with at least 1 prior systemic therapy that have received sotorasib treatment in BOAO Pilot Zone.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boao Evergrande International Hospital | Qionghai | Hainan | 571400 | China | ||
| Boao Super Hospital |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000706028 | sotorasib |
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| Qionghai |
| Hainan |
| 571499 |
| China |
| Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine Hainan Boao Research Hospital | Qionghai | Hainan | 57400 | China |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |