Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients

NCT07143513 | Recruiting FDA Drug

• 1 other identifier: 20240175
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objective of this study is to characterize the safety profile of sotorasib.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Sotorasib; AMG 510

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Overall Survival (OS) from Initial Date of Sotorasib Use to Date of Death

  Up to approximately 4 years

Study Arms (1)

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 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.

Drug: Sotorasib

Interventions

Sotorasib DRUG

Participants will have received sotorasib orally daily until disease progression or unacceptable toxicity.

Also known as: AMG 510

Chinese Participants Treated with Sotorasib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 either location of BOAO Pilot Zone and Hong Kong SAR.

You may qualify if:

• 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.

You may not qualify if:

• Documentation of being a non-Chinese ethnicity.

Sponsors & Collaborators

• Amgen: lead

Study Sites (3)

Boao Evergrande International Hospital

Qionghai, Hainan, 571400, China

RECRUITING

Boao Super Hospital

Qionghai, Hainan, 571499, China

RECRUITING

Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine Hainan Boao Research Hospital

Qionghai, Hainan, 57400, China

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sotorasib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: August 11, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 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.
• Access Criteria: 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.

Locations

CN (3)