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

Sponsor
Amgen
Study ID
NCT07143513
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sotorasib — DRUG
    Participants will have received sotorasib orally daily until disease progression or unacceptable toxicity.

Study Details

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

Key Dates

Start date
Aug 11, 2025
Status verified
Mar 2026
Primary completion
Dec 7, 2025
Completion
Dec 7, 2025

Study Design

Enrollment
102 participants (actual)

Arms

  • Arm: 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.

Primary Outcome Measure

Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 4 years ]

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