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OpenTrials
Completed

NCT Number: NCT07143513

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

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

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boao Evergrande International Hospital, Qionghai, Hainan, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sotorasib

Drug

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

Other names: AMG 510

Primary outcomes

  1. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 4 years

  2. Number of Participants with Adverse Events of Interest, Inclusive of Hepatotoxicity, Interstitial Lung Disease/Pneumonitis, and Renal Toxicity

    Time frame: Up to approximately 4 years

  3. Number of Participants with Treatment-related Adverse Events (AEs)

    Time frame: Up to approximately 4 years

  4. Number of Participants with Treatment-related AEs of Grade 3 or Worse

    Time frame: Up to approximately 4 years

  5. Number of Participants with Serious Treatment-related AEs

    Time frame: Up to approximately 4 years

  6. Number of Participants with Treatment-related AEs Leading to Treatment Discontinuation

    Time frame: Up to approximately 4 years

  7. Number of Participants with Treatment-related AEs Leading to Dose Reduction

    Time frame: Up to approximately 4 years

  8. Number of Participants with Treatment-related AEs Leading to Death

    Time frame: Up to approximately 4 years

Secondary outcomes

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

    Time frame: Up to approximately 4 years

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2025
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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