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

NCT ID: NCT07143513

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-11

Study Completion Date

2026-06-30

Brief Summary

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

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Sotorasib

Intervention Type DRUG

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

Interventions

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Sotorasib

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

Intervention Type DRUG

Other Intervention Names

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AMG 510

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Boao Evergrande International Hospital

Qionghai, Hainan, China

Site Status RECRUITING

Boao Super Hospital

Qionghai, Hainan, China

Site Status RECRUITING

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

Qionghai, Hainan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Amgen Call Center

Role: CONTACT

866-572-6436

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20240175

Identifier Type: -

Identifier Source: org_study_id

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