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Clinical Trials List

Protocol Number20190436
NCT Number(ClinicalTrials.gov Identfier)NCT04667234

2021-05-31 - 2024-12-31

Phase III

Not yet recruiting1

Recruiting6

A Multicenter, Open-label, Single-arm, Expanded Access Protocol of AMG 510 (Sotorasib) for the Treatment of Subjects with Previously Treated Locally Advanced Unresectable/Metastatic NSCLC with KRAS p.G12C Mutation

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    Amgen Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator JIN-YUAN SHIH Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張晃智 Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Gee-chen Chang Division of Hematology & Oncology
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ping-Chih Hsu Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Hung Luo Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Non Small-cell Lung Cancer

Objectives

The primary objective of this study is to provide expanded access to and characterize the safety profile of Sotorasib in participants with previously treated locally advanced/unresectable/metastatic non small-cell lung cancer (NSCLC) with KRAS p.G12C mutation in a real-world setting.

Test Drug

AMG 510 (Sotorasib)

Active Ingredient

AMG 510

Dosage Form

tablet

Dosage

120

Endpoints

目標：
● 在臨床實務中提供擴大供藥，以及探討 sotorasib 用於先前接受過治療、局部晚期/無法手術切除/轉移且
帶有 KRAS p.G12C 突變之非小細胞肺癌 (NSCLC) 受試者的安全性
● 說明並收集 KRAS p.G12C 突變陽性 NSCLC 受試者的檢驗結果
● 使用整體存活期評估 sotorasib 的療效
● 評估 sotorasib 的治療期間

評估指標：
● 治療中出現不良事件 (TEAE)、關注之不良事件、治療相關不良事件、嚴重 TEAE、導致停用 sotorasib 之 TEAE 的發生率
● KRAS p.G12C 檢驗結果
● 整體存活期
● 治療期間

Inclution Criteria

Inclusion Criteria

Age ≥ 18 years
Ineligibility for participation in any Amgen-sponsored ongoing clinical study of the investigational product
Pathologically documented, locally-advanced and unresectable or metastatic Non Small-Cell Lung Cancer (NSCLC) with KRAS p.G12C mutation confirmed through molecular testing
Exhausted other standard of care options for locally advanced and unresectable or metastatic NSCLC disease including platinum-based combination chemotherapy and programmed cell death protein 1/programmed death-ligand 1 (PD 1/PD-L1) immunotherapy (unless medically contraindicated)
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

Exclusion Criteria

Exclusion Criteria

Mixed small-cell lung cancer or mixed NSCLC histology
Active brain metastases
Active hepatitis B or hepatitis C virus
Current active malignancy other than NSCLC
Currently or previously enrolled in a prior sotorasib study unless radiographic disease progression confirmed, able to remain on long term follow up of their original protocol and receives medical monitor approval
Female participants planning to become pregnant while on study through 7 days after the last dose of sotorasib

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    350 participants

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