RecruitingPhase 1Phase 2NCT04270591

Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer

A Phase Ib/II, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Glumetinib (SCC244), a Selective MET Inhibitor in Patients With Advanced Non-Small Cell Lung Cancer Harboring MET-alterations

Sponsor

Haihe Biopharma Co., Ltd.

Enrollment

183 participants

Start Date

Jul 15, 2019

Study Type

INTERVENTIONAL

Conditions

C-Met Exon 14 Mutation

Summary

Indication:Patients with Advanced c-MET-positive Non-Small Cell Lung Cancer Phase Ib (China only): Approximately 90 patients Phase Ⅱ (globally): Approximately 78 evaluable patients; addition of at least 6 patients in Safety Run-in (US only)

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called glumetinib (a MET inhibitor) in patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic change called MET exon 14 skipping mutation or MET amplification, to find the best dose and evaluate how well it works. **You may be eligible if:** - You are 18 or older with confirmed advanced or metastatic non-small cell lung cancer - Your tumor has a MET exon 14 skipping mutation or MET amplification, confirmed by lab testing - You have stage IIIB, IIIC, or IV lung cancer that cannot be cured with surgery or radiation - You have received prior systemic treatments as specified for your particular cancer subtype **You may NOT be eligible if:** - Your tumor does not have a qualifying MET gene alteration - You have significant organ dysfunction (heart, liver, kidneys) - You are pregnant or not using appropriate contraception - You have uncontrolled brain metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGlumetinib

The investigational product will be orally administrated when fasting at dose level of 300mg QD

Locations(44)

Norton Cancer Institute

Louisville, Kentucky, United States

The Oncology Institute of Hope & Innovation

Louisville, Kentucky, United States

Anhui Province Hospital

Hefei, Anhui, China

The Chest Hospital of Anhui Province

Hefei, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Cancer Hospita

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Union Medical College Hospital Affiliated to Fujian Medical University

Fuzhou, Fujian, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Cancer Hospital Affiliated to Guangxi Medical University

Nanning, Guangxi, China

Hainan Cancer Hospital

Haikou, Hainan, China

Cancer Hospital Affiliated to Harbin Medical University

Harbin, Heilongjiang, China

Henan Province Cancer Hospital

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Wuhan Union Hospital

Wuhan, Hubei, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Jiangsu Province People's Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

First Hospital of Jilin University

Changchun, Jilin, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Affiliated Hospital of Hebei University

Baoding, Shandong, China

Shandong University Qilu Hospital

Jinan, Shandong, China

Changhai Hospital

Shanghai, Shanghai Municipality, China

Fudan university Shanghai cancer center

Shanghai, Shanghai Municipality, China

The Chest Hospital of Shanghai

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital，College of of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Zhejiang Province Cancer Hospital

Hangzhou, Zhejiang, China

Hunan Province Cancer Hospital

Changsha, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Ehime University Hospital

Ehime, Japan

Kyushu University Hospital

Fukuoka, Japan

Kanagawa Cancer Center

Kanagawa, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Kindai University Hospital

Osaka, Japan

Osaka International Cancer Institute

Osaka, Japan

Hokkaido University Hospital

Sapporo, Japan

Shizuoka Cancer Center

Shizuoka, Japan

National Cancer Center Hospital East

Tokyo, Japan

National Cancer center

Tokyo, Japan

Tottori University Hospital

Tottori, Japan

View Full Details on ClinicalTrials.gov

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NCT04270591