Spots Global Cancer Trial Database for Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer
Official Title: 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
Study ID: NCT04270591
Conditions
Interventions
Study Description
Brief 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)
Detailed Description: Phase Ib study population Approximately 90 patients with locally advanced or metastatic NSCLC (Stage IIIb, IIIc or IV) including pulmonary sarcomatoid carcinoma (PSC). All patients should carry at least one of the following MET alterations (confirmed by local or central laboratory): * Patients with METex14 skipping mutation who had previously treated by other MET inhibitor(s) * Patients with METex14 skipping mutation who had received 3 or more lines prior systemic therapies without MET inhibitor for the advanced NSCLC * Patients with MET amplification (GCN ≥ 4 or MET/CEP7 ratio ≥ 2) * Patients with MET over-expression (IHC2+) Phase II - Safety Run-in Population (US only) A minimum of 6 patients who meeting the eligibility for either Phase Ib or Phase II. Phase II study population (globally) Approximately 78 evaluable patients with locally advanced or metastatic NSCLC (Stage IIIb, IIIc or IV, including PSC) harboring METex14 skipping mutation that have been pre-screened by local or Sponsor-designated central laboratory, who are not eligible for chemotherapy or refuse of chemotherapy after well-informed or have failed one or two prior lines of systemic therapies and have not had prior MET inhibitor for the advanced NSCLC.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, China
Beijing Cancer Hospita, Beijing, Beijing, China
Peking Union Medical College Hospital, Beijing, Beijing, 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, Ha'erbin, 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, China
Fudan university Shanghai cancer center, Shanghai, Shanghai, China
The Chest Hospital of Shanghai, Shanghai, Shanghai, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Tianjin Cancer Hospital, Tianjin, Tianjin, China
Tianjin Medical University General Hospital, Tianjin, Tianjin, 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
Contact Details
Name: James Zhou, MD
Affiliation: Haihe Biopharma
Role: STUDY_DIRECTOR
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