Actively Recruiting
Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer
Led by Haihe Biopharma Co., Ltd. · Updated on 2022-08-01
183
Participants Needed
44
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent voluntarily
- Male and female patients aged 18 years or older
- Histologically or cytologically confirmed diagnosis of NSCLC including pulmonary sarcomatoid carcinoma
- Patients with stage IIIb, IIIc NSCLC ineligible for surgery or concurrent chemoradiation, or stage IV NSCLC
- For Phase Ib: Patients with METex14 skipping mutation previously treated with MET inhibitors, or METex14 skipping mutation with 3 or more prior systemic therapies without MET inhibitors, or MET amplification (GCN 64 4 or MET/CEP7 ratio 64 2), or MET over-expression (IHC2+)
- For Phase II: Patients with METex14 skipping mutation confirmed by local or central lab, not eligible for or refusing chemotherapy, or who failed one or two prior systemic therapies without prior MET inhibitor
- Availability of tumor tissue sample for testing
- At least one measurable lesion per RECIST 1.1 (Phase II)
- ECOG Performance Status of 0-1
- Adequate bone marrow, renal, and liver function as specified
- INR < 1.3 (or < 3.0 if on anticoagulation)
You will not qualify if you...
- Presence of targetable EGFR mutation, ALK rearrangement, ROS1 rearrangement, BRAF mutation, or NTRK fusion with available standard therapies
- Symptomatic or unstable CNS metastasis requiring steroid dose increase; controlled CNS metastasis allowed
- Prior exposure to MET-directed therapy (except METex14 skipping in Phase Ib)
- Past or current malignancies other than NSCLC (except specific treated cancers with no disease for 5 years)
- Significant cardiovascular disease including severe heart failure, serious arrhythmias, recent myocardial infarction or unstable angina, low LVEF, prolonged QTcF interval, congenital long QT syndrome, or uncontrolled hypertension
- Unresolved toxicities from prior therapy greater than grade 1, except alopecia and grade 2 neuropathy
- Known HIV infection with AIDS-defining infections in past 12 months, active hepatitis B or C as specified
- Recent anticancer therapy within 4 weeks or 5 half-lives
- Recent radical radiation therapy within 4 weeks or local palliative radiation within 2 weeks
- Major surgery or significant injury within 28 days
- Use of prohibited medications such as strong CYP3A4 inhibitors or inducers or drugs prolonging QTc
- Unstable medical conditions or diseases that could affect safety or compliance
- History of interstitial lung disease or active ILD
- Pregnant or breastfeeding women
- Men and women of childbearing potential not using effective contraception during and 6 months after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 44 locations
1
Norton Cancer Institute
Louisville, Kentucky, United States, 40233
Not Yet Recruiting
2
The Oncology Institute of Hope & Innovation
Louisville, Kentucky, United States, 40233
Actively Recruiting
3
Anhui Province Hospital
Hefei, Anhui, China, 230000
Actively Recruiting
4
The Chest Hospital of Anhui Province
Hefei, Anhui, China, 230000
Actively Recruiting
5
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
6
Beijing Cancer Hospita
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
7
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
8
Union Medical College Hospital Affiliated to Fujian Medical University
Fuzhou, Fujian, China, 350000
Actively Recruiting
9
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
10
Cancer Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, China, 530000
Actively Recruiting
11
Hainan Cancer Hospital
Haikou, Hainan, China, 570000
Actively Recruiting
12
Cancer Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang, China, 150000
Actively Recruiting
13
Henan Province Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
14
Hubei Cancer Hospital
Wuhan, Hubei, China, 430000
Actively Recruiting
15
Wuhan Union Hospital
Wuhan, Hubei, China, 430000
Actively Recruiting
16
Xiangya Hospital Central South University
Changsha, Hunan, China, 410000
Actively Recruiting
17
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
18
Jiangsu Province People's Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
19
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330000
Actively Recruiting
20
First Hospital of Jilin University
Changchun, Jilin, China, 130000
Actively Recruiting
21
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110000
Actively Recruiting
22
Affiliated Hospital of Hebei University
Baoding, Shandong, China, 071000
Actively Recruiting
23
Shandong University Qilu Hospital
Jinan, Shandong, China, 250000
Actively Recruiting
24
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
25
Fudan university Shanghai cancer center
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
26
The Chest Hospital of Shanghai
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
27
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
28
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
29
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
30
The First Affiliated Hospital，College of of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
31
Zhejiang Province Cancer Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
32
Hunan Province Cancer Hospital
Changsha, China, 410000
Actively Recruiting
33
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China, 450000
Actively Recruiting
34
Ehime University Hospital
Ehime, Japan
Actively Recruiting
35
Kyushu University Hospital
Fukuoka, Japan
Actively Recruiting
36
Kanagawa Cancer Center
Kanagawa, Japan
Actively Recruiting
37
Niigata Cancer Center Hospital
Niigata, Japan
Actively Recruiting
38
Kindai University Hospital
Osaka, Japan
Actively Recruiting
39
Osaka International Cancer Institute
Osaka, Japan
Actively Recruiting
40
Hokkaido University Hospital
Sapporo, Japan
Actively Recruiting
41
Shizuoka Cancer Center
Shizuoka, Japan
Actively Recruiting
42
National Cancer Center Hospital East
Tokyo, Japan
Actively Recruiting
43
National Cancer center
Tokyo, Japan
Actively Recruiting
44
Tottori University Hospital
Tottori, Japan
Actively Recruiting
Research Team
S
Shun LU, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here