NCT04270591 · Haihe Biopharma Co., Ltd.
Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer
What this study 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)
View original scientific description
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)
Interventions
DRUG
Glumetinib
The investigational product will be orally administrated when fasting at dose level of 300mg QD
Primary outcome measures
ORR
Time frame: through study completion, an average of 1 year
ORR as determined by an Independent Radiology Review Committee (IRRC) according to RECIST Version 1.1.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provide informed consent voluntarily. 2. Male and female patients ≥ 18 years of age (or having reached the age of majority according to local laws and regulations, if the age is \> 18 years). 3. Histologically or cytologically confirmed diagnosis of NSCLC including PSC. 4. Patients with stage IIIb or IIIc NSCLC who are not candidates for definitive surgical resection or concurrent chemoradiation or patients with stage IV NSCLC (AJCC version 8). 5. For Phase Ib study, patients should carry at least one of the following MET alterations (by local or Sponsor-designated central laboratory screening):
- METex14 skipping mutation who had previously treated by other MET inhibitor(s) or
- METex14 skipping mutation who had received 3 or more lines prior systemic therapies without MET inhibitor for the advanced NSCLC or
- MET amplification GCN ≥ 4 or MET/CEP7 ratio ≥ 2) or
- MET over-expression (IHC2+). 6. For Phase II study, patients with METex14 skipping mut
Where
- Louisville, Kentucky
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 1, 2022 · Source of record for eligibility and locations