NSCLC
Conditions
Interventions
Cohort 1: Untreated non-small cell lung cancer in patients with brain metastases and MET alterations:Glumetinib (300mg) will be administered orally in a 4-week treatment cycle, once a day from day 1 t
Cohort 2: EGFR-TKI resistant non-small cell lung cancer in patients with brain metastases and MET alterations:Glumetinib+Furmonertinib
Glumetinib (300mg) will be administered orally in a 4-week treatm
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years. 2. Histologically or cytologically confirmed non-small cell lung cancer with brain metastases and MET alterations. 3. Brain metastasis confirmed by CT or MRI. 4. Patients with MET alterations (including MET exon 14 skipping mutation, MET 14 amplification, etc). 5. ECOG (Eastern Cooperative Oncology Group) performance status of 0-3. 6. Expected survival time greater than 3 months. 7. The organ function of the patient is normal, and the functions of important organs meet the following requirements: (1) Blood routine test: a) hemoglobin = 80 g/L b) neutrophils = 1.5 x 10^9/L c) platelet = 75 x 10^9/L (2) Biochemical tests a) ALT/AST = 2.5 x ULN; When there is liver metastasis, ALT/AST = 5 x ULN b) total bilirubin = 2 x ULN c) Cr =1.5×ULN 8. The subjects voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Due to gastrointestinal diseases or other conditions that may impair the absorption of the trial drug, such as difficulty swallowing, severe ulcers, uncontrollable nausea, vomiting, diarrhea, malabsorption syndrome, ulcerative colitis, or extensive gastric and small intestinal resection. 2. Serious and uncontrollable concomitant diseases that may affect the research results, including but not limited to serious infections, diabetes, cardiovascular and cerebrovascular diseases, or lung diseases, etc. 3. Pregnant or lactating women. 4. Patients with known HIV infection and a history of acquired immunodeficiency syndrome (AIDS), opportunistic infections, active hepatitis B or hepatitis C within the past 12 months. 5. Males of childbearing potential or females with the possibility of becoming pregnant are not allowed to use highly effective contraceptive methods during the trial until 1 week after the end of treatment. 6. Participants who were judged by the investigator to be unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Intracranial progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease Control Rate;Duration of Response;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactXiaoyan Li
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed