Glumetinib for c-MET-positive Non-Small Cell Lung Cancer
This study is testing a drug called glumetinib for people with advanced non-small cell lung cancer (NSCLC) that has a specific change in the c-MET gene (c-MET-positive). Glumetinib is given by mouth once a day. Researchers want to see how well glumetinib shrinks tumors and if it is safe. To join, you must be between 18 and 80 years old and have NSCLC with certain c-MET gene changes. The study will measure how many patients respond to the treatment over about one year. The study plans to enroll 183 participants, but its current status is unclear.
- Study design
- This interventional study is designed in two parts: an initial Phase Ib in China with about 90 patients, followed by a global Phase II with about 78 evaluable patients. It is not specified if it's randomized or blinded.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, overall response rate (ORR), is measured through study completion, which is an average of one year.
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NCT04270591
Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer
Recruiting
PHASE1Ages 18–80InterventionalTreatmentHaihe Biopharma Co., Ltd.
~183 participants
Updated 2022-08-01 on ClinicalTrials.gov
What's tested:Glumetinib
At a glance
Recruiting sites
43 of 44 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
ORR
Measured over through study completion, an average of 1 year
Conditions
Where it's being run
44 sites across 22 statesJapan11
Beijing Municipality3
Shanghai Municipality3
Kentucky2
Anhui2
Hubei2
Jiangsu2
Shandong2
Study leadership
- James Zhou, MD · STUDY_DIRECTOR · Haihe Biopharma
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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 mutation in tumor or ctDNA samples (local testing is acceptable for eligibility, however if the results of the central laboratory is available, the report of the central laboratory shall prevail); all patients in Phase II study will have confirmation of METex14 skipping mutation by Sponsor-designated central laboratory but this result is not necessary for eligibility. 7. Availability of tumor tissue sample (either fresh tumor biopsy or archival tumor tissue sample); for patients of phase II study (not mandatory for safety run-in), if screened and enrolled based on local test results of METex14 skipping, the tumor tissue sample must be available for central laboratory testing before C2D1; if local testing results meet the requirements, patients of phase Ib are exempt from the central laboratory confirm. 8. For Phase II study, patients are not eligible for chemotherapy or refuse chemotherapy after well-informed or have failed one or two prior lines of systemic therapies for the advanced NSCLC.
Treatment failure is defined as documented disease progression or intolerance to treatment.
Maintenance therapy given after first line chemotherapy will be considered as part of the first line if given to patients with documented response or stable disease before starting the maintenance therapy.
Prior neoadjuvant/adjuvant systematic therapies will count as one prior line of treatment, provided that disease recurred within 12 months of completion of neoadjuvant/adjuvant therapy. 9. For Phase II study, at least one measurable lesion as per RECIST 1.1. (A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation.) 10. ECOG Performance Status (PS): 0-1. 11. Adequate bone marrow reserve, renal and liver function:
Absolute neutrophil count ≥ 1.5 × 109/L;
Hemoglobin ≥ 9 g/dL;
Platelet count ≥ 75 × 109/L;
Serum total bilirubin ≤ ULN (≤ 3 × ULN for patients with Gilbert's syndrome);
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5.0 × ULN for patients with hepatic metastasis);
Creatinine clearance (calculated\* or measured value\*\*) ≥ 50 mL/min
For calculated creatinine clearance (Ccr) value, the eligibility should be determined using the Cockcroft-Gault formula:
Male Ccr (mL/mim) = body weight (kg) x (140-age)/\[72 x creatinine (mg/dL)\]
Female Ccr (mL/min) = male Ccr x 0.85 \*\* A measured value
International normalized ratio (INR) \< 1.3 (or \< 3.0 if on anticoagulation)
Exclusion
NYHA Class III or higher congestive heart failure;
History or current evidence of serious uncontrolled ventricular arrhythmias requiring drug therapy;
Acute myocardial infarction, severe or unstable angina pectoris, coronary artery or peripheral artery bypass graft received within 6 months prior to the first dose;
Left ventricular ejection fraction (LVEF) \< 50%;
Fridericia's corrected QT interval (QTcF) \> 460 ms on ECG conducted during screening;
Congenital long QT syndrome, or any known history of torsade de pointes (TdP), or family history of unexplained sudden death;
Clinically uncontrolled hypertension (after standard antihypertensive treatment, systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg); 6. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia and grade 2 prior neuropathy. 7. Known HIV infection with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunity infection within the past 12 months; active hepatitis B and hepatitis C. Patients whose test results meet one of the following will not be enrolled:
for patients in China and Japan, confirmed HIV antibody positive. For patients in the US, patients with a history of HIV but no history of AIDS or an AIDS-defining opportunistic infection are allowed to be enrolled;
serum HBsAg positive and HBV DNA\>200 IU/ml or 1000 copies/mL;
serum HCV antibody and HCV RNA positive. 8. Anticancer therapy (including chemotherapy, targeted therapy, biotherapy, hormone therapy or other investigational agents) within 4 weeks or 5 times of half-lives (whichever is shorter) prior to the first dose of the study drug or who have not recovered from the side effect of such therapy. 9. Radical radiation therapy (including radiation therapy for over 25% bone marrow) within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks. 10. Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product. 11. Patients who have to receive treatment (definite strong CYP3A4 inhibitor or inducer \[appendix 6\]; in addition, herbals/supplements containing St. John's wart \[Hypericum perforatum L.\] and Sevillia orange etc. should also be avoided.) that is prohibited during the study and those who cannot discontinue drugs (e.g. antiarrhythmic agent) that may lead to QTc interval prolongation or torsade de pointes. Additionally, patients who have to receive treatment of strong inhibitor for CYP2C8 and/or CYP2C9 \[appendix 6\] and substrates or inhibitor for transporter \[appendix 7\] will be excluded in safety run-in part of the study. 12. Any diseases or medical conditions, at the investigator's discretion, that may be unstable or influence their safety or study compliance, including organ transplantation, abuse of psychotropic medication, alcohol abuse or history of drug abuse. 13. Other serious illness or medical conditions at the investigator's discretion, that may influence study results, including but not limited to serious infection, diabetes, cardiovascular and cerebrovascular diseases or lung disease. 14. Patients with a history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment or any evidence of clinically active ILD. 15. Pregnant or breast-feeding patients. Pregnancy refers to the state of a woman between fertilization and the end of pregnancy confirmed by positive laboratory hCG test (\> 5 mIU/mL). Breast-feeding woman can become eligible for this study if she stops breast-feeding, however, cannot restart the breast-feeding on/after the completion of the study treatment. 16. Man and woman with childbearing potential (WOCBP refer to appendix 3) not using effective contraception (refer to appendix 3) during the trial and within 6 months after the end of treatment
What this trial measures
- ORRthrough study completion, an average of 1 year
ORR as determined by an Independent Radiology Review Committee (IRRC) according to RECIST Version 1.1.