To evaluate the efficacy and safety of glumetinib in elderly patients with advanced non-small cell lung cancer with MET amplification or protein overexpression

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400092808

Enrollment

Unknown

Registered

2024-11-25

Start date

2024-11-25

Completion date

Unknown

Last updated

2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

Interventions

Test group:Glumetinib

Eligibility

Sex/Gender

All

Age

70 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Ages =70years; 2. With inoperable locally advanced (stage IIIb, IIIc) and metastatic non-small cell lung cancer with MET amplification or overexpression confirmed by histopathology or cytology; 3. No previous systemic therapy (initial treatment) or one previous chemotherapy; 4. MET amplification FISH(MET GCN=4 or MET/CEP7=1.8) or NGS(MET GCN=5); 5. MET over expression IHC 3+; 6. ECOG 0-2; 7. Life expectancy of at least 3 months; 8. Bone marrow function: ANC =1.5×10^9/L, PLT=100×10^9/L, Hb =90g/L, WBC=3.0×10^9/L; 9. Liver function: ALT/AST=2.5×ULN, liver metastases ALT/AST=5×ULN; TBil =1.5×ULN; 10. Renal function: Cr=1.5×ULN or CCr=50mL/min (Cockcroft-Gault); 11. At least one measurable target lesion prior to initial administration of glumetinib (according to RECIST 1.1); 12. Subjects were fully aware of and voluntarily enrolled in the study, and were compliant and willing to be followed up.

Exclusion criteria

Exclusion criteria: 1. Because of a gastrointestinal disease or other condition that may affect the absorption of the trial drug (e.g. inability to swallow the drug, severe ulcers, uncontrollable nausea, vomiting, and diarrhea, malabsorption syndrome, ulcerative colitis, extensive removal of the stomach and small intestine, etc.); 2. Serious, uncontrolled concomitant diseases that may affect the results of the study, including but not limited to serious infections, diabetes, cardiovascular and cerebrovascular diseases, or lung diseases; 3. With known HIV infection and a history of acquired immunodeficiency syndrome (AIDS), opportunistic infection, active hepatitis B or C within the past 12 months; 4. Symptomatic brain metastasis or meningeal metastasis; 5.Treated with other antitumor agents; 6. Concomitant with other malignancies requiring treatment; 7. The investigators determined that patients were not suitable for participation in the study.

Design outcomes

Primary

Measure	Time frame
Objective response rate;	—

Secondary

Measure	Time frame
Overall survival;Progressive Free Survival;Safety;Disease control rate;Duration of response;	—

Countries

China

Contacts

Public ContactLi Lin

Beijing Hospital

lilin_51@hotmail.com+86 136 0122 7591

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026