Actively Recruiting
A Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in Non-Small Cell Lung Cancer Patients After Resistance to EGFR-TKIs
Led by Shanghai JMT-Bio Inc. · Updated on 2025-04-08
350
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The is a randomized, controlled, open-label Phase III clinical study to evaluate the efficacy and safety of glumetinib combined with osimertinib mesylate versus platinum-based doublet chemotherapy in non-small cell lung cancer( NSCLC) patients with MET amplification and/or overexpression after resistance to EGFR-TKIs.. Approximately 350 NSCLC patients with MET amplification and/or overexpression after previous treatment with EGFR-TKIs are planned to be enrolled. After patients sign the informed consent form (ICF), those who are eligible for enrollment after screening examinations will be randomized to the investigational group or the control group in a 1:1 ratio by the central randomization system (IWRS).
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in Non-Small Cell Lung Cancer Patients After Resistance to EGFR-TKIs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients able to understand and voluntarily sign the informed consent form
- Male or female patients aged 18 years or older
- Histologically or cytologically confirmed non-small cell lung cancer that is unresectable, locally advanced, or metastatic (Stage IIB, IIC, or III)
- Confirmed EGFR-sensitive mutations before first-line treatment with EGFR-TKIs
- Documented disease progression after treatment with first-, second-, or third-generation EGFR-TKIs
- For patients with prior adjuvant EGFR-TKI treatment after surgery, progression occurred within 6 months after last dose
- MET amplification and/or overexpression confirmed after progression following EGFR-TKI treatment, based on central laboratory tests
- At least one measurable lesion according to RECIST v1.1 criteria (brain metastases not considered as target lesions)
You will not qualify if you...
- Prior treatment with targeted MET drugs
- Presence of T790M-positive mutation after progression following first- or second-generation EGFR-TKI treatment
- Positive for other driver gene mutations such as ALK or ROS1 after progression following EGFR-TKI treatment
- Prior systemic anti-tumor therapy for advanced NSCLC other than EGFR-TKIs, including chemotherapy and immunotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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