Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI
Recruiting · NCT06343064 · Interventional (participants receive a specific treatment) · Lead sponsor: Avistone Biotechnology Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET Amplified or MET Expression in NSCLC
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Ability to understand and willingness to sign a written informed consent document.
- Aged at least 18 years old.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB\~IV).
- EGFR mutations, including exon 19 deletion and exon 21 L858R.
- C-Met overexpression and/or c-Met amplification confirmed after treatment with EGFR-TKI.
- At least one measurable lesion as defined by RECIST V1.1.
- ECOG performance status 0 to 1.
Exclusion criteria
- Previous treatment with MET inhibitors or HGF-targeted therapy.
- There are mutations of ALK or ROS1.
- Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control.
- Pregnant or nursing women.
Where it is running
1 location listed.
- Shanghai Pulmonary Hospital - Shanghai, Shanghai Municipality, China