Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.
Recruiting · NCT06574347 · 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 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic 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 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).
- Patients with previously untreated, EGFRm-positive (exon 19 deletion or L858R) and MET overexpression (IHC 3+) .
- At least one measurable lesion as defined by RECIST V1.1.
- ECOG performance status 0 to 1.
Exclusion criteria
- 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.
- Guangdong Provincial People's Hospital - Guangzhou, Guangdong, China