Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.
- Conditions
- Non-Small-Cell Lung Cancer
- Registration Number
- NCT06574347
- Lead Sponsor
- Avistone Biotechnology Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria:<br><br> 1. Ability to understand and willingness to sign a written informed consent document.<br><br> 2. Aged at least 18 years old.<br><br> 3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC<br> (stage IIIB~IV).<br><br> 4. Patients with previously untreated, EGFRm-positive (exon 19 deletion or L858R) and<br> MET overexpression (IHC 3+) .<br><br> 5. At least one measurable lesion as defined by RECIST V1.1.<br><br> 6. ECOG performance status 0 to 1.<br><br>Exclusion Criteria:<br><br> 1. There are mutations of ALK or ROS1.<br><br> 2. Have symptomatic and neurologically unstable central nervous system (CNS) metastases<br> or CNS disease that requires increased steroid doses for control.<br><br> 3. Pregnant or nursing women.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The objective response rate of the tumor (ORR)
- Secondary Outcome Measures
Name Time Method The disease control rate (DCR);Duration of Response (DoR);Progression-free survival (PFS);Time to Response (TTR);Incidence of Treatment-Emergent Adverse Events