Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.
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+) .
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.
Parallel
Vebreltinib
DrugSubjects will receive Vebreltinib orally twice per day (BID).
Osimertinib
DrugSubjects will receive Osimertinib 80mg orally once per day (QD).
PLB1004
DrugSubjects will receive PLB1004 80mg orally once per day (QD).
The objective response rate of the tumor (ORR)
The incidence of confirmed complete response or partial response.
The disease control rate (DCR)
The incidence of complete response, partial response and stable disease.
Duration of Response (DoR)
The duration between the date the criteria for complete response or partial response was first measured (first record shall prevail) and the date of disease recurrence or progression as objectively recorded.
Progression-free survival (PFS)
Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Time to Response (TTR)
The period from the date of randomization to the date when the criteria for complete response or partial response was first measured (first record shall prevail).
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