Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.
A Phase II Study of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.
Avistone Biotechnology Co., Ltd.
120 participants
Aug 7, 2024
INTERVENTIONAL
Summary
Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.
Eligibility
Inclusion Criteria6
- 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 Criteria3
- 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.
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Interventions
Subjects will receive Vebreltinib orally twice per day (BID).
Subjects will receive Osimertinib 80mg orally once per day (QD).
Subjects will receive PLB1004 80mg orally once per day (QD).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06574347