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Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.

Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.

Recruiting
18 years and older
All
Phase 2

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Overview

Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.

Description

A Multicenter,Randomized,open-label,Phase II Study to Evaluate the Efficacy and Safety of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients with EGFRm+(exon 19 deletion or exon 21 L858R)/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.

Eligibility

Inclusion Criteria:

  1. Ability to understand and willingness to sign a written informed consent document.
  2. Aged at least 18 years old.
  3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB~IV).
  4. Patients with previously untreated, EGFRm-positive (exon 19 deletion or L858R) and MET overexpression (IHC 3+) .
  5. At least one measurable lesion as defined by RECIST V1.1.
  6. ECOG performance status 0 to 1.

Exclusion Criteria:

  1. There are mutations of ALK or ROS1.
  2. Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control.
  3. Pregnant or nursing women.

Study details
    Non-Small-Cell Lung Cancer

NCT06574347

Avistone Biotechnology Co., Ltd.

15 October 2025

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