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Recruiting NCT06574347

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

Phase II Interventional Non-Small-Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vebreltinib, Osimertinib, PLB1004.
Who it may be relevant to
Registry conditions: Non-Small-Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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

Detailed 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.

Interventions

  • Drug Vebreltinib
    Subjects will receive Vebreltinib orally twice per day (BID).
  • Drug Osimertinib
    Subjects will receive Osimertinib 80mg orally once per day (QD).
  • Drug PLB1004
    Subjects will receive PLB1004 80mg orally once per day (QD).

Primary outcome measures

  • The objective response rate of the tumor (ORR) [Time frame: 2 Years]
Secondary outcome measures (5)
  • The disease control rate (DCR) [Time frame: 2 Years]
  • Duration of Response (DoR) [Time frame: 2 Years]
  • Progression-free survival (PFS) [Time frame: 2 Years]
  • Time to Response (TTR) [Time frame: 2 Years]
  • Incidence of Treatment-Emergent Adverse Events [Time frame: 2 Years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Guangdong Provincial People's Hospital — Guangzhou

Identifiers

NCT: NCT06574347 · PLB1001/PLB1004-NSCLC-II-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗