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

RECRUITINGPHASE2

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.

NCT06574347•Avistone Biotechnology Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Key Dates

Start Date

August 7, 2024

Primary Completion Date

October 31, 2026

Completion Date

July 31, 2027

Last Updated

May 21, 2025

Enrollment

120

ESTIMATED participants

Conditions

Non-Small-Cell Lung Cancer

Interventions

Vebreltinib

DRUG

Osimertinib

DRUG

PLB1004

DRUG

Contacts

Liang Lin

CONTACT

08-10-84148931 linliang@avistonebio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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