RecruitingPhase 2NCT06574347

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.


Sponsor

Avistone Biotechnology Co., Ltd.

Enrollment

120 participants

Start Date

Aug 7, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two targeted drugs — vebreltinib (a MET inhibitor) and PLB1004 (an EGFR inhibitor) — as first-line treatment for people with advanced non-small cell lung cancer (NSCLC) that has two specific molecular changes: an EGFR mutation and MET overexpression. These genetic changes make the cancer sensitive to this combination. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic NSCLC (stage IIIB–IV) confirmed by biopsy - Your cancer has a specific EGFR mutation (exon 19 deletion or L858R) - Your cancer also has MET overexpression (IHC 3+) - You have not received any prior systemic treatment for your lung cancer - Your performance status is ECOG 0–1 **You may NOT be eligible if...** - Your cancer has ALK or ROS1 mutations (different targets) - You have unstable brain metastases requiring steroids - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVebreltinib

Subjects will receive Vebreltinib orally twice per day (BID).

DRUGOsimertinib

Subjects will receive Osimertinib 80mg orally once per day (QD).

DRUGPLB1004

Subjects will receive PLB1004 80mg orally once per day (QD).


Locations(1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

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NCT06574347


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