RecruitingPhase 1Phase 2NCT06343064

Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI

A Phase Ib/II Study of Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI


Sponsor

Avistone Biotechnology Co., Ltd.

Enrollment

156 participants

Start Date

Jun 13, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET Amplified or MET Expression in NSCLC


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests combining two targeted drugs — vebreltinib (a MET inhibitor) and PLB1004 (a third-generation EGFR inhibitor) — for patients with advanced lung cancer that initially responded to EGFR-targeted therapy but has since developed resistance through a MET pathway change. **You may be eligible if...** - You are 18 or older with confirmed advanced or metastatic non-small cell lung cancer - Your tumor has an EGFR mutation (exon 19 deletion or L858R) - Your tumor has developed MET amplification or MET overexpression after EGFR-targeted therapy - You have at least one measurable tumor lesion - You are in generally good health (ECOG 0–1) **You may NOT be eligible if...** - You have previously received a MET inhibitor or anti-HGF therapy - Your tumor also has ALK or ROS1 alterations - You have symptomatic brain metastases requiring increasing steroid doses - 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

Phase Ib is a dose escalation study, the initial dose of Vebreltinib is 100mg/150mg/200mg,according to the result of Phase Ib, will confirm the RP2D.

DRUGPLB1004

Phase Ib is a dose escalation study, the initial dose of PLB1004 is 80mg/160mg,according to the result of Phase Ib, will confirm the RP2D.


Locations(1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

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NCT06343064


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