RecruitingPhase 2NCT05751018

Phase II Clinical Study of Pyrotinib in First-line Treatment of Primary HER2-amplified/Mutated Advanced Non-small Cell Lung Cancer


Sponsor

Peking Union Medical College Hospital

Enrollment

18 participants

Start Date

Dec 8, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, single-arm phase II clinical study to evaluate the safety and efficacy of pyrotinib maleate as a first-line treatment for HER2-mutated or amplified non-small cell lung cancer. Pyrotinib maleate is a small molecule tyrosine kinase inhibitor that can irreversibly inhibit HER1, HER2, and HER4.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether pyrotinib — a targeted therapy drug — can be used as a first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) that has a HER2 genetic mutation or amplification. Currently, there are limited approved treatments targeting HER2 in lung cancer. **You may be eligible if...** - You are 18 or older with Stage IIIB or IV non-small cell lung cancer - Your cancer has a confirmed HER2 insertion mutation, point mutation, or amplification (found by genetic testing) - You have not had any prior systemic treatment for advanced-stage lung cancer - You have at least one measurable tumor - Your heart function (left ventricular ejection fraction) is at least 50% - Your blood counts, kidney, and liver function are adequate **You may NOT be eligible if...** - Your cancer is HER2-negative or has a different driver mutation treated by another targeted therapy - You have previously received any systemic treatment for advanced lung cancer - You have active brain metastases that are symptomatic or untreated - You have significant heart, kidney, or liver problems 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

DRUGPyrotinib

Pyrotinib maleate is a small molecule tyrosine kinase inhibitor that can irreversibly inhibit HER1, HER2, and HER4.


Locations(1)

Peking Union Medical College

Beijing, Beijing Municipality, China

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NCT05751018


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