RecruitingPhase 2NCT05948813

TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases

A Phase II Study of TY-9591 Tablets in Patients With EGFR-Mutated Non-small Cell Lung Cancer With Brain Metastases


Sponsor

TYK Medicines, Inc

Enrollment

420 participants

Start Date

Aug 17, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is to evaluate the efficacy and safety of TY-9591 in first-line treatment of patients with EGFR-sensitive mutation-positive non-small cell lung cancer with brain metastases compared to Osimertinib.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing TY-9591 — a new targeted therapy that blocks a protein called EGFR — in people with advanced non-small cell lung cancer (NSCLC) that has spread to the brain. The drug is designed to cross the blood-brain barrier, addressing a challenge that many lung cancer treatments face. **You may be eligible if...** - You are between 18 and 80 years old with NSCLC confirmed by biopsy or cytology - Your tumor has an EGFR mutation (exon 19 deletion, L858R, or similar) - You have stable brain metastases that do not need immediate treatment - You have not yet received systemic (whole-body) treatment for advanced NSCLC - You are in good physical condition (ECOG 0–1) **You may NOT be eligible if...** - You have previously received any EGFR inhibitor or systemic cancer treatment - You have had whole-brain radiation therapy - Your brain metastases are unstable or require urgent treatment - You have serious heart problems, interstitial lung disease, or active viral infections - 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

DRUGTY-9591

The dose of TY-9591 tablet is 160 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment until meet the of discontinuation criteria.

DRUGOsimertinib

The dose of Osimertinib is 80 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment until meet the of discontinuation criteria.


Locations(1)

National Cancer Center/Cancer Hospitial,Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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NCT05948813


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