RecruitingPhase 3NCT05382728

Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)

A Phase III, Randomised, Double-blind, Multi-center Study to Assess the Efficacy and Safety of TY-9591 Tablets Versus Osimertinib as First Line Treatment in Patients With EGFR-sensitive Mutation, Locally Advanced or Metastatic Non Small Cell Lung Cancer.

Sponsor

TYK Medicines, Inc

Enrollment

680 participants

Start Date

Jun 8, 2022

Study Type

INTERVENTIONAL

Conditions

NSCLC EGFR Activating Mutation

Summary

To assess the efficacy and safety of TY-9591 versus Osimertinib in patients with locally advanced or Metastatic Non Small Cell Lung Cancer.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted drug called TY-9591 for people with advanced or metastatic non-small cell lung cancer (NSCLC) — a type of lung cancer that has spread and cannot be removed by surgery. Researchers want to see if TY-9591 works better than existing treatments for patients whose tumors carry a specific genetic mutation called an EGFR mutation. **You may be eligible if...** - You are between 18 and 79 years old - You have been diagnosed with advanced or metastatic non-small cell lung cancer - Your tumor has a specific genetic mutation in the EGFR gene (such as exon 19 deletion or L858R) - You have not had any prior drug treatment for advanced or metastatic lung cancer - You are in reasonably good overall health (able to carry out light activities) - Your blood, liver, and kidney function are within normal range **You may NOT be eligible if...** - You have previously taken an EGFR-targeted drug (such as erlotinib, gefitinib, or osimertinib) - You have had chemotherapy or other cancer drug treatment for your advanced lung cancer - You have squamous cell lung cancer - You have active, symptomatic brain metastases - You have significant heart rhythm problems or reduced heart pump function - 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 is 160 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

DRUGplacebo Osimertinib

The dose of placebo Osimertinib is 80 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence 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. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

DRUGplacebo TY-9591

The dose of placebo TY-9591 is 160 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

Locations(2)

Hunan Provincial Tumor Hospital

Changsha, Hunan, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT05382728

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