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

NCT05382728 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2024-01-30

No results posted yet for this study

Summary

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

Conditions

  • NSCLC
  • EGFR Activating Mutation

Interventions

DRUG

TY-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.

DRUG

placebo 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.

DRUG

Osimertinib

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.

DRUG

placebo 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.

Sponsors & Collaborators

  • TYK Medicines, Inc

    lead INDUSTRY

Principal Investigators

  • Baohui Han, MD · Shanghai Chest Hospital

  • Lin Wu, MD · Hunan Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-08
Primary Completion
2025-05-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05382728 on ClinicalTrials.gov