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TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT05948813•TYK Medicines, Inc

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.

Detailed Description

This is an open label, multi-center phase II study to compare the efficacy and safety with Osimertinib in EGFR mutated NSCLC patients with brain metastases. Participants will be randomly assigned to one of the TY-9591 group (160mg orally, once daily) or Osimertinb group (80mg orally, once daily) . Participants can continue to receive study treatment as long as disease progression, meeting criteria for discontinuation of treatment, withdrawal criteria, or study termination (whichever occurred first).

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female aged ≥18 years and \<80 years.
•2. Patients diagnosed with NSCLC by histology or cytology, with brain metastases.
•3. Presence of an activating EGFR-sensitive mutations (including exon 19 deletions, L858R, the above mentioned mutations alone or co-existed with other EGFR-mutated sites).
•4. No prior systemic antitumor therapy for locally advanced or metastatic NSCLC.
•5. Stable brain metastases that do not require immediate or planned local treatment for it during the study period.
•6. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
•7. The ECOG score is 0-1, and there is no deterioration 2 weeks before the study, and the expected survival is not less than 3 months.
•8. Adequate bone marrow reserve function, and no liver, kidney and coagulation dysfunction.
•9. Male patients and female patients of reproductive age should take adequate contraceptive measures from signing informed consent to 3 months after the last study drug treatment; Women of childbearing age have negative pregnancy test results within 7 days of the first dose.
•10. Patients having recovered from all grade ≤ 1 toxicities related to previous anticancer therapies (CTCAE v 5.0) except for alopecia, platinum-therapy-related neuropathy (where ≤2 is allowed) before first dose of study treatment.
+2 more criteria

Exclusion Criteria

•1. Any of the following treatment:
•1. Previous treatment with EGFR inhibitor;
•2. Previous treatment with Systematic antitumor therapy (including targeted therapy, biotherapy and immunodrug therapy, etc.)；
•3. Previous treatment with standard chemotherapy with 28 days before the first dose of the study drug, and traditional Chinese medicine antitumor therapy within 7 days before the first dose of the study drug;
•4. Previous whole brain radiation therapy (WBRT); Receiving radiation to more than 30% of the bone marrow or with a wide field of radiation that had to be completed within 28 days of the first dose of study treatment; Radiotherapy with a limited field of radiation within 7 days of the first dose of study treatment or palliative radiation therapy for bone metastasis;
•5. Uncontrollable or poorly controlled pleural, abdominal and pericardial effusion;
•6. Uncontrollable cancerous pain; Anesthetic painkillers did not reach a stable dose at the time of enrollment;
•7. Major surgery within 28 days of the first dose of study treatment;
•8. Patients currently receiving (or at least within 14 days prior to receiving the first dose )medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 isoenzyme (CYP)3A4;
•9. Patients who are receiving and need to continue receiving medications during the study that are known to prolong the QTc interval or may cause tachycardia;
+16 more criteria

Locations (1)

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

Beijing, Beijing Municipality, China

Key Dates

Start Date

August 17, 2023

Primary Completion Date

June 30, 2025

Completion Date

December 30, 2027

Last Updated

November 21, 2024

Enrollment

420

ESTIMATED participants

Conditions

NSCLCEGFR Activating MutationBrain Metastases

Interventions

TY-9591

DRUG

Osimertinib

DRUG

Contacts

Yuankai Shi, MD

CONTACT

+86-10-87788293 syuankaipum@126.com

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NCT07486219

Lung Cancer (NSCLC)

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Non-small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Magnetic Resonance Imaging of the Lung: Oncological Applications

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

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Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers