Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT05948813

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

Led by TYK Medicines, Inc · Updated on 2024-11-21

420

Participants Needed

1

Research Sites

228 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 years and under 80 years
  • Diagnosed with NSCLC by histology or cytology, with brain metastases
  • Presence of activating EGFR-sensitive mutations (including exon 19 deletions, L858R, alone or with other EGFR mutations)
  • No prior systemic antitumor therapy for locally advanced or metastatic NSCLC
  • Stable brain metastases not requiring immediate or planned local treatment during the study
  • At least one measurable lesion per RECIST version 1.1
  • ECOG performance status 0-1, with no deterioration 2 weeks before the study, expected survival at least 3 months
  • Adequate bone marrow function and no liver, kidney, or coagulation dysfunction
  • Use of effective contraception from consent to 3 months after last study drug; women of childbearing age with negative pregnancy test within 7 days before first dose
  • Recovery from prior anticancer therapy toxicities grade 1 or less (except alopecia and certain neuropathies) before first dose
  • Ability to understand and voluntarily sign informed consent
  • Ability to comply with study requirements
Not Eligible

You will not qualify if you...

  • Previous treatment with EGFR inhibitors or systemic antitumor therapy (targeted, biotherapy, immunotherapy)
  • Prior chemotherapy within 28 days or traditional Chinese medicine antitumor therapy within 7 days before first dose
  • Prior whole brain radiation therapy or recent radiation affecting bone marrow or limited field radiation within 7 days
  • Uncontrollable or poorly controlled pleural, abdominal, or pericardial effusion
  • Uncontrollable cancer pain or unstable painkiller dosing at enrollment
  • Major surgery within 28 days before first dose
  • Use of medications or supplements that strongly affect CYP3A4 within 14 days before first dose
  • Use of medications prolonging QTc interval or causing tachycardia that must continue during study
  • Participation in other clinical trials (except non-interventional) within 28 days before first dose
  • Primary malignant brain tumors or unstable brain metastases
  • History of other malignancies within 5 years (except certain cured skin, thyroid, cervical, or breast cancers)
  • Symptoms of spinal cord compression from tumor
  • Severe gastrointestinal dysfunction affecting drug absorption
  • Cardiac abnormalities including QTc >470 ms, rhythm issues, risk factors for QTc prolongation, or LVEF <50%
  • Active HIV, syphilis, hepatitis C or B infections (except asymptomatic carriers)
  • Past interstitial lung disease or radiation pneumonitis requiring steroids, or active ILD
  • Previous allogeneic bone marrow transplant
  • Pregnant or breastfeeding women
  • Any unstable medical condition affecting safety or compliance
  • Hypersensitivity to TY-9591 or similar compounds or excipients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

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Research Team

Y

Yuankai Shi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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