Status and phase
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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.
Full 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).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Any of the following treatment:
Patients with primary malignant brain tumors and unstable brain metastases.
Patients who have had or have a history of other malignancies within the past 5 years (except cured basal cell or squamous cell carcinoma of the skin, papillary carcinoma of the thyroid gland, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast).
The patient had symptoms of spinal cord compression caused by the tumor.
Clinically severe gastrointestinal dysfunction may affect the ingestion, transport or absorption of the study drugs.
Cardiac function and disease are consistent with the following:
Active human immunodeficiency virus (HIV), syphilis, hepatitis c virus (HCV) or hepatitis b virus (HBV) infection, with the exception of asymptomatic chronic hepatitis b or hepatitis c carriers.
Previous history of interstitial lung disease(ILD) or drug-induced ILD or radiation pneumonitis require steroid treatment, or any evidence of clinically active ILD diseases.
Previous allogeneic bone marrow transplant.
Pregnant or lactating women.
Any other disease or medical condition that is unstable or may affect the safety or study compliance.
Hypersensitivity to TY-9591 or similar compounds or excipients.
Primary purpose
Allocation
Interventional model
Masking
420 participants in 2 patient groups
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Central trial contact
Yuankai Shi, MD
Data sourced from clinicaltrials.gov
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