Spots Global Cancer Trial Database for TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases

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Trial Identification

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

Official Title: A Phase II Study of TY-9591 Tablets in Patients With EGFR-Mutated Non-small Cell Lung Cancer With Brain Metastases

Study ID: NCT05948813

Conditions

NSCLC

EGFR Activating Mutation

Brain Metastases

Interventions

TY-9591

Osimertinib

Study Description

Brief 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).