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

Sponsor
TYK Medicines, Inc
Study ID
NCT05948813
Phase
PHASE2
Status
Recruiting
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Conditions

  • Brain Metastases
  • EGFR Activating Mutation
  • NSCLC

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • TY-9591 — DRUG
    The dose of TY-9591 tablet is 160 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment until meet the of discontinuation criteria.
  • Osimertinib — DRUG
    The dose of Osimertinib is 80 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment until meet the of discontinuation criteria.

Study Details

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.

Key Dates

Start date
Aug 17, 2023
Status verified
Jul 2024
Primary completion
Jun 30, 2025
Completion
Dec 30, 2027

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TY-9591 Tablets
    TY-9591 (160mg orally, once daily), in accordance with the randomization schedule.
  • Active Comparator: Osimertinib
    Osimertinib (80mg orally, once daily), in accordance with the randomization schedule.

Primary Outcome Measure

Intracranial Overall Response Rate (iORR) [ Time Frame: 36 months ]

Central Contacts

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