RecruitingPhase 2

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

China420 participantsStarted 2023-08-17

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female aged ≥18 years and \<80 years.
. Patients diagnosed with NSCLC by histology or cytology, with brain metastases.
. 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).
. No prior systemic antitumor therapy for locally advanced or metastatic NSCLC.
. Stable brain metastases that do not require immediate or planned local treatment for it during the study period.
. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
. 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.
. Adequate bone marrow reserve function, and no liver, kidney and coagulation dysfunction.

Exclusion criteria

. Any of the following treatment:
. Previous treatment with EGFR inhibitor;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Intracranial Overall Response Rate (iORR)

Timeframe: 36 months

Intracranial Median Progression Free Survival (iPFS)

Timeframe: 36 months

Trial details

NCT IDNCT05948813

SponsorTYK Medicines, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-30

Contact for this trial

Yuankai Shi, MD

+86-10-87788293 syuankaipum@126.com

View on ClinicalTrials.gov More NSCLC trials