Clinical Trial of YH25448 in Patients with EGFR Mutation Positive Advanced NSCLC (NCT03046992) | Clinical Trial Compass
CompletedPhase 1/2
Clinical Trial of YH25448 in Patients with EGFR Mutation Positive Advanced NSCLC
South Korea224 participantsStarted 2017-02-15
Plain-language summary
YH25448 is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase inhibitors (TKIs) targets both the T790M mutation and activating EGFR mutations while sparing wild type-EGFR. YH25448 is expected to beneficial for the NSCLC patients with brain metastasis due to good blood brain barrier (BBB) penetration property as well as for the treatment of primary lung lesion and extracranial lesions. This study will be conducted to evaluate the safety, tolerability and efficacy of YH25448 in locally advanced or metastatic NSCLC patients with EGFR mutations.
Who can participate
Age range
20 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:
* Histologically or cytologically confirmed diagnosis of NSCLC with single activating EGFR mutations.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 3 months.
* At least one measurable extracranial lesion, not previously irradiated and not chosen biopsy during the study screening period.
* Prior to enrolling in the study, patients must have central confirmation of T790M+ mutation status from a sample taken after documented progression on the EGFR-TKIs therapy according to cohort.
Exclusion Criteria:
* Spinal cord compression.
* Brain metastases with symptomatic and/or requiring steroid for at least 2 weeks prior to start of study treatment.
* Known intracranial hemorrhage which is unrelated to tumor.
* Central Nervous System (CNS) complications that require urgent neurosurgical intervention (e.g. resection or shunt placement).
* Leptomeningeal metastasis prior to study treatment.
* Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
* Any cardiovascular disease as followed.
* History of symptomatic congestive heart failure (CHF) or serious cardiac arrhythmia requiring treatment
* History of myocardial infarction or unstable angina within 6 months of the first dose of study treatment
* Left ventricular ejection fraction (LVEF)…
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
1
Safety and tolerability by Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Timeframe: Safety and tolerability profile will be collected from baseline until 28 days after the last dose, expected average 1 year.
2
Objective Response Rate (ORR)
Timeframe: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.