For Healthcare Professionals

Clinical Trial of YH25448 in Patients With EGFR Mutation Positive Advanced NSCLC

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Histologically or cytologically confirmed diagnosis of NSCLC with single activating EGFR mutations.
  2. 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.
  3. At least one measurable extracranial lesion, not previously irradiated and not chosen biopsy during the study screening period.
  4. 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

  1. Spinal cord compression.
  2. Brain metastases with symptomatic and/or requiring steroid for at least 2 weeks prior to start of study treatment.
  3. Known intracranial hemorrhage which is unrelated to tumor.
  4. Central Nervous System (CNS) complications that require urgent neurosurgical intervention (e.g. resection or shunt placement).
  5. Leptomeningeal metastasis prior to study treatment.
  6. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
  7. Any cardiovascular disease as followed.
  8. History of symptomatic congestive heart failure (CHF) or serious cardiac arrhythmia requiring treatment
  9. History of myocardial infarction or unstable angina within 6 months of the first dose of study treatment
  10. Left ventricular ejection fraction (LVEF) < 50%
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +82-2-828-0565Email iconEmail Study Center

Study’s details


Contition

EGFR Gene Mutation

Age

20+

Phase

Phase 1/Phase 2

Participants needed

230

Est. Completion Date

Dec 2022

Treatment type

Interventional


Sponsor

Yuhan Corporation

ClinicalTrials.gov identifier

NCT03046992

Study number

YH25448-201

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