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

Plain-language summary

This study examines the drug YH25448 in patients with EGFR mutation positive advanced non-small cell lung cancer (NSCLC). It enrolled patients whose disease had progressed after EGFR-TKI therapy and had a confirmed T790M mutation. The study was carried out in Phase 1/Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

PHASE1/PHASE2

Status

Completed

Sponsor

Yuhan Corporation

Intervention

YH25448

Start date

2/15/2017

Estimated completion

3/30/2023

Countries

South Korea

Related genes

Locations

• Bucheon-si, South Korea
• Goyang-si, South Korea
• Seongnam-si, South Korea
• Seongnam-si, South Korea
• Suwon, South Korea
• Jinju, South Korea
• Cheongju-si, South Korea
• Busan, South Korea
• Incheon, South Korea
• Seoul, South Korea
• Seoul, South Korea
• Seoul, South Korea
• Seoul, South Korea
• Seoul, South Korea
• Seoul, South Korea
• Ulsan, South Korea

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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) \< 50%