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

NCT03046992 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2025-03-21

No results posted yet for this study

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.

Conditions

  • EGFR Gene Mutation

Interventions

DRUG

YH25448

* Dose Escalation: YH25448 20mg\~320mg, PO * Dose Expansion: YH25448 40mg\~240mg, PO * Dose Extension: Recommended Dose 240mg of YH25448

Sponsors & Collaborators

  • Yuhan Corporation

    lead INDUSTRY

Principal Investigators

  • Yuhan Corporation · Clinical Development Department

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2021-01-08
Completion
2023-03-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03046992 on ClinicalTrials.gov