NCT05701384

Brief Summary

The lazertinib is currently approved as 2nd line T790M mutation-positive NSCLC that failed from either 1st or 2nd generation EGFR TKI. The current recommended dosage is 240mg. Based on the promising clinical efficacy of the dose escalation study, this study is designed to evaluatee the clinical efficacy and safety of 160mg lazertinib.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
117

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

January 17, 2023

Last Update Submit

January 26, 2023

Conditions

Lung Cancer Stage IVEGFR T790M

Outcome Measures

Primary Outcomes (1)

  • The dose reduction or treatment discontinuation rate

    Dose who received dosage below 160mg or discontinued due to the adverse event

    Total 24 months of study period

Study Arms (1)

Lazertinib 160mg arm

EXPERIMENTAL
Drug: Lazertinib

Interventions

LazertinibDRUG

160mg po qd

Lazertinib 160mg arm

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed non-small cell lung cancer
  • Patients in a palliative setting who is not applicable for the curative treatment
  • EGFR mutation positive patients who received previous 1st or 2nd generation EGFR TKI
  • Confirmed EGFR T790M mutation after the previous EGFR TKI
  • Available to receive lazertinib either as po or vis levine tube
  • Willing to participate clinical trial
  • Age over or equal to 19
  • ECOG PS 0 to 2

You may not qualify if:

  • Previously received 3rd generation EGFR TKI
  • No clinical benefit is expected based on the investigator's decision
  • Uncontrolled symptomatic CNS metastases
  • Uncontrolled systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, MA, 06351, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

lazertinib

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 17, 2023

First Posted

January 27, 2023

Study Start

February 1, 2023

Primary Completion

January 31, 2024

Study Completion

January 31, 2025

Last Updated

January 27, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

The only clinical outcome data will be published

Locations

KR(1)