Lazertinib 160mg in EGFR T790M NSCLC

January 26, 2023 updated by: Jong-Mu Sun, Samsung Medical Center

A Phase II Study for the Evaluation of the Feasibility of Lazertinib 160mg Per Day in Patients With EGFR T790M Mutant Non-small Cell Lung Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

117

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lazertinib 160mg arm
Drug: Lazertinib
160mg po qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The dose reduction or treatment discontinuation rate
Time Frame: Total 24 months of study period
Dose who received dosage below 160mg or discontinued due to the adverse event
Total 24 months of study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

January 31, 2024

Study Completion (Anticipated)

January 31, 2025

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC 2023-01-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The only clinical outcome data will be published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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