Impact of Lazertinib Dose Modification on Effectiveness and Safety

January 29, 2023 updated by: Min Ki Lee, Pusan National University Hospital

Impact of Lazertinib Dose Modification on Effectiveness and Safety in EGFR T790M-Positive Advanced Lung Cancer

The primary objective is to evaluate Progression Free Survival (PFS) of the group (160 mg group) in which dose reduction was performed for 12 weeks after the first administration of Lazertinib.

The Secondary objectives of this study are as follows.

  1. To evaluate Progression-free survival (PFS) of the group maintaining the same dose (240mg group) and the group in which dose reduction was performed (160mg group) for 12 weeks after the first administration of Lazertinib
  2. In the group maintaining the same dose (240mg group) and the group in which dose reduction was performed (160mg group) for 12 weeks after the first administration of Lazertinib, Time-to-Treatment Discontinuation(TTD), Objective Response Rate(ORR), Disease Control Rate(DCR), Tumor shrinkage and Overall Survival(OS) is evaluated.
  3. In the group maintaining the same dose (240mg group) and the group in which dose reduction was performed (160mg group) for 12 weeks after the first administration of Lazertinib, specific reasons (adverse event name, grade, etc.) according to Lazertinib dose adjustment is evaluated.
  4. To evaluate the treatment profile of Lazertinib including duration of treatment, dose adjustment, and reason for discontinuation of treatment.
  5. To evaluate the safety of Lazertinib in the 240 mg and 160 mg groups

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a prospective multi-center observational study, and 11 institutions will participate to enroll 200 subjects competitively. We will evaluate the efficacy and safety of Lazertinib according to maintenance of the 240mg dose and reduction of the 160mg dose for 12 weeks after the first administration of Lazertinib in non-small cell lung cancer patients confirmed to be T790M mutation-positive after treatment failure with first- or second-generation EGFR-TKIs. The study period is up to 3 years from the date of IRB approval. Follow-up is 2 years from the last subject enrollment, and data will be collected through periodic medical record review during Lazertinib administration for enrolled subjects.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Jung Seop Eom, MD, PhD
  • Phone Number: +82-51-240-7889
  • Email: ejspulm@gmail.com

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
        • Contact:
        • Contact:
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital
        • Contact:
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital
        • Contact:
      • Busan, Korea, Republic of, 47392
        • Inje University Busan Paik Hospital
        • Contact:
      • Busan, Korea, Republic of, 49267
        • Kosin University Gospel Hospital
        • Contact:
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital
        • Contact:
      • Daegu, Korea, Republic of, 42415
        • Yeungnam University Medical Center
        • Contact:
      • Daegu, Korea, Republic of, 41944
        • Kyungpook National University Hospital
        • Contact:
          • Ji Eun Park, MD, PhD
          • Phone Number: +82-53-200-5505
          • Email: jieun@knu.ac.kr
      • Daegu, Korea, Republic of, 42472
        • Daegu Catholic University Medical Center
        • Contact:
      • Daegu, Korea, Republic of, 42601
        • Keimyung University Dongsan Medical Center
        • Contact:
      • Yangsan, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who agreed to participate in this study among patients scheduled to receive Lazertinib after T790M mutation was confirmed positive after treatment with 1st or 2nd generation EGFR-TKIs

Description

Inclusion Criteria:

  1. Patients who agreed in writing to participate in this study
  2. Adult men and women over 20 years of age
  3. Patients with locally advanced or metastatic, recurrent non-small cell lung cancer with EGFR mutation (based on AJCC 8th edition)
  4. Patients with confirmed disease progression after 1st or 2nd generation EGFR-TKI treatment
  5. Patients scheduled to receive Lazertinib after T790M mutation was confirmed positive in tissue or plasma

Exclusion Criteria:

  1. Patients who are receiving or have already completed Lazertinib
  2. Patients whose life expectancy is less than 12 weeks

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
240mg group
Maintenance of the 240mg dose for 12 weeks after the first administration of Lazertinib
Drug: Lazertinib
Lazertinib 240mg(3tablets, 80mg/1tablet), once a day(QD), oral(PO), until disease progression or unacceptable toxicity
Other Names:
  • LECLAZA
160mg group
Reduction of the 160mg dose for 12 weeks after the first administration of Lazertinib
Drug: Lazertinib
Lazertinib 240mg(3tablets, 80mg/1tablet), once a day(QD), oral(PO), until disease progression or unacceptable toxicity
Other Names:
  • LECLAZA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival(PFS)
Time Frame: Up to approximately 3 years
Progression-free survival is defined as the period from the start of Lazertinib administration to the time when objective disease progression is confirmed or death from any cause during treatment, whichever occurs first.
Up to approximately 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time-to-Treatment Discontinuation (TTD)
Time Frame: Up to approximately 3 years
Time-to-Treatment Discontinuation (TTD) is defined as the time from the start of Lazertinib administration to the point at which Lazertinib administration was discontinued for any reason.
Up to approximately 3 years
Objective Response Rate(ORR)
Time Frame: Up to approximately 3 years
Objective Response Rate (ORR) is defined as the proportion of subjects whose best overall response was complete response(CR) or partial response(PR) during the period of Lazertinib administration.
Up to approximately 3 years
Disease Control Rate (DCR)
Time Frame: Up to approximately 3 years
Disease Control Rate (DCR) is defined as the proportion of subjects whose best overall response was complete response(CR), partial response(PR), or stable disease(SD) during the period of Lazertinib administration.
Up to approximately 3 years
Tumor shrinkage
Time Frame: Up to approximately 3 years
Tumor shrinkage is defined as the ratio of the size of the primary lesion at the time of baseline before the first administration of Lazertinib and the size of the primary lesion at the time of maximum overall response during Lazertinib administration.
Up to approximately 3 years
Overall Survival (OS)
Time Frame: Up to approximately 3 years
Overall Survival (OS) is defined as the period from the start of Lazertinib administration to death from any cause.
Up to approximately 3 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pusan National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Yuhan Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Min Ki Lee, MD, PhD, Pusan National University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2023

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PNU-001
  • LASER IIT-018 (OTHER_GRANT: Yuhan Corporation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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