Non-small Cell Lung CancerNCT05716672
Impact of Lazertinib Dose Modification on Effectiveness and Safety
An observational study of Non-small Cell Lung Cancer, run by Pusan National University Hospital at 11 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Lazertinib
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 11 sitesSouth Korea
- Study dates
- 1 Feb 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients who agreed in writing to participate in this study
- Adult men and women over 20 years of age
- Patients with locally advanced or metastatic, recurrent non-small cell lung cancer with EGFR mutation (based on AJCC 8th edition)
- Patients with confirmed disease progression after 1st or 2nd generation EGFR-TKI treatment
- Patients scheduled to receive Lazertinib after T790M mutation was confirmed positive in tissue or plasma
Who cannot join
- Patients who are receiving or have already completed Lazertinib
- Patients whose life expectancy is less than 12 weeks
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Inje University Busan Paik Hospital
Busan, 47392
Hyun-kyung Lee, MD, PhD, +82-51-890-6243, goodoc@gmail.com
Inje University Haeundae Paik Hospital
Busan, 48108
Jin-han Park, MD, PhD, +82-51-240-2211, h00389@paik.ac.kr
Dong-A University Hospital
Busan, 49201
Insu Kim, MD, PhD, +82-51-240-5597, wisedoc08@gmail.com
Pusan National University Hospital
Busan, 49241
Min Ki Lee, MD, PhD, +82-51-240-7216, leemk@pusan.ac.kr
Jung Seop Eom, MD, PhD, +82-51-240-7889, ejspulm@gmail.com
Kosin University Gospel Hospital
Busan, 49267
Tae Won Jang, MD, PhD, +82-51-990-6637, jangtw22@hanmail.net
Kyungpook National University Chilgok Hospital
Daegu, 41404
Sun Ha Choi, MD, PhD, +82-53-200-3091, sunha20@gmail.com
Kyungpook National University Hospital
Daegu, 41944
Ji Eun Park, MD, PhD, +82-53-200-5505, jieun@knu.ac.kr
Yeungnam University Medical Center
Daegu, 42415
June Hong Ahn, MD, PhD, +82-53-640-6577, fireajh@gmail.com
Daegu Catholic University Medical Center
Daegu, 42472
Chi-Young Jung, MD, PhD, +82-53-650-3263, jcy2475@cu.ac.kr
Keimyung University Dongsan Medical Center
Daegu, 42601
Sun Hyo Park, MD, PhD, +82-53-258-7737, ibagu70@hanmail.net
Pusan National University Yangsan Hospital
Yangsan, 50612
Seong Hoon Yoon, MD, PhD, +82-55-360-1415, drysh79@gmail.com
About this study
Official title: 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.
- 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
- 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.
- 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.
- To evaluate the treatment profile of Lazertinib including duration of treatment, dose adjustment, and reason for discontinuation of treatment.
- To evaluate the safety of Lazertinib in the 240 mg and 160 mg groups
Read the 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Lazertinib
- Keywords
- NSCLC, EGFR-TKI, Lazertinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LazertinibDrug
Also called LECLAZA
Lazertinib 240mg(3tablets, 80mg/1tablet), once a day(QD), oral(PO), until disease progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| 240mg group | Maintenance of the 240mg dose for 12 weeks after the first administration of Lazertinib Receives: Drug: Lazertinib | |
| 160mg group | Reduction of the 160mg dose for 12 weeks after the first administration of Lazertinib Receives: Drug: Lazertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival(PFS)
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.
Measured: Up to approximately 3 years
Secondary outcomes (5)
Time-to-Treatment Discontinuation (TTD)
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.
Measured: Up to approximately 3 years
Objective Response Rate(ORR)
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.
Measured: Up to approximately 3 years
Disease Control Rate (DCR)
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.
Measured: Up to approximately 3 years
Tumor shrinkage
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.
Measured: Up to approximately 3 years
Overall Survival (OS)
Overall Survival (OS) is defined as the period from the start of Lazertinib administration to death from any cause.
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Feb 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yuhan Corporation
- Responsible party
- Principal investigator, Min Ki Lee, Pusan National University Hospital
- Investigators
- Min Ki Lee, MD, PhD, Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716672
- Sponsor's protocol ID
- PNU-001
- Other IDs
- LASER IIT-018
- Status last verified
- Jan 2023
- First submitted
- 29 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lazertinib Dose Modification on Effectiveness and Safety in EGFR T790M-Positive Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT05716672
- Acronym / sponsor ID
- PNU-001
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NSCLC, EGFR-TKI, Lazertinib
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Collaborators
- Yuhan Corporation
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
- 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.
- 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.
- To evaluate the treatment profile of Lazertinib including duration of treatment, dose adjustment, and reason for discontinuation of treatment.
- To evaluate the safety of Lazertinib in the 240 mg and 160 mg groups
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 240mg group | – | Drug: LazertinibMaintenance of the 240mg dose for 12 weeks after the first administration of Lazertinib |
| 160mg group | – | Drug: LazertinibReduction of the 160mg dose for 12 weeks after the first administration of Lazertinib |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- Patients who agreed in writing to participate in this study
- Adult men and women over 20 years of age
- Patients with locally advanced or metastatic, recurrent non-small cell lung cancer with EGFR mutation (based on AJCC 8th edition)
- Patients with confirmed disease progression after 1st or 2nd generation EGFR-TKI treatment
- Patients scheduled to receive Lazertinib after T790M mutation was confirmed positive in tissue or plasma
Key exclusion criteria (2 listed)
- Patients who are receiving or have already completed Lazertinib
- Patients whose life expectancy is less than 12 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LazertinibAlso: LECLAZALazertinib 240mg(3tablets, 80mg/1tablet), once a day(QD), oral(PO), until disease progression or unacceptable toxicity | Drug | 160mg group, 240mg group |
Primary outcome
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.
5 secondary outcomes
Time-to-Treatment Discontinuation (TTD)
Time frame: Up to approximately 3 years
Objective Response Rate(ORR)
Time frame: Up to approximately 3 years
Disease Control Rate (DCR)
Time frame: Up to approximately 3 years
Tumor shrinkage
Time frame: Up to approximately 3 years
Overall Survival (OS)
Time frame: Up to approximately 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Ki Lee, MD, PhD principal investigator
Pusan National University Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Pusan National University Hospital at 11 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Ki Lee, MD, PhD (+82-51-240-7216, leemk@pusan.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival(PFS) (time frame: Up to approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.