Trial Title:
Impact of Lazertinib Dose Modification on Effectiveness and Safety
NCT ID:
NCT05716672
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Lazertinib
Conditions: Keywords:
NSCLC
EGFR-TKI
Lazertinib
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Lazertinib
Description:
Lazertinib 240mg(3tablets, 80mg/1tablet), once a day(QD), oral(PO), until disease
progression or unacceptable toxicity
Arm group label:
160mg group
Arm group label:
240mg group
Other name:
LECLAZA
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. 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
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Inje University Busan Paik Hospital
Address:
City:
Busan
Zip:
47392
Country:
Korea, Republic of
Contact:
Last name:
Hyun-kyung Lee, MD, PhD
Phone:
+82-51-890-6243
Email:
goodoc@gmail.com
Facility:
Name:
Inje University Haeundae Paik Hospital
Address:
City:
Busan
Zip:
48108
Country:
Korea, Republic of
Contact:
Last name:
Jin-han Park, MD, PhD
Phone:
+82-51-240-2211
Email:
h00389@paik.ac.kr
Facility:
Name:
Dong-A University Hospital
Address:
City:
Busan
Zip:
49201
Country:
Korea, Republic of
Contact:
Last name:
Insu Kim, MD, PhD
Phone:
+82-51-240-5597
Email:
wisedoc08@gmail.com
Facility:
Name:
Pusan National University Hospital
Address:
City:
Busan
Zip:
49241
Country:
Korea, Republic of
Contact:
Last name:
Min Ki Lee, MD, PhD
Phone:
+82-51-240-7216
Email:
leemk@pusan.ac.kr
Contact backup:
Last name:
Jung Seop Eom, MD, PhD
Phone:
+82-51-240-7889
Email:
ejspulm@gmail.com
Facility:
Name:
Kosin University Gospel Hospital
Address:
City:
Busan
Zip:
49267
Country:
Korea, Republic of
Contact:
Last name:
Tae Won Jang, MD, PhD
Phone:
+82-51-990-6637
Email:
jangtw22@hanmail.net
Facility:
Name:
Kyungpook National University Chilgok Hospital
Address:
City:
Daegu
Zip:
41404
Country:
Korea, Republic of
Contact:
Last name:
Sun Ha Choi, MD, PhD
Phone:
+82-53-200-3091
Email:
sunha20@gmail.com
Facility:
Name:
Kyungpook National University Hospital
Address:
City:
Daegu
Zip:
41944
Country:
Korea, Republic of
Contact:
Last name:
Ji Eun Park, MD, PhD
Phone:
+82-53-200-5505
Email:
jieun@knu.ac.kr
Facility:
Name:
Yeungnam University Medical Center
Address:
City:
Daegu
Zip:
42415
Country:
Korea, Republic of
Contact:
Last name:
June Hong Ahn, MD, PhD
Phone:
+82-53-640-6577
Email:
fireajh@gmail.com
Facility:
Name:
Daegu Catholic University Medical Center
Address:
City:
Daegu
Zip:
42472
Country:
Korea, Republic of
Contact:
Last name:
Chi-Young Jung, MD, PhD
Phone:
+82-53-650-3263
Email:
jcy2475@cu.ac.kr
Facility:
Name:
Keimyung University Dongsan Medical Center
Address:
City:
Daegu
Zip:
42601
Country:
Korea, Republic of
Contact:
Last name:
Sun Hyo Park, MD, PhD
Phone:
+82-53-258-7737
Email:
ibagu70@hanmail.net
Facility:
Name:
Pusan National University Yangsan Hospital
Address:
City:
Yangsan
Zip:
50612
Country:
Korea, Republic of
Contact:
Last name:
Seong Hoon Yoon, MD, PhD
Phone:
+82-55-360-1415
Email:
drysh79@gmail.com
Start date:
February 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Pusan National University Hospital
Agency class:
Other
Collaborator:
Agency:
Yuhan Corporation
Agency class:
Industry
Source:
Pusan National University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05716672
