Impact of Lazertinib Dose Modification on Effectiveness and Safety

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05716672
• Other study ID #: PNU-001
• Secondary ID: LASER IIT-018
• Status: Not yet recruiting
• Start date: February 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2023
• Source: Pusan National University Hospital
• Contact: Min Ki Lee, MD, PhD
• Phone: +82-51-240-7216
• Email: leemk[@]pusan.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Lazertinib
Lazertinib 240mg(3tablets, 80mg/1tablet), once a day(QD), oral(PO), until disease progression or unacceptable toxicity

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (2)

Lead Sponsor	Collaborator
Pusan National University Hospital	Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to approximately 3 years
Secondary	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.	Up to approximately 3 years
Secondary	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.	Up to approximately 3 years
Secondary	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.	Up to approximately 3 years
Secondary	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.	Up to approximately 3 years
Secondary	Overall Survival (OS)	Overall Survival (OS) is defined as the period from the start of Lazertinib administration to death from any cause.	Up to approximately 3 years