Impact of Lazertinib Dose Modification on Effectiveness and Safety

• Sponsor: Pusan National University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05716672
• Collaborator: Yuhan Corporation (Industry)
• Enrollment: 200
• Locations: 11
• Anticipated Duration (Months): 35
• Patients Per Site: 18.2
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: Lazertinib

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

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Impact of Lazertinib Dose Modification on Effectiveness and Safety in EGFR T790M-Positive Advanced Lung Cancer
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival(PFS) [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.

Secondary Outcome Measures

1. Time-to-Treatment Discontinuation (TTD) [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.

2. Objective Response Rate(ORR) [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.

3. Disease Control Rate (DCR) [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.

4. Tumor shrinkage [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.

5. Overall Survival (OS) [Up to approximately 3 years]

   Overall Survival (OS) is defined as the period from the start of Lazertinib administration to death from any cause.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inje University Busan Paik Hospital	Busan		Korea, Republic of	47392
2	Inje University Haeundae Paik Hospital	Busan		Korea, Republic of	48108
3	Dong-A University Hospital	Busan		Korea, Republic of	49201
4	Pusan National University Hospital	Busan		Korea, Republic of	49241
5	Kosin University Gospel Hospital	Busan		Korea, Republic of	49267
6	Kyungpook National University Chilgok Hospital	Daegu		Korea, Republic of	41404
7	Kyungpook National University Hospital	Daegu		Korea, Republic of	41944
8	Yeungnam University Medical Center	Daegu		Korea, Republic of	42415
9	Daegu Catholic University Medical Center	Daegu		Korea, Republic of	42472
10	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of	42601
11	Pusan National University Yangsan Hospital	Yangsan		Korea, Republic of	50612

Sponsors and Collaborators

• Pusan National University Hospital
• Yuhan Corporation

Investigators

• Principal Investigator: Min Ki Lee, MD, PhD, Pusan National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Min Ki Lee, Professor, Pusan National University Hospital
• ClinicalTrials.gov Identifier: NCT05716672
• Other Study ID Numbers: PNU-001; LASER IIT-018
• First Posted: Feb 8, 2023
• Last Update Posted: Feb 8, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Min Ki Lee, Professor, Pusan National University Hospital: NSCLC; EGFR-TKI; Lazertinib
• Additional relevant MeSH terms: Lung Neoplasms; Lazertinib

Study Results

No Results Posted as of Feb 8, 2023