Impact of Lazertinib Dose Modification on Effectiveness and Safety

NCT05716672 | Unknown

• 2 other identifiers: PNU-001LASER IIT-018
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 11

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. 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. 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. 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. 4.To evaluate the treatment profile of Lazertinib including duration of treatment, dose adjustment, and reason for discontinuation of treatment.
5. 5.To evaluate the safety of Lazertinib in the 240 mg and 160 mg groups

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC; EGFR-TKI; Lazertinib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time-to-Treatment Discontinuation (TTD)

  Up to approximately 3 years

• Objective Response Rate(ORR)

  Up to approximately 3 years

• Disease Control Rate (DCR)

  Up to approximately 3 years

• Tumor shrinkage

  Up to approximately 3 years

• Overall Survival (OS)

  Up to approximately 3 years

Study Arms (2)

240mg group

Maintenance of the 240mg dose for 12 weeks after the first administration of Lazertinib

Drug: Lazertinib

160mg group

Reduction of the 160mg dose for 12 weeks after the first administration of Lazertinib

Drug: Lazertinib

Interventions

Lazertinib DRUG

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

Also known as: LECLAZA

160mg group; 240mg group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pusan National University Hospital: lead
• Yuhan Corporation: collaborator

Study Sites (11)

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Kosin University Gospel Hospital

Busan, 49267, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 42601, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

lazertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Min Ki Lee, MD, PhD

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Ki Lee, MD, PhD

CONTACT

+82-51-240-7216; leemk@pusan.ac.kr

Jung Seop Eom, MD, PhD

CONTACT

+82-51-240-7889; ejspulm@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: February 8, 2023
• Study Start: February 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (11)