Lazertinib Real-world Observational Study of in Pre-treated EGFR T790M Mutant With Advanced Non-small Cell Lung Cancer

• It is to evaluate the safety and effectiveness of a lasertinib(LECLAZA) single drug in a actual medical environment for patients

  1. Primary Purpose: Progression-free survival (PFS)

  2. Secondary Purpose:

     • Objective response rate
     • Time to treatment failure
     • Adverse event (AE), serious adverse event (SAE), and adverse event of special interest (AESI)
     • Severity of (S)AE
     • duration of response (DoR)
     • Overall survival (OS)
     • Intravenous Progressive Survival Period (Intracranial PFS)
     • Relative dose intensity
• Research Design : a Multi-Center Prospective and Restrospective Cohort Study

Study Overview

• Status: Not yet recruiting
• Conditions: Metastatic Lung Non-Small Cell Carcinoma; EGFR T790M
• Intervention / Treatment: Drug: Lazertinib

Detailed Description

□ the purpose of the study The study aims to explore the safety, efficacy and resistance of test drugs in patients with local progressive or metastatic epithelial growth factor T790M mutant non-small cell lung cancer who have been treated with epithelial growth factor receptor tyrosine kinase inhibitors.

This study is conducted in Korea. About 600 patients will be monitored until the first occurrence of disease progression, withdrawal of consent, failure of follow-up investigation, and death.

□ Research Procedures and Information Gathering Items There are no additional procedures performed by participating in this study and information on safety and effectiveness during the administration of Rexhraza will be followed up in routine care situations.

The information you will receive when you participate in this study is as follows.

• Subject characteristics, including age, gender, and race
• T790M Positive Mutation Status Results and Types of Tests Performed and Receptors
• a related medical history
• a physical examination
• disease characteristics
• history of chemotherapy
• associated concomitant medications
• administration of a test drug
• Safety and effectiveness
• Resistance mechanism in plasma circulation tumor DNA

• Study Type: Observational
• Enrollment (Anticipated): 900

Contacts and Locations

• Study Contact: Name: Shinkyo Yoon, MD; Phone Number: +82-10-7232-2502; Email: shinkyoyoon@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
    • Contact: Jin Seok Ahn, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Retrospective cohort: 300 people Prospective cohort: 600 people

Description

Inclusion Criteria:

1. Prospective cohort

   • adults over the age of 19
   • Easter Cooperative Oncology Group performance 0-4
   • Patients who are eligible for or are being treated for test medication as per permit: patients with NSCLC with local progressive or metastatic EGFR T790M mutation who have previously been treated with Generation 1 or Generation 2 EGFR TKI
   • EGFR T790M mutation allows for all results identified in tumor tissue or plasma
   • Patients with brain MR within 3 months of study participation

2. Rectrospective cohort

   • adults over the age of 19
   • Patients who are already using the test drug according to the domestic authorization of the test drug

Exclusion Criteria:

• Patients who have a history of hypersensitivity to test drugs or drugs of similar chemical structure or similar family to those of test drugs
• Pregnant women or lactating women
• Patients participating in other interventional clinical studies

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective cohort; Inclusion criteriaadults over the age of 19Easter Cooperative Oncology Group performance 0-4Patients who are eligible for or are being treated for test medication as per permit: patients with NSCLC with local progressive or metastatic EGFR T790M mutation who have previously been treated with Generation 1 or Generation 2 EGFR TKIEGFR T790M mutation allows for all results identified in tumor tissue or plasmaPatients with brain MR within 3 months of study participation; After obtaining a consent form for research participation, follow-up and monitoring survival information and safety information. Survival follow-up of prospective cohorts will be followed up to the point of first occurrence during disease progression, withdrawal of consent, failure of follow-up investigation, and death.	Drug: Lazertinib; Treatment of EGFR T790M mutant-positive local progressive or metastatic non-small cell lung cancer patients who have previously been treated with EGFR; Other Names: LECLAZA
Restrospective cohort; Inclusion criteriaadults over the age of 19Patients who are already using the lazertinib according to the domestic authorization of lazertinib(This includes when participants receive interventions as part of routine medical care); Survival information is monitored after the time when the consent form for participation in the study is obtained. Survival follow-up of retrospective cohorts will be followed up to the point of first occurrence during disease progression, withdrawal of consent, failure of follow-up investigation, and death	Drug: Lazertinib; Treatment of EGFR T790M mutant-positive local progressive or metastatic non-small cell lung cancer patients who have previously been treated with EGFR; Other Names: LECLAZA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	Progression-free survival (PFS) is defined as the time from study enrollment until objective disease progression or death.	Through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	Objective response rate is defined as the proportion of patients who have a partial or complete response to therapy.	Through study completion, an average of 3 years
Time to treatment failure (TTF)	Time to treatment failure (TTF) is defined as the interval between initiating therapy and the earliest of clinical progression, new locally directed or systemic treatment other than lazertinib.	Through study completion, an average of 3 years
Overall survival (OS)	Overall survival (OS) is defined as the time from treatment to death.	Through study completion, an average of 3 years
Duration of response (DoR)	Duration of response (DoR) is the length of time that a tumor continues to respond to treatment without cancer growing or spreading.	Through study completion, an average of 3 years
Intracranial Progression-free survival (Intracranial PFS)	Intracranial PFS is defined as the time from study enrollment until objective intracranial progression.	Through study completion, an average of 3 years
Relative dose intensity	Relative dose intensity is defined as the actual dose received divided by the standard calculated dose during a predefined period.	Through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Publications and helpful links

General Publications

• 1. Nguyen KS, Kobayashi S, Costa DB. Acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancers dependent on the epidermal growth factor receptor pathway. Clin Lung Cancer. 2009;10:281-9. 2. Dhillon S. Lazertinib: First Approval. Drugs. 2021;81:1107-13. 3. Ahn M-J, Han J-Y, Lee KH, Kim S-W, Kim D-W, Lee Y-G, et al. Lazertinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: results from the dose escalation and dose expansion parts of a first-in-human, open-label, multicentre, phase 1-2 study. The Lancet Oncology. 2019;20:1681-90. 4. Yun J, Hong MH, Kim SY, Park CW, Kim S, Yun MR, et al. YH25448, an Irreversible EGFR-TKI with Potent Intracranial Activity in EGFR Mutant Non-Small Cell Lung Cancer. Clin Cancer Res. 2019;25:2575-87

Study record dates

Study Major Dates

• Study Start (Anticipated): July 31, 2022
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Lazertinib
• Other Study ID Numbers: KCSG LU22-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No