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

Metastatic Lung Non-Small Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05377788
• Other study ID #: KCSG LU22-01
• Status: Not yet recruiting
• Start date: July 31, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2022
• Source: Samsung Medical Center
• Contact: Shinkyo Yoon, MD
• Phone: +82-10-7232-2502
• Email: shinkyoyoon[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

• 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 900
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• EGFR T790M
• Metastatic Lung Non-Small Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Ahn MJ, Han JY, Lee KH, Kim SW, Kim DW, Lee YG, Cho EK, Kim JH, Lee GW, Lee JS, Min YJ, Kim JS, Lee SS, Kim HR, Hong MH, Ahn JS, Sun JM, Kim HT, Lee DH, Kim S, Cho BC. 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. Lancet Oncol. 2019 Dec;20(12):1681-1690. doi: 10.1016/S1470-2045(19)30504-2. Epub 2019 Oct 3. Erratum in: Lancet Oncol. 2020 Feb;21(2):e70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Overall survival (OS)	Overall survival (OS) is defined as the time from treatment to death.	Through study completion, an average of 3 years
Secondary	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
Secondary	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
Secondary	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