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

NCT05377788 | Unknown DMC

• 1 other identifier: KCSG LU22-01
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

• 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

Conditions

Metastatic Lung Non-Small Cell Carcinoma; EGFR T790M

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Objective response rate (ORR)

  Through study completion, an average of 3 years

• Time to treatment failure (TTF)

  Through study completion, an average of 3 years

• Overall survival (OS)

  Through study completion, an average of 3 years

• Duration of response (DoR)

  Through study completion, an average of 3 years

• Intracranial Progression-free survival (Intracranial PFS)

  Through study completion, an average of 3 years

Study Arms (2)

Prospective cohort

* Inclusion criteria * 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 * 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

Restrospective cohort

* Inclusion criteria * adults over the age of 19 * Patients 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

Interventions

Lazertinib DRUG

Treatment of EGFR T790M mutant-positive local progressive or metastatic non-small cell lung cancer patients who have previously been treated with EGFR

Also known as: LECLAZA

Prospective cohort; Restrospective cohort

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Retrospective cohort: 300 people Prospective cohort: 600 people

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related 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.

  PMID: 31587882 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

□Plasma Circulatory Tumor DNA Collection Blood: Before First Dose(laziertinib), End of Treatment(lazertinib) - Total 20ml (10ml\*2 times)

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

• Jin Seok Ahn, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shinkyo Yoon, MD

CONTACT

+82-10-7232-2502; shinkyoyoon@amc.seoul.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 17, 2022
• Study Start: July 31, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)