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It is to evaluate the safety and effectiveness of a lasertinib(LECLAZA) single drug in a actual medical environment for patients
Primary Purpose: Progression-free survival (PFS)
Secondary Purpose:
Research Design : a Multi-Center Prospective and Restrospective Cohort Study
â–¡ 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.
â–¡ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective cohort |
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| |
| Restrospective cohort |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 |
| 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) |
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Inclusion Criteria:
Prospective cohort
Rectrospective cohort
Exclusion Criteria:
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Retrospective cohort: 300 people Prospective cohort: 600 people
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shinkyo Yoon, MD | Contact | +82-10-7232-2502 | shinkyoyoon@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Jin Seok Ahn, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 06351 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000707992 | lazertinib |
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â–¡Plasma Circulatory Tumor DNA Collection Blood: Before First Dose(laziertinib), End of Treatment(lazertinib) - Total 20ml (10ml*2 times)
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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 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |