Clinical trial NCT05377788: Lazertinib Real-world Observational Study of in Pre-treated EGFR T790M Mutant With Advanced Non-small Cell Lung Cancer
Official title: Lazertinib Real-world Observational Study of in Pre-treated EGFR T790M Mutant With Advanced Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Lung Non-Small Cell Carcinoma
EGFR T790M
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 900
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective cohort: 300 people Prospective cohort: 600 people

Brief 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Through study completion, an average of 3 years
measure: Time to treatment failure (TTF)
timeFrame: Through study completion, an average of 3 years
measure: Overall survival (OS)
timeFrame: Through study completion, an average of 3 years
measure: Duration of response (DoR)
timeFrame: Through study completion, an average of 3 years
measure: Intracranial Progression-free survival (Intracranial PFS)
timeFrame: Through study completion, an average of 3 years
measure: Relative dose intensity
timeFrame: Through study completion, an average of 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jin Seok Ahn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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