Complete surgical resection is the standard treatment in early-stage lung cancer. However, the patients with early resected Epidermal Growth Factor Receptor(EGFR)-mutated lung cancers have high recurrence rate. The efficacy of neoadjuvant treatment by first-generation EGFR-Tyrosine Kinase Inhibitor(TKI) has been demonstrated, however, that of the third-generation EGFR-TKI(lazertinib) has not yet been fully investigated. The aim of this study is to evaluate the efficacy of neoadjuvant Lazertinib in resectable EGFR mutation-positive NSCLC and clinical application of extracellular vesicles(EVs) based BALF liquid biopsy to identify EGFR mutation without invasive tissue biopsy.
The neoadjuvant treatment of 3rd-generation EGFR-TKI, lazertinib for 9 weeks before surgery is administrated. After the surgery, the patients with the tumor over stage 2 are given the lazertinib to prevent recurrence for 3 years or until recurrence. In early lung cancer, a tissue biopsy is often difficult due to the small size or the risky location. We collect bronchoalveolar lavage fluid for liquid biopsy and lazertinib is administrated according to the result of BALF liquid EGFR genotyping.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Lazertinib 240mg p.o once daily.
Konkuk University Medical Center
Seoul, South Korea
RECRUITINGObjective response rate
The objective response rate (ORR) evaluated with RECIST version 1.1. It is defined as the proportion of patients with complete response (CR) or partial response (PR) after 9 weeks of lazertinib administration
Time frame: 9 weeks after the starting day of the lazertinib
Down-staging rate
The rate of downstage by pathology stage compared with clinical stage
Time frame: From the day of screening to an average of 16 weeks after the first dose
Major pathological response
The proportion of patients with less than 10% of the cancer cells in the surgical sample.
Time frame: From the day of screening to an average of 16 weeks after the first dose
Disease-free survival rate
The length of time after surgical resection the patient remains free of recurrence/progression or death, whatever the cause.
Time frame: up to 3 years after surgery
The concordance rate of EGFR mutations between surgical tissue and BAL fluid samples
The concordance rate of BALF EGFR mutation compared with EGFR mutation status of surgical resected tissue
Time frame: From the day of screening day to an average of 16 weeks after the first dose
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