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.
Age ≥ 19 years
Patients with suspected lung cancer on chest CT findings
Patients with the following EGFR gene mutations in the test on bronchoalveolar lavage fluid: E19Del, L858R alone or concurrent rare EGFR gene mutations (T790M, G719X, exon 20 insertion, S768I)
Patients whose tumor can be completely resected by surgery: patients with stage I-IIIB, or stage IVA who has single metastasis
Uncontrolled active interstitial lung disease
Pathologically confirmed N3 disease
Uncontrolled stage III-IV other malignancy
Uncontrolled Hypertension, Congestive Heart failure with New York Heart Association(NYHA) ≥ 3, acute myocardial infarct history within 6 months before screening. 2nd- 3rd Atrio-Ventricular(AV) block or complete AV block
Single group
Neoadjuvant lazertinib
DrugLazertinib 240mg p.o once daily.
Objective 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
Down-staging rate
The rate of downstage by pathology stage compared with clinical stage
Major pathological response
The proportion of patients with less than 10% of the cancer cells in the surgical sample.
Disease-free survival rate
The length of time after surgical resection the patient remains free of recurrence/progression or death, whatever the cause.
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
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Konkuk University Medical Center
Lead sponsor
Yuhan Corporation
Collaborator
