None listed
Conditions
Interventions
Drug : Lazertinib 240mg taken orally once a day is administered for 9 weeks before a sugery to the patients with active EGFR mutations, Exon 19 deletion, or 21L858R or combined with rare EGFR mutation
Sponsors
Konkuk University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age =18 years 2) Suspected lung cancer on chest CT image 3) EGFR mutation positive in bronchoalveolarlavage fluid (E19Del, L858R single mutation or combined with rare mutataion(T790M, G719X, exon 20 insertion, S768I) 4) Complete resectable lung cancer (stage I-IIIB or Stage IVA single metastasis( more than 1cm ) 5) ECOG Perfromance status 0-1 6) No prior EGFR-TKI therapy 7) According to RECIST criteria, size more than 1 cm 8) Tolerable lung and cardiac function for surgery 9) The women of childbearing potential agree with using highly effective contraceptive methods (ex intrauterine loop, contraception pills) and must have a negative pregnancy test prior to start of dosing 10) Male patients must be willing to use barrier contraception during the trial period 11) Obtain the informed consent with signature, date and time before all procedures, sample collection and analysis 12) Adequate organ functions Hemoglobin = 9.0g/dL Absolut neutrophil count (ANC) = 1500/mm3 Platelet = 100,000 /mm3 Creatinine = Within normal limit * 1.5 Total bilirubin = 1.5 mg/dl AST/ALT/ALP = Within normal limit * 5 13) No clinical trial medications within 4 weeks
Exclusion criteria
Exclusion criteria: 1) Active or not controlled interstitial lung disease 2) Pathologically confirmed N3 3) Uncontrolled stage III-IV cancer of other organs 4) Uncontrolled hypertension, dyspnea more than NYHA=3, Myocardial infartion within 6 month, 2 or 3rd AV block. complete AV block 5) Uncontrolled Gestrointestinal disease which affect the absortion of drug 6) Active viral B hepatitis, active viral C hepatitis or HIV infection 7) Severe anaphylasix history for clinical trial drug ingredients 8) Positive pregnancy test prior to first dose of study drug; or breast-feeding woman. (Exception :The women of childbearing potential but have intrauterine loop can be enrolled) 9) The subjects who are unable to participate in the clinical trial, such as when they have poor compliance with requirements of the clinical trial protocol or follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathologic response;Down staging rate;Disease free survival rate (1 year, 2 year, 3year);Primary resistance rate ;Concordance rate of BAL liqud and tissue EGFR mutation | — |
Countries
Korea, Republic of
Contacts
Public ContactIn Ae Kim
Konkuk University Medical Center
Outcome results
None listed