A Phase 2, Single Center, Single Arm, Prospective Study of Neoadjuvant Lazertinib Therapy in Resectable EGFR-Mutation Positive Lung Adenocarcinoma Patients Detected by Bronchoalveolar lavage fluid(BALF) Liquid Biopsy (NeolaBAL)

Konkuk University Medical Center0 个研究点目标入组 40 人开始时间: 待定最近更新: 2022年5月2日

适应症

试验速览

暂无简介。

•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

•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

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