eoadjuvant Lazertinib Therapy in Resectable EGFR-Mutation Positive Lung Adenocarcinoma Patients Detected by Bronchoalveolar lavage fluid Liquid Biopsy

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0007214
• Lead Sponsor: Konkuk University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective response rate

Secondary Outcome Measures

Name	Time	Method
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