Neoadjuvant Lazertinib Therapy in EGFR-Mutation Positive Lung Adenocarcinoma Detected by BALF Liquid Biopsy

Korábbi kezelés

• 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

Más betegség

• Uncontrolled active interstitial lung disease
• Pathologically confirmed N3 disease
• Uncontrolled stage III-IV other malignancy
• Gastrointestinal diseases (e.g. Chron's disease, ulcerative colitis) or malabsorption syndrome that would impact on drug absorption
• Active infection requiring ongoing treatment(e.g. active Hepatitis B virus, Hepatitis C virus or Human immunodeficiency virus)
• History of hypersensitivity to active or inactive excipients of Lazertinib or drugs with a similar chemical structure.

Egyéb

• No ability to comply with protocol requirements.

• 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
• Patients not previously treated with EGFR-TKIs such as gefitinib, erlotinib, afatinib, dacomitinib
• Patients with the measurable lesion of 1 cm or more according to RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) 0-1
• EGFR-TKIs (gefitinib, erlotinib, afatinib,dacomitinib) naive patients
• Patients with adequate pulmonary and heart function for surgery
• Adequate organ function defined as Hemoglobin ≥ 9.0g/dL Absolute neutrophil count ≥ 1500/mm3 Platelet ≥ 100,000 /mm3 Serum creatinine≤ normal range*1.5x Aminotransferase/Alkaline phosphatase ≤normal range*2.5x Total bilirubin ≤1.5 mg/dL Liver metastasis: Aminotransferase/Alkaline phosphatase ≤ normal range* 5x Bone metastasis Alkaline phosphatase ≤ normal range* 5x
• Female patients with childbearing potential should be using adequate contraceptive measures. Female patients must have evidence of non-child-bearing potential(Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments)
• Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception for at least 14 days prior to administration of the first dose of study treatment, during the study, and for 3 months following the last dose of Lazertinib.