KCT0006841已完成未知
A Phase 2, Multicenter, Single-Arm Study to Evaluate the Efficacy of Lazertinib in Patients with NSCLC Who Harboring EGFR T790M Mutation Detected by Bronchoalveolar Lavage Liquid (BALiquid)
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Provide signed and dated written consent prior to examination-specific procedures
- •2) Male and female adults 19 years of age or older
- •3) Patients with histologically or cytologically diagnosed non-small cell lung cancer (NSCLC) and at the time of enrollment locally advanced or metastatic inoperable (ie, stages IIIB to IV not suitable for definitive CCRT) or recurrent patients
- •4) Patients with positive EGFR mutations (L858R, E19del, L861Q, G719X) at the time of diagnosis
- •However, in addition to the EGFR mutation, it is also possible to enroll a case accompanied by de novo T790M.
- •5) Patients who have previously received EGFR-TKIs (gefitinib, erlotinib, afatinib, dacomitinib) and have confirmed disease progression (PD)
- •Regardless of the order of cytotoxic chemotherapy and EGFR-TKIs treatment in previous chemotherapy
- •At least one of the EGFR-TKIs must be used, regardless of the presence or absence of cytotoxic chemotherapy
- •6) Patients who can sufficiently collect BALiquid through bronchoscopy immediately before participating in this study after treatment with EGFR-TKIs (gefitinib, erlotinib, afatinib, dacomitinib)
- •7) Patients with positive T790M mutation in lung lavage fluid (BALiquid) by PANAmutyper assay
- •8) ECOG performance status 0~2
- •9) If the predicted survival period is more than 12 weeks
- •10) At least 1 measurable lesion (excluding brain) according to RECIST V1.1
- •11) Adequate bone marrow reserve or organ function in all of the following cases:
- •Absolute neutrophil count (ANC) = 1.5 x 109/L
- •Platelet count = 100 x 109/L
- •Hemoglobin = 9.0 g/dL
- •Alanine aminotransferase (ALT) = 2.5 times the upper limit of normal (ULN) if liver metastases cannot be demonstrated, or = 5x ULN if liver metastases are present
- •Aspartate aminotransferase (AST) = 2.5x ULN if liver metastases cannot be demonstrated, or = 5x ULN if liver metastases are present
- •Total bilirubin = 1.5x ULN in the absence of liver metastases, or = 3x ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases
- •Serum creatinine = 1.5x ULN
- •However, if the creatinine is > 1.5x ULN, registration is possible if the creatinine clearance measured by the general method of the testing institution (eg, Cockcroft and Gault equation) is = 50 ml/min.
- •12) Patients who agreed to use effective contraception during the clinical trial period
- •Women of childbearing potential (less than 1 year since the last menstrual period as of the date of consent) or male patients must be willing to use an effective method of contraception for at least 3 months after completion of Lazertinib administration must tell the truth.
排除标准
- •1) Patients who have previously taken or are currently taking other drugs targeting the T790M positive mutation
- •2) Patients who have taken strong cytochrome P450 (CYP) 3A4 inhibitors or inducers prior to at least 1 week of taking Lazertinib
- •3) All malignancies other than previous or coexisting lung cancer
- •However, non-melanomatous skin cancer, cervical carcinoma in situ, ductal carcinoma in situ, thyroid cancer, or malignant tumors that have been effectively treated for more than 3 years and are considered to be cured are excluded.
- •4) History of symptomatic requiring aggressive treatment chronic heart failure or serious cardiac arrhythmias
- •5) History of myocardial infarction or unstable angina prior to 24 weeks of study enrollment
- •6) Patients with clinically significant QTcB correction value > 480 msec on 12-lead ECG
- •7) History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonia requiring steroid treatment, or evidence of clinically active ILD
- •8) refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing the product, or past significant bowel resection that may interfere with the proper absorption of Lazertinib
- •9) History of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •10) Known active hepatitis B infection (defined as presence of HBsAg and/or HBV DNA), known active hepatitis C infection (defined as presence of HCV RNA) and/or known HIV carriers
- •11) Women who are pregnant or lactating, or who have a positive pregnancy test before registration in the clinical trial
- •12) Patients with severe hypersensitivity to the main ingredient or excipient of the test drug (lasertinib)
- •13) Patients with untreated active central nervous system (CNS) metastases confirmed by screening and prior CT or MRI evaluation
- •However, registration is possible in the following cases.
- •- Imaging and neurological stability after stopping the administration of corticosteroids and anticonvulsants for at least 2 weeks before enrollment after treatment for active central nervous system (CNS) metastases
- •- Patients with asymptomatic CNS metastases
- •14) uncontrolled infectious disease
- •However, infectious diseases that require parenteral antibiotic administration are excluded, but participation is possible after the infection is completely eliminated or controlled.
- •15) Patients who are unable to participate in the clinical trial at the discretion of the investigator, such as when it is difficult to comply with the procedures, restrictions, and requirements of the clinical trial protocol, or follow-up management
- •16) Patients who have administered other investigational drugs within 30 days prior to test administration
- •However, cases where gefitinib, erlotinib, afatinib, or dacomitinib are taken as clinical investigational drugs are excluded.
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