KCT0006207尚未招募未知
Phase II Trial of Lazertinib in Patients with Epidermal Growth Factor Receptor Sensitizing Mutation Positive, Metastatic Non-Small Cell Lung Cancer with Asymptomatic or Mild Symptomatic Brain Metastases After Failure of EGFR Tyrosine Kinase Inhibitor
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 40
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
- 20?(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1)Written consent
- •A.Patients who voluntarily provided written informed consent prior to participation in the clinical trial
- •B.Patients who voluntarily provide written informed consent for genetics and/or exploratory studies
- •2)Age and gender
- •A.Male or female, 20 years of age or older
- •B.Female patients must agree to the use of appropriate contraceptive methods and not be lactating, and for women of childbearing age, there must be evidence that the pregnancy test is negative prior to initiation of dosing, or that they are not fertile because they meet one of the following criteria at screening: box
- •?Postmenopausal” women over the age of 50 and who are amenorrhea for at least 12 months after stopping all exogenous hormone therapy
- •?Records of irreversible surgical infertility by hysterectomy, bilateral ovariectomy, or bilateral yolk resection, tubal ligation are not permitted
- •?Women under 50 years of age had amenorrhea for at least 12 months after stopping all exogenous hormone therapy, and the levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) were within the postmenopausal range of the laboratory. Is only recognized as a postmenopausal condition
- •?For women of childbearing age, appropriate contraception method should be used to 24 weeks after taking the last investigational drug
- •C.Male patients who have not undergone vasectomy must consent to the use of a blocking contraception method, i.e., condom, and sperm supply is prohibited until 24 weeks after taking the last investigational drug
- •3)Target disease
- •A.Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer patients. This may occur as systemic recurrence after prior surgery for early stage disease or patients may be newly diagnosed with stage IIIB/C or IV disease.
- •B.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2, with no deterioration in the last 2 weeks
- •C.Life expectancy judged by the Investigator of at least 3 months
- •Asymptomatic or mild symptomatic brain metastases progressed or newly confirmed patients
- •E. For one or more intracranial measurable disease, the maximum baseline diameter is measured to be 10mm or more on CT or MRI, and this lesions can be ccurately measured. (The target lesion that has received previous local therapy should not be considered as measurable. However, new CNS lesion after more than 3 months of previous local therapy could be considered as target lesion. )
- •F. Confirmed sensitizing EGFR mutation prior to administration of gefitinib, erlotinib, or afatinib (L858R, Exon 19 deletion, G719X and L861Q mutations chould be confirmed as a record)
- •G. Failure after one regimen of EGFR TKI treatment. Past treatment history for locally advanced or metastatic NSCLC limited to one regimen of EGFR TKI treatment (gefitinib, erlotinib, or afatinib) and/or one palliative cytotoxic chemotherapy regimen.
- •H. Those who have been confirmed status of T790M mutations in tissues or blood after EGFR TKI failure (T790M positive or negative should be confirmed as a record)
排除标准
- •The following interventional treatment
- •A.Prior treatment with lazertinib
- •B.Prior treatment with investigational drugs in other clinical trials within 30 days prior to the first administration
- •C.Patients who received cytotoxic chemotherapy for the treatment of advanced non-small cell lung cancer or other anticancer drugs other than EGFR TKI within 14 days prior to the first administration of the investigational drug
- •D.Prior local-regional therapy within 4 weeks prior to Day 1 of trial treatment (e.g., major surgery, radiation therapy [with the exception of palliative bone-directed radiotherapy and radiotherapy administered to superficial lesions], hepatic arterial embolization, transcatheter arterial chemoembolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation)
- •NOTE: palliative bone-directed radiotherapy should be within a limited field of radiation and for palliation only; it should be a short course, according to local institutional recommendations, and should be completed at least 7 days prior to the first administration of trial treatment
- •E.Patients currently receiving drugs or herbal supplements known as inhibitors or inducers of CYP3A4 or who cannot discontinue use at least 1 week prior to the first dose of lazertinib.
- •F.Previous anticancer treatment-related toxicities not recovered to baseline or Grade 0-1 (except alopecia)
- •1)Medical history and current disease
- •A.Symptomatic spinal cord compression (However, registration is allowed if steroid treatment is not required within at least 2 weeks before the start of administration of the investigational drug)
- •B.Symptomatic and unstable central nervous system (CNS) or brain metastasis requiring local treatment at screening. (Asymptomatic or mild symptomatic leptomeningeal metastasis is also permitted to be registered)
- •C.Symptomatic or intracranial bleeding that needs treatment
- •D.History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
- •E.Carcinoma other than non-small cell lung cancer, if the investigator is judged to be inadequate to participate in this clinical trial due to evidence of severe or uncontrolled systemic disease, uncontrolled hypertension, or active bleeding tendency, or that it is difficult to follow this protocol. (Screening for chronic disease is not required)
- •F.Any of the following cardiovascular diaseases:
- •i.A history of congestive heart failure (CHF) of grade 3 or higher according to the New York Heart Association Classification (NYHA) or cardiac arrhythmia requiring treatment
- •ii.A History of unstable angina or myocardial infarction experienced within 6 months before the first administration of the investigational drug
- •iii.Left ventricular ejection fraction <50% on recent echocardiography or MUGA scan
- •G.Known human immunodeficiency virus (HIV) infection
- •H.Patient has known active hepatitis B virus(HBV) or hepatitis C virus (HCV) infection
- •I.Patients with refractory nausea and vomiting, chronic gastrointestinal disorders, inability to swallow the product, or undergoing enterectomy deemed to interfere with the proper absorption of lazertinib.
- •J.History of hypersensitivity to drugs
- •K.Clinically significant chronic infection or major medical or mental illness
- •L.Subjects with any concurrent medical condition or disease that will potentially compromise the conduct of the study
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