KCT0005919招募中未知
Phase II study of LAZertinib And pemetrexed in EGFR mUtant NSCLC patients with leptomeningeal carcinomatosis
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 43
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) Adults over 19 years of age at the time of receipt of ICF
- •2) There is a histological or cytological confirmation of NSCLC
- •3) Leptomeningeal carcinomatosis confirmed by CSF cytology (synchronous or metachronous LMC are both eligible)
- •4) In case of EGFR gene activity mutation (exon19 deletion or exon21 L858R, etc.).
- •(Regardless of T790M, registration is possible, exceptionally, only Exon20 insertion mutations cannot be registered)
- •5) ECOG performance status 0-3
- •6) A patients who signed the informed consent prior to the participation in the study
- •7) Registration is possible even if you have received previous treatment including EGFR-TKI (however, registration is not possible if you have received 3rd generation EGFR-TKI treatment [Osimertinib, lazertinib, olmutinib]). In the case of previous cytotoxic chemotherapy or immune chemotherapy, registration is possible regardless of the order of treatment, and registration is possible even when receiving pemetrexed.
- •8) Has suitable organ function, indicated by the following laboratory values:
- •? Absolute neutrophil count (ANC) =1,500cells/mm3
- •? Platelets =100,000cells/mm3;
- •? Total bilirubin =1.5 x upper limit of normal (ULN)
- •? Aspartic acid aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 x ULN (for liver metastasis = 5.0 x ULN)
- •? Serum creatinine =1.5 x upper limit of normal (ULN) or CCr = 45mL/min (calculated using weight-based Cockcroft-Gault formula)
排除标准
- •1) Subjects during pregnancy or lactation, or women planning to become pregnant during clinical trials
- •2) All female subjects who can conceive must have a negative pregnancy test (serum or urine) performed within 7 days prior to the first administration of the investigational drug (if amenorrhea for more than 12 months is considered menopause).
- •3) Men who are sexually active with women of childbearing potential must agree to continue contraception throughout the clinical trial, up to six months after the final administration of the trial intervention. Men must use condoms, and their partners must also be using highly efficient contraception (i.e., the established use of oral combined hormonal contraception; insertion of an intrauterine device or an intrauterine system). Even if the participant has undergone a vasectomy, she still needs to use a condom, but the female partner does not need to use contraception. In addition, participants must never donate sperm during the trial and for 6 months after receiving the last dose of the trial intervention.
- •4) A patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer
- •5) Excluding lymphangitic lung metastasis, interstitial lung disease, weak-causing interstitial lung disease, past history of radiation-induced pneumonia requiring steroid therapy, or evidence of clinically active interstitial lung disease
- •6) Serious illnesses including
- •-Clinically significant and uncontrolled arrhythmia
- •-History of myocardial infarction within 6 months before the start of clinical trial drug
- •-Mental illness or dementia that would interfere with cooperation with the requirements of this clinical trial
- •7) In case of receiving whole brain radiation treatment within 90 days before starting clinical trial drug
研究者
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