JPRN-jRCTs041200100进行中（未招募）2 期
First-Line Osimertinib for Poor Performance Status Patients with EGFR Mutant Non-Small Cell Lung Cancer - TORG2040
Katsuhiko Naoki0 个研究点目标入组 30 人开始时间: 2021年2月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Histologically or cytologically diagnosed as non-small cell lung cancer.
- •2) Confirmed tissue specimens or cytological specimens with EGFR-sensitive gene mutations (EGFR Ex18 G719X, Ex19 DEL, Ex21 L858R, Ex21 L861Q).
- •(In such mutation, compound mutations other than Ex20 insertion mutations are allowed.)
- •3) Clinical stage III/IV or postoperative recurrence in which definitive surgery and radiation are not possible (UICC-TNM classification 8th edition).
- •4) Age of 20 years or older at the time of consent.
- •5) ECOG PS 2-4 (PS decrease due to the underlying lung cancer judged by the attending doctor), and expected survival of 12 weeks or more.
- •6) Having measurable lesions based on Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 (however, the site where irradiation was performed is not a measurable lesion).
- •7) Untreated cases of drug therapy for lung cancer including EGFR-TKI, immune checkpoint inhibitors, cytotoxic anticancer drugs. Preoperative and postoperative chemotherapy excluding EGFR-TKIs is acceptable if the final dose is at least 6 months prior to enrollment in this study.
- •8) No severe impairment in the major organ function, and the following criteria are met:
- •(Must be met within 14 days from the registration date. The same day of the week two weeks before the registration date is acceptable)
- •A) Number of neutrophils: 1,500/mm3 or more,
- •B) Hemoglobin: 9.0 g/dL or more,
- •C) Platelet count: 10.0 x 10,000/mm3 or more,
- •D) AST: 2.5 times or less of the upper limit of the institutional standard value (5 times or less if there is liver metastasis),
- •E) ALT: 2.5 times or less of the upper limit of the facility standard value (5 times or less if there is liver metastasis),
- •F) Total bilirubin: 1.5 times or less of the upper limit of the facility standard value (3 times or less if Gilbert's syndrome [non-conjugated hyperbilirubinemia] or liver metastasis is present),
- •G) Serum creatinine: 1.5 times or less of the facility standard value upper limit (however, if it exceeds 1.5 times the facility standard value upper limit, patients with creatinine clearance [measured value or value calculated by Cockcroft-Gault formula] of 50 ml/min or more are eligible), and
- •H) SpO2: 90% or more (with or without oxygen therapy, except for cases requiring positive pressure ventilation).
- •9) Written consent obtained from the patient after a sufficient explanation of the study content has been given prior to enrollment in this study.
排除标准
- •1) Known EGFR Ex20 insertion mutation.
- •2) Having active double/multiple cancer (simultaneous double cancer/multiple cancer and metachronous double cancer/multiple cancer requiring treatment within 2 years of disease-free period). However, lesions equivalent to carcinoma in situ and intramucosal cancer that are judged to be cured by local treatment are not included in active double cancer/multiple cancer.
- •3) Interstitial lung disease, drug-induced interstitial lung disease, history of radiation pneumonia requiring steroid treatment, or active period interstitial lung disease.
- •4) Ingestion is not possible. Having a history of refractory nausea and vomiting, chronic gastrointestinal disorders, aphagia, or gastrointestinal resection that may significantly affect the absorption of osimertinib.
- •5) An active infection that requires systemic treatment (Active infections include all cases treated by intravenous administration for the infection).
- •6) Having difficulty in participation in the study because of clinically problematic psychosis or psychiatric symptoms.
- •7) Clinically unstable brain metastases.
- •8) Serious complications (severe or uncontrolled systemic disease including uncontrollable hypertension and active bleeding diathesis.)
- •9) Systemic administration of steroids for 4 weeks or longer. However, steroids within 20 mg/day in terms of prednisolone are acceptable.
- •10) PS decrease due to comorbidities including sequelae of cerebral infarction. However, for cases of coelomic fluid retention, cases for which this drug is administrable after drainage or adhesions can be registered.
- •11) At the time of enrollment, CTCAE grade 2 or higher toxicity due to systemic pretreatment including adjuvant chemotherapy continues, excluding alopecia and grade 2 neuropathy due to pretreatment chemotherapy.
- •12) One of the following treatments is being performed;
- •- underwent major surgery excluding blood vessel securing surgery within 4 weeks before registration,
- •- received more than 30% of bone marrow or extensive radiation therapy within 4 weeks prior to enrollment.
- •- patients who are taking drugs or herbal supplements known to have a strong inducing effect on Cytochrome P450 (CYP) 3A4 (or who cannot be discontinued at least 1 week before the first dose), and
- •- treatment with another investigational drug was received within 5 times the half-life of the compound, or 3 months, whichever is longer.
- •13) QT prolongation on resting electrocardiogram (Bazett's correction formula: QTc [= QT measured value/RR interval 1/2] exceeds 470 msec), clinically significant abnormalities in heart rate rhythm, conduction, and waveform (for example, complete left bundle branch block, 2nd to 3rd degree atrioventricular block, PR extension [more than 250 msec]).
- •14) QTc prolongation or Torsades de Pointes or factors that increase the risk of arrhythmia induction (heart failure, hypokalemia/hypokalemia/hypocalcemia and other electrolyte abnormalities, congenital long QT syndrome, cases with first-time relatives with a family history of long QT syndrome, cases with a family history of sudden death of unknown cause under the age of 40, cases using concomitant medications known to cause QT interval prolongation or Torsades de Pointes).
- •15) Having a history of hypersensitivity to the active ingredient or excipient of osimertinib, or a drug of the same chemical structure or class as osimertinib.
- •16) Pregnant women, lactating women, women with a positive pregnancy test, or no intention o
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