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临床试验/JPRN-jRCTs071210036
JPRN-jRCTs071210036进行中（未招募）2 期

Phase II Study of Platinum-Etoposide Durvalumab Combination Therapy for Extensive-Stage Small Cell Lung Cancer with Untreated Brain Metastases (LOGIK2001) - LOGIK2001(SPEED)

Okamoto Isamu0 个研究点目标入组 41 人开始时间: 2021年6月21日最近更新:
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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
41
研究概览入排标准研究者记录与标识符相似试验

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) Diagnosed with small cell lung cancer based on histology or cytology.
  • •(2) Extensive-stage/recurrence not indicated for radical irradiation/surgery.
  • •(3) Over 20 years old.
  • •(4) ECOG performance status (PS) of 0-2.
  • •(5) Not previously treated with systemic drug therapy for the target cancer of this study.
  • •(6) No prior drug therapy that specifically target the T cell co-stimulation or checkpoint pathway, such as anti-PD-1 antibody, anti-PD-L1 antibody, and anti-CTLA-4 antibody.
  • •(7) The presence of a lesion of untreated brain metastasis with a longest diameter of 5 mm or longer on head MRI regardless of the presence or absence of symptoms.Patients can be enrolled if they are asymptomatic or with mild symptoms which have been controlled for at least one week by anti-brain edema therapy with steroid at 40 mg or lower as prednisolone.
  • •(8) The absence of brain metastasis indicated for emergency radiation/surgery.
  • •(9) Patients with no measurable lesions other than brain metastases are also eligible.
  • •However, thoracicoabdominal CT performed within 28 days before registration is essential (28-day earlier same day of the week is acceptable).
  • •(i) No prior stereotactic radiotherapy or Gamma knife for central nervous system metastases within 7 days.
  • •(ii) No prior surgery for brain metastases within 7 days.
  • •(11) Adequate organ function.
  • •Neutrophil count:>= 1,500/mm3
  • •Hemoglobin:>= 9.0 g/dL
  • •Platelet count:>= 100,000/mm3
  • •AST,ALT:<= 2.5xULN (upper limit of normal) (<= 5.0xULN for liver metastasis cases)
  • •Total bilirubin:<= 1.5xULN
  • •Creatinine clearance:> 40 mL/min (Cockcroft-Gault formula)
  • •PaO2:>= 60 torr or SpO2:>= 90%
  • •(12) Survival for 12 weeks or longer is expected.
  • •(13) A body weight exceeding 30 kg.
  • •(14) Written informed consent for this study.

排除标准

  • •(1) Active double cancer.
  • •(2) Local or systemic active infection requiring surgical treatment, such as drainage.
  • •(3) Active hepatitis B and C.
  • •(4) Interstitial lung disease clearly observed on Chest CT.
  • •(5) After allogeneic organ transplantation.
  • •(6) Past medical history of primary immunodeficiency syndrome.
  • •(7) Complication by autoimmune disease or a past medical history of autoimmune disease requiring steroid therapy.
  • •(8) Requirement of continuous systemic administration (oral or intravenous) of steroid at a dose higher than 10 mg/day as predonisolone other than anti-edema therapy for autoimmune disease and brain metastasis and being treated with immunosuppressants.
  • •(9) Serious complication
  • •Cerebrovascular disorder within 1 year.
  • •Frequent transient ischemic attack.
  • •A past medical history of symptomatic congestive heart failure, unstable angina, and myocardial infarction within 1 year before registration.
  • •Clinically serious arrhythmia on electrocardiography (complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block).
  • •Complication by gastrointestinal perforation, fistula, and diverticulitis, or a past medical history of these within 1 year.
  • •Uncontrollable peptic ulcer.
  • •Poorly controlled diabetes.
  • •(10)Surgical treatment within 28 days (treatment on 2 week earlier same day of the week is acceptable). However, local surgery for isolated lesions for symptomatic relief is acceptable.
  • •(11) Live vaccine administration within 30 days before treatment initiation.
  • •(12) Hypersensitivity to drugs containing ingredients and additives of cisplatin, carboplatin, etoposide, and durvalumab.
  • •(13) Psychological disorder difficult to participate in this clinical study.
  • •(14) Pregnant women, lactating women, women who may be currently pregnant, or the absence of intention of contraception.
  • •(15) Judged as inappropriate by the clinical investigator.

研究者

发起方
Okamoto Isamu

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