JPRN-jRCTs071200102进行中（未招募）2 期
Phase II study of carboplatin/nab-paclitaxel/atezolizumab combination therapy for advanced non-squamous NSCLC with impaired renal function - LOGIK2002(RESTART)
Okamoto Isamu0 个研究点目标入组 25 人开始时间: 2021年2月25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
- 25
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) Cytologically or histologically confirmed non-squamous non-small cell lung cancer.
- •(2) Clinical stage III without indication of definitive thoracic radiotherapy, stage IV, postoperative recurrent disease, or recurrence after radiation therapy.
- •(3) Either (i) or (ii) for prior treatment.
- •(i) A patient who is negative or unknown for driver genetic mutations must meet the following criteria:
- •a) Active EGFR mutation is negative.
- •b) ALK, ROS1, BRAF (V600E), MET, RET, NTRK mutation are negative or unknown.
- •No prior systemic chemotherapy.
- •(ii) A driver genetic mutation-positive patient must meet the following criterion:
- •Confirmed progression after at least one line of targeted therapy for each driver mutation and no other prior systemic therapy. At least 7 days since last molecularly targeted therapy at the start of protocol therapy.
- •(4) 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.
- •(5) measurable lesion
- •(6) Over 20 years old.
- •(7) Performance status 0 or 1.
- •(8) No symptomatic brain metastasis.
- •(9) If the following prior treatment is performed before registration, the specified period has passed since the end of the treatment.
- •(i) No prior stereotactic irradiation and Gamma-knife for central nervous system metastases within one day.
- •(ii) No prior whole-brain irradiation within 7 days.
- •(iii) No prior palliative radiation therapy for non-central nervous system metastases within 7 days.
- •(iv) No prior pleural drainage within 7 days.
- •(v) No prior surgery with general anesthesia within 14 days.
- •(10) Adequate organ function other than kidney.
- •(i) Neutrophil count >= 1,500/mm3
- •(ii) Hemoglobin >= 9.0 g/dL
- •(iii) Platelet count >= 100,000/mm3
- •(iv) AST, ALT =<100 IU/L(cases with liver metastases AST, ALT =<200 IU/L)
- •(v) T.bil =< 1.5 mg/dL
- •(vi) Creatinine clearance:over 15 mL/min and less than 45 mL/min, excluding hemodialysis patients.
- •(11) Written informed consent.
排除标准
- •(1) Synchronous double or multiple cancer or metachronous double or multiple cancer within 2 years.
- •(2) Infectious disease requiring systemic treatment.
- •(3) Active hepatitis B and active hepatitis C.
- •(4) Findings suggestive of interstitial lung disease or pulmonary fibrosis on the chest computed tomography.
- •(5) Active autoimmune disease.
- •(6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
- •(7) Has serious complications.
- •(i) Frequent transient ischemic attacks.
- •(ii) Symptomatic congestive heart failure, unstable angina, or a history of myocardial infarction within a year.
- •(iii) Clinically serious arrhythmia on the electrocardiogram.
- •(iv) Gastrointestinal perforation, fistula, diverticulitis within a year.
- •(v) Uncontrollable peptic ulcer.
- •(vi) Diabetes mellitus uncontrollable with the appropriate treatment.
- •(8) Grade 2 or higher peripheral neuropathy.
- •(9) Hypersensitivity to the ingredients / additives of carboplatin, nab-paclitaxel, and atezolizumab.
- •(10) Psychological disorder difficult to participate in this clinical study.
- •(11) During pregnancy, within 28 days of postparturition, or during lactation.
- •(12) Other cases that the doctor considers inappropriate.
研究者
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