JPRN-jRCTs071220008招募中2 期
Phase II trial of carboplatin + nab-paclitaxel + atezolizumab combination therapy for TTF-1 negative advanced non-squamous non-small cell lung cancer - LOGIK2102
Okamoto Isamu0 个研究点目标入组 52 人开始时间: 2022年4月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
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) No prior systemic chemotherapy.
- •(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) Has a lesion on imaging. (With or without measurable lesion)
- •(6) Over 20 years old.
- •(7) Performance status 0 or 1.
- •(8) No driver-oncogene alterations.
- •(9) TTF-1 is negative for IHC
- •(10) No symptomatic brain metastasis.
- •(11) 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.
- •(12) Adequate organ function.
- •(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) Serum creatinine =< 1.5 mg/dL
- •(13) 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.
- •(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.
- •(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
相似试验
已完成
不适用
Phase II trial of nab-paclitaxel and carboplatin with concurrent radiotherapy for patients with locally advanced non-small cell lung cancernon-small cell lung cancerJPRN-UMIN000019611Department of Radiation Oncology, Yamaguchi University Hospital37
已完成
2 期
Phase II study of Carboplatin plus nab-Paclitaxel for advanced non-small cell lung cancer patients with interstitial lung diseaseAdvanced non-small cell lung cancer with interstitial lung diseaseJPRN-UMIN000012989Kanagawa Cardiovascular and Respiratory Center90
招募中
1 期
PhaseI/II study of carboplatin plus nab-paclitaxel plus bevacizumab administered to advanced non-squamous non-small cell lung cancer.advanced non-squamous non-small cell lung cancerJPRN-UMIN000013333agoya City West Medical Center35
已完成
2 期
Phase 2 study of Carboplatin plus nab-Paclitaxel for patients with PS 2 advanced NSCLC(TORG1426)on small cell lung cancerJPRN-UMIN000019458PO Thoracic Oncology Research Group42
已完成
2 期
Phase II study of nab-paclitaxel and carboplatin with concurrent thoracic radiotherapy in patients with unresectable locally advanced non-small cell lung cancerJPRN-UMIN000011681Gifu Municipal Hospital32