JPRN-jRCTs031210013进行中（未招募）3 期
JCOG2007: A Multicenter Randomized Phase III Study comparing Pembrolizumab + Platinum Combination Chemotherapy with Nivolumab + Ipilimumab + Platinum Combination Chemotherapy for Treatment-naive Advanced Non-Small Cell Lung Cancer without Driver Gene alteration - Pembro + Chemo vs Nivo + Ipi + Chemo Phase III (NIPPON)
OKAMOTO Isamu0 个研究点目标入组 422 人开始时间: 2021年4月6日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 422
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 (including biopsy) or histologically confirmed 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) No EGFR gene mutations for non-squamous cell carcinoma.
- •(6) Negative or unknown ALK fusion gene, ROS1 fusion gene, BRAF (V600E) gene mutation, MET exon 14 skipping mutation, RET fusion gene, or NTRK fusion gene.
- •(7) Over 20 years old.
- •(8) Performance status 0 or 1.
- •(9) Eligible regardless of PD-L1 (22C3) expression.
- •(10) Measureable or non-measureable.
- •(i) No prior palliative radiation therapy for non-central nervous system metastases within 7 days
- •(ii) No prior stereotactic irradiation and Gamma-knife for central nervous system metastases within 7 days
- •(iii) No prior whole-brain irradiation within 14 days
- •(iv) No prior pleural drainage within 7 days
- •(v) No prior surgery with general anesthesia within 14 days
- •(12) No symptomatic brain metastasis, leptomeningeal metastasis, or spinal cord metastasis requiring radiotherapy or surgical operation.
- •(13) No active autoimmune disease.
- •(14) No findings suggestive of interstitial lung disease or pulmonary fibrosis on the chest computed tomography.
- •(15) Adequate organ funcion.
- •(16) Written informed consent for this study.
- •(17) Written informed consent for pretreatment stool collection for ancillary studies.
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) Pyrexia of 38 degrees centigrade or higher.
- •(4) During pregnancy, within 28 days of postparturition, or during lactation.
- •(5) Psychological disorder difficult to participate in this clinical study.
- •(6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
- •(7) Diabetes mellitus uncontrollable with the appropriate treatment.
- •(8) History of stroke within 1 year or frequent transient ischemic attacks.
- •(9) Symptomatic congestive heart failure, unstable angina, or a history of myocardial infarction within 6 months.
- •(10) Clinically serious arrhythmia on the electrocardiogram.
- •(11) Positive for serum hepatitis B surface antigen.
- •(12) HIV antibody positive.
- •(13) Grade 2 or higher peripheral neuropathy.
- •(14) Hypersensitivity to the ingredients / additives of carboplatin, pemetrexed, paclitaxel, nab-paclitaxel, pembrolizumab, nivolumab, and ipilimumab.
研究者
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