JPRN-jRCTs031210688进行中（未招募）2 期
A Phase II Study of Nivolumab and Ipilimumab in Combination with Chemotherapy after Lung Stereotactic Body Radiotherapy as First-Line Therapy in Stage IV Non-Small Cell Lung Cancer. - NEJ053C
Hosomi Yukio0 个研究点目标入组 40 人开始时间: 2022年3月22日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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 as non-small cell lung cancer by either histology or cytology.
- •(2) Diagnosed as clinical stage IV (UICC-TNM classification, 8th edition) or postoperative recurrence.
- •(3) No prior systemic chemotherapy for lung cancer.
- •(4) No history of chemotherapy with immune checkpoint inhibitors for other cancer types.
- •(5) For non-squamous NSCLC, EGFR gene mutation is negative.
- •(6) Negative or unknown for ALK fusion gene, ROS1 fusion gene, BRAF (V600E) mutation, MET exon 14 skipping mutation, RET fusion gene, or NTRK fusion gene.
- •(7) Age 20 years or older at the date of registration.
- •(8) A baseline Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- •(9) PD-L1 (22C3) expression is not required.
- •(10) Patients must have primary pulmonary lesion, mediastinal or hilar lymph node metastases, or any of them, amenable to radiotherapy.
- •(11) Patients with measurable lesions.
- •(12) No symptomatic brain metastases, meningeal carcinomatosis, or spinal metastases requiring radiotherapy or surgery.
- •(13) No autoimmune disease and no history of chronic or recurrent autoimmune disease.
- •(14) Patients are expected to survive for at least 12 weeks.
- •(15) Patients obtain written informed consent.
排除标准
- •(1) Patients with concurrent multiple cancers or heterogeneous multiple cancers with a disease-free interval of 2 years or less
- •(2) Patients with interstitial pneumonia, drug-induced interstitial lung disease, or clinically active interstitial lung disease on chest CT scan
- •(3) Patients with a history of radiotherapy to the chest
- •(4) Patients with symptoms such as dyspnea associated with SVC syndrome or airway stenosis who require palliative radiotherapy to the chest
- •(5) Patients who are receiving oxygen
- •(6) Patients with infections that require systemic treatment.
- •(7) Patients who are receiving continuous systemic administration of steroids or other immunosuppressive drugs at a dose higher than 10 mg/day of prednisolone equivalent.
- •(8) Patients with serious complications.
研究者
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