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临床试验/JPRN-jRCT2061230039
JPRN-jRCT2061230039招募中2 期

Phase II study of combination treatment of nivolumab and TM5614, a PAI-1 inhibitor for patients with non-small cell lung cancer (TM-Uprise Study)

Hattori Noboru0 个研究点目标入组 39 人开始时间: 2023年7月19日最近更新:
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适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
39
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
>= 18age old 至 ot applicable（—）
性别
All

入选标准

  • •(1) Age of >=18 years at the time of informed consent
  • •(2) Provision of written informed consent
  • •(3) Histologically confirmed stage III with no indication for curative surgery, radiotherapy, stage IV, or recurrent NSCLC
  • •(4) No sensitizing epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements in patients with non-squamous carcinoma
  • •(5) No or unknown ROS-1 rearrangement, BRAF (V600E) gene mutation, MET exon 14 skipping mutation, RET rearrangement, or NTRK rearrangement.
  • •(6) Disease progression during or after the most recent treatment and history of treatment
  • •- Platinum doublet chemotherapy
  • •- Immune checkpoint inhibitors (e.g. nivolumab, pembrolizumab, atezolizumab, nivolumab, and ipilimumab)
  • •- Chemotherapy (e.g. pemetrexed, docetaxel, nab-paclitaxel, S-1)
  • •(7) Measurable lesions based on Response Evaluation Criteria in Solid Tumors (RECIST) Ver.1.1
  • •(8) Eastern Cooperative Oncology Group performance status of 0-1
  • •(9) Estimated life expectancy of >=90 days
  • •(10) Adequate organ function within 7 days prior to registration. The laboratory values must not have received granulocyte colony stimulating factor (G-CSF) administration or blood transfusion within 14 days prior to the test.
  • •- Neutrophil count greater than 1,500/mm3
  • •- Platelet count greater than 100,000/mm3
  • •- Hemoglobin is 8.5 g/dL or higher
  • •- AST and ALT less than or equal to 3 times the upper limit of the reference value of the medical institution performing the procedure.
  • •If the patient has liver metastasis, AST and ALT are 5 times or less than the upper limit of the reference value of the implementing medical institution.
  • •- Total bilirubin is 2 times or less than the upper limit of the reference value at the institution.
  • •- Creatinine is 1.5 mg/dL or less, or creatinine clearance is 45 mL/min or more as measured or estimated by Cockcroft/Gault formula.
  • •- SpO2 greater than 90% (room air)

排除标准

  • •(1) Active autoimmune disease that has required systemic treatment using corticosteroids or other immunosuppressive medication.
  • •(2) History of serious immune-related adverse events caused by anti-PD-1/anti-PD-L1 antibodies.
  • •(3) Patients receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive drugs exceeding 10 mg/day of prednisolone equivalent.
  • •(4) Multiple cancers.
  • •(5) Central nervous system metastases (symptomatic or requiring treatment).
  • •(6) Carcinomatous meningitis.
  • •(7) Evidence of interstitial pneumonia , Pulmonary fibrosis , Radiation pneumonitis.
  • •(8) Uncontrollable pleural effusion, ascites, or pericardial fluid.
  • •(9) Patients with stable and uncontrolled tumor-related pain.
  • •(10) Patients who have received external-beam or whole-brain irradiation of metastases within 14 days prior to enrollment.
  • •(11) Patients with bleeding tendency.
  • •(12) Patients with systemic infections requiring treatment.
  • •(13) Patients with uncontrolled diabetes mellitus.

研究者

发起方
Hattori Noboru

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