JPRN-jRCT1051190091进行中（未招募）2 期
Docetaxel plus Ramucirumab immediately after treatment with immune checkpoint inhibitor in patients with advanced non-small cell lung cancer: A multicenter prospective single arm phase II study (DRUN study) - DRUN study
Akamatsu Hiroaki0 个研究点目标入组 35 人开始时间: 2020年1月8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
- 35
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. Written informed consent to participate in this study.
- •2. Histologically and/or cytologically proven non-small cell lung cancer.
- •3. Patients who have unresectable clinical stage IIIB, IIIC, or IV, post-operative recurrence or recurrence after radical radiation therapy.
- •4. Patient who have measurable lesions.
- •5. More than twenty years old at the time of the agreement acquisition
- •6. ECOG Performance Status 0-1
- •7. Meets the following criteria within 14 days before registration
- •a: leukocyte count: >=3000/mm3
- •b: neutrophil count: >=1500/mm3
- •c: hemoglobin: >=9.0 g/dL
- •d: platelet count: >=100,000/mm3
- •e: total bilirubin: <=1.5mg/dl
- •f: AST and ALT: <=100IU/L (<=200IU/L, in case of liver metastasis)
- •g: Cre: <=1.5mg/dl or CCr: >=40mL/min
- •h: PT-INR: <=1.5
- •i: SpO2: >=92% (room air)
- •j: protein urea: <=1+
- •If the amount of proteinuria is 2+ or more, it is eligible if the amount of proteinuria in 24 hours is less than 1000 mg. If measurement by 24 hour urine storage is difficult, measure the urinary protein quantification result (mg / dL) / urinary creatinine concentration (mg / dL) ratio, and substitute that value as the 24 hour urinary protein amount (g).
- •8. Patients who have previously treated with immu
- •ne checkpoint inhibitor and chemotherapy (It doesn't matter if it's simultaneous or sequential)
- •9. Patients who received treatment including ICI in the previous treatment
- •10. Patients with up to 2 lines of treatment so far
- •11. Patients who have passed the final day of the final course of previous treatment at the time of enrollment.
- •12. Patients with a history of radiation therapy could participate in the study if:
- •a: at least 3 months after chest radiation therap
- •b: at least 7 days after local or palliative radiation therapy (including stereotactic radiation to the central nervous system and whole-brain radiation)
排除标准
- •1. Patient with active double cancer.
- •2. Patient with infectious diseases that require systemic treatment.
- •3. Active interstitial pneumonitis, fibroid lung confirmed by CT.
- •4. Uncontrollable diabetes.
- •5. Uncontrollable hypertension despite standard medical management.
- •6. congestive heart failure (NYHA II-IV) and arrhythmias that cannot be controlled with drugs.
- •7. Patients with intestinal obstruction. patients with a history of inflammatory bowel disorders, extensive bowel resection, Crohn's disease, ulcerative colitis or chronic diarrhea.
- •8. Patients with a history of uncontrollable thrombosis / embolism.
- •9. HBs antigen positive.
- •10. HBs antibody or HBc antibody is positive and HBV-DNA is positive.
- •11. Patient with HIV-related diseases.
- •12. Patient with impaired mental status.
- •13. Child-Pugh B (or more severe) cirrhosis, or history of hepatic encephalopathy or cirrhosis with clinically significant ascites (regardless of severity).
- •14. Patients with grade 3 or higher peripheral neuropathy.
- •15. Pregnancy.
- •16. Symptomatic brain metastases or spinal metastases that require radiation or surgery.
- •17. Symptomatic superior vena cava syndrome.
- •18. Patient with much ascetic fluid, pleural effusion, cardiac effusion.
- •19. Image findings.
- •a. Obvious tumor invasion to main thoracic vessel or main blood vessel stenosis
- •b. Cavity in the tumor
- •c. Tumor exposure to the central airway to the regional branch
- •20. Patients who have undergone surgery with general anesthesia within 28 days, subcutaneous venous access devices in place within 7 days, or postoperative bleeding complications or wound complications due to surgical treatment within 2 months.
- •21. History of ramucirumab treatment.
- •22. Receiving steroids in excess of 10mg/day prednisolone equivalent.
- •23. Patients who have used study drug or unapproved therapy within the past 3 months. Registration is possible if the doctor in charge determines that the effect and safety will not be affected.
- •24. Fever over 38
- •25. History of bleeding within 2 months
- •26. Patients with arterial thrombosis such as myocardial infarction, unstable angina, cerebrovascular attack or transient ischemic attack within 6 months.
- •27. Serious or non-healing wounds, ulcers or fractures within 28 days
- •28. Serious bleeding disorders, vasculitis or Grade 3 or higher gastrointestinal bleeding within 3 months
- •29. Patient with gastrointestinal perforation within 6 months.
- •30. History of hypersensitivity to the components of the study drug.
- •31. Patients scheduled for major surgery during the study period.
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