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临床试验/JPRN-jRCTs071180049
JPRN-jRCTs071180049已完成3 期

A randomized phase III study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosis - J-SONIC

Okamoto Isamu0 个研究点目标入组 243 人开始时间: 2019年3月15日最近更新:
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适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
243
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

Chemotherapy is effective and tolerable for advanced NSCLC patients with non-severe IPF. Nintedanib in combination with chemotherapy is a treatment option for these patients, especially for those with nonsquamous histology.

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
  • •2) 20 years of age or older
  • •3) Histologically or cytologically proven non-small cell lung carcinoma
  • •4) Clinical stage III, IV or recurrent disease after surgery
  • •5) With or without measurable lesions
  • •6) Without symptomatic central nervous system metastases
  • •7) Without uncontrollable cardiac effusion, pleural effusion, ascites, superior vena cava syndrome or spinal cord compression
  • •8) No prior chemotherapy
  • •9) No history of treatment with nintedanib, nab-paclitaxel or immune checkpoint inhibitor
  • •10) No prior operation under general anesthesia within 14 days before registration
  • •11) No prior palliative radiotherapy within 14 days before registration
  • •12) No prior biopsy under incision, thoracoscopic biopsy, or treatment for wound occurred within 7 days before registration
  • •13) No prior blood transfusion or hematopoietic factor administration within 7 days before registration
  • •14) No history of treatment with pirfenidone, cyclophosphamide, cyclosporine within 56 days before registration
  • •15) No history of systemic treatment with steroid at a daily dose of more than 15mg in prednisolone equivalent.
  • •16) Definite honeycomb lung destruction with basal and peripheral predominance or presence of reticular abnormality and traction bronchiectasis consistent with fibrosis with basal and peripheral predominance.
  • •17) DLCO 36% to 79% predicted of normal
  • •18) FVC >/= 50% predicted of normal
  • •19) SpO2 >/= 90% or PaO2 >/= 60 torr
  • •under room air conditions
  • •20) ECOG performance status of 0 or 1
  • •21) Correspond to the following values in laboratory tests performed within 14 days before registration
  • •a. Neutrophil count >/= 1,500 /mm3
  • •b. Hemoglobin >/= 8.0 g/dL
  • •c. Platelet count >/=100,000 /mm3
  • •d. Total bilirubin e. AST f. ALT g. Creatinine h. PT-INR i. Proteinuria </= Grade1 (CTCAE ver 4.0)

排除标准

  • •1) Ground glass opacity is less extensive than reticular opacity pattern
  • •2) History of acute exacerbation of IPF
  • •3) Other interstitial lung disease of known etiology including infection, pneumoconiosis, drug-induced pneumonitis, sarcoidosis, and collagen vascular disease
  • •4) Synchronous or metachronous active double malignancies
  • •5) With serious complications
  • •6) With high bleeding risks
  • •7) Local or systemic active infection that requires treatment
  • •8) Pregnant, possibly pregnant or breastfeeding, or unwilling to practice contraception during the study
  • •9) Severe psychiatric diseases
  • •10) History of serious drug allergies
  • •11) Other conditions not suitable for this study

研究者

发起方
Okamoto Isamu

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