JPRN-UMIN000004194已完成3 期
A randomized phase III study of continuous maintenance Bevacizumab with or without Pemetrexed after induction therapy of Carboplatin, Pemetrexed, and Bevacizumab in patients with advanced non-squamous non-small-cell lung cancer whose EGFR mutation status is not active (other than Exon 19 deletion or Exon 21 point mutation) or is not known - Continuous maintenance of bevacizumab with or without pemetrexed for advanced non-squamous non-small cell lung cancer (COMPASS)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 620
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
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Induction therapy 1)Have CNS metastasis. (A case with locally treated asymptomatic brain metastasis can be registered.) 2)Have received radiation therapy to lesions of lung 3)Currently have or have a history of a cardiac effusion which requires treatment 4)Have another active malignancy 5)Currently have or have a history of hemoptysis, or hemosputum as defined below; a) continue hemosputum for more than one week b) have had or require continuous oral administration of hemostat c) have had or require injectable administration of hemostat 6)Have possibly complication related to bleeding episode a) Have a bleeding diathesis b) Have a evidence of involvement in major thoracic blood vassel c) Have a evidence of cavitation in intra-thoracic lesion d) Have a evidence of thrombosis 7)Have anti-thrombosis drugs within 10 days before enrollment or need them during the study 8)Currently have or have a history of the below disease; a) Currently have brain vascular disease with symptom, or have a history of it within one year before enrollment b) Have ever had a history of gastrointestinal perforation or diverticulitis or fistula c) Have symptomatic heart failure, unstable angina or arrhythmia which requires treatment, or have a history of cardiac infarction within one year before enrollment d) Have any evidence of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis or pulmonary fibrosis on chest X-ray or with clinically active symptom, or have medical history of it e) Currently have superior vena cava syndrome f) Currently have a cord compression g) Have a serious, nonhealing wound or unhealed bone fracture. h) Have an uncontrollable ulcer i) Have uncontrollable hypertension j) Have a serious concomitant active infection, which needs antibiotics, antimycotic drugs or virucide 9)have a known sensitivity to any component of platinum drugs or monoclonal antibody drugs 10)Not have time interval described after prior therapies at the time of study entry ...etc.
研究者
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