JPRN-jRCTs031180056已完成3 期
Randomized phase III study comparing erlotinib plus bevacizumab to erlotinib alone in patients with previously untreated non-small cell lung cancer harboring EGFR mutation - (NEJ026)
Maemondo Makoto0 个研究点目标入组 228 人开始时间: 2018年12月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 228
研究概览
简要总结
Combination therapy with bevacizumab and erlotinib has thus been validated as one of the standard treatments for patients with EGFR mutation-positive NSCLC.
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)Histologically or cytologically documented non-squamous NSCLC
- •(2)EGFR (Exon 19 deletion or Exon 21 L858R) mutation status, detected with PCR, is active
- •(3)Stage IIIB or stage IV or recurrent NSCLC
- •(4)No prior systemic chemotherapy. Patients with history of treatment with anticancer drugs for pleurodesis are not eligible. If patients have received neoadjuvant / adjuvant chemotherapy, the patients who experience recurrence after 6 months are permitted
- •(5)Regarding the patients who have be treated withradiotherapy;
- •1)Not have received radiotherapy to lesions of lung
- •2)More than 2 weeks after receiving radiotherapy to lesions except lung
- •(6)Regarding the patients who have be treated with therapy as follows;
- •1)More than 4 weeks after the last operation
- •2)More than 2 weeks after the last pleurodesis except anticancer drugs
- •3)More than 2 weeks after the last biopsy with an incision
- •4)More than 2 weeks after the last treatment for injury
- •5)More than 2 weeks after the last blood transfusion
- •6)More than 4 weeks after the last administration of other investigational drugs
- •(7)Patients who have at least one or more measurable lesion by RESIST (Version1.1)
- •(8)Aged >=20, at the time of consent
- •(9)ECOG PS 0-2
- •(10)Have adequate organ function as follows;
- •1)neutrophil >=1,500/mm3
- •2)hemoglobin >=9.0g/dL
- •3)platelet >=100,000/mm3
- •4)bilirubin <=1.5mg/dL
- •5)AST/ALT <=2.5xULN
- •6)serum creatinine <=1.5mg/dL
- •7)PaO2(room air) >=70Torr or SpO2 >=94%
- •8)APTT <=ULN
- •9)PT-INR <=1.5
- •10)urine protein under 1+
- •(11)Written informed consent
- •(12)Estimated life expectancy at least 3 months
排除标准
- •(1)Exon 20 T790M mutation status, detected with PCR, is active. Have received
- •(2)Have symptomatic brain metastasis
- •(3)Have a history of multiple malignancies within 5 years
- •(4)History of pulmonary hemorrhage or hemoptysis as defined below;
- •1)Hemosputum continuing for more than 1 week within 1 year before enrollment.
- •2)Have had or require continuous oral administration of hemostat
- •3)Have had or require injectable administration of hemostat
- •(5)Evidence of bleeding diathesis or hemoptysis
- •(6)Evidence of tumor invading a perihilar blood vessel or cavitation in intra-thoracic lesion on imaging
- •(7)Evidence of tumor invading segmental bronchus
- •(8)Uncontrolled pleural, ascites effusion or cardiac effusion
- •(9)Having a history or serious complications as bellows;
- •1)SVC syndrome complication
- •2)Spinal cord compression
- •3)Having a history of serious symptomatic cerebrovascular disease within 1 year before enrollment
- •4)Unrecovered fracture or severe injury
- •5)Systemic treatment of steroid for more than 4 weeks
- •6)Have severe infection
- •7)Having a history or evidence of ILD complication on imaging or lung infection (except history of radiation pneumonitis in radiation area)
- •8)Have gastrointestinal dysfunction as follows;
- •<1>Impossible to take drugs orally
- •<2>Need intravenous feeding
- •<3>Have malabsorption by surgery
- •<4>Have active peptic ulcer
- •9)Have severe corneal disease complication
- •10)Have severe heart disease complication
- •11)Have diverticulitis
- •12)Have ever had a history of gastrointestinal perforation within 1 year prior to registration
- •13)Have severe neurological deficit or mental disorder
- •14)Have active hepatic disease
- •(10)Surgery planned in trial period
- •(11)Have a history of severe allergy of other monoclonal antibody drugs
- •(12)Have a history of EGFR TKI or anti-angiogenesis drug administration
- •(13)Pregnant or breast-feeding woman
- •(14)Patients who have no will to contraception
- •(15)Patients whose participation in the trial is judged to be inappropriate by the doctor
研究者
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