JPRN-jRCT2080224085已完成2 期
Randomized phase II study of osimertinib plus ramucirumab and osimertinib for chemotherapy-naive patients with nonsquamous non-small cell lung cancer harboring EGFR mutations - TORG1833
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
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) Histological or cytological diagnosis of non-squamous non-small-cell lung cancer
- •2) Histological or cytological evidence of EGFR mutation (exon 19 deletion or L858R)
- •3) Stage IIIB, IIIC or IV disease not treatable with radical radiotherapy, or postoperative recurrent disease (UICC-TNM Classification, 8th edition)
- •4) No symptomatic brain metastasis. Brain metastasis is acceptable if neurological recovery (CTCAE v4.0 Grade 0-1 or equivalent) following radiation treatment has been maintained for at least 2 weeks before enrollment
- •5) Aged 20 years or older at the time of informed consent
- •6) ECOG performance status (PS): 0 or 1
- •7) Has measurable lesion(s) as defined in the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, excluding irradiated lesions
- •8) Previously untreated with drug therapy for lung cancer (including EGFR-TKIs and immune checkpoint inhibitors), excluding preoperative or postoperative chemotherapy completed at least 6 months before enrollment in the study
- •9) No severe damage to major organs and satisfying the specified criteria
- •10) Female patients of childbearing potential must have a negative urine or serum pregnancy test within 14 days prior to first dose of protocol therapy.
- •11) Has given written informed consent to participate in the study after receiving detailed explanation of the study before enrollment in the study.
排除标准
- •1) Known T790M EGFR mutation
- •2) Active double cancer (synchronous double cancer or metachronous double cancer with a 5-year or shorter disease-free period, excluding lesions such as carcinoma in situ and intramucosal carcinoma)
- •3) The patient has a history of gross hemoptysis (defined as the presence of >= 1/2 teaspoon of gross blood) within 2 months prior to enrollment.
- •4) The patient has radiographic evidence of intratumor cavitation, regardless of tumor histology.
- •5) Likely to have any concurrent disease associated with bleeding
- •6) The patient is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted.
- •7) Active infection
- •8) The patient is pregnant or breast-feeding, reject contraception.
- •9) SPO2 < 94% (room air)
- •10) Clinically significant psychiatric disease
- •11) Requiring continuous systemic steroid therapy at a prednisolone equivalent dose higher than10 mg/day or receiving an immunosuppressant
- •12) History of serious hypersensitivity to osimertinib or ramucirumab
- •13) Active hepatic impairment (HBs antigen positive, HBV-DNA positive, alcoholic hepatitis, autoimmune hepatitis, liver cirrhosis)
- •14) Symptomatic cerebrovascular disease, interstitial lung disease or other complications, or a history of gastrointestinal perforation, thromboembolism, etc.
- •15) Orally receiving CYP3A4 inducers (phenytoin, rifampicin, carbamazepine, St.John,s wort)
- •16) Inappropriate for the study, in the opinion of the investigator, etc.
研究者
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