JPRN-jRCTs041210103招募中2 期
Randomized, open label phase II study of brigatinib, carboplatin plus pemetrexed and brigatinib for chemotherapy-naive patients with ALK-rearranged non-squamous non-small cell lung cancer (WJOG14720L)
Hirotsugu Kenmotsu0 个研究点目标入组 110 人开始时间: 2021年11月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
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 obtained from the patient
- •2.Aged at least 20 years at the time of informed consent
- •3.Histologically or cytologically confirmed non-squamous non-small cell lung cancer
- •4.Confirmed ALK rearrangement by companion diagnostics
- •5.Stage IIIB, stage IIIC, stage IV, or postoperative relapse for which definitive radiotherapy is impossible
- •6.At least 1 measurable lesion based on RECIST v1.1
- •7.No symptomatic brain metastases
- •8.No symptomatic superior vena cava syndrome
- •9.No spinal cord compression
- •10.Patients with non-squamous non-small cell lung cancer previously untreated with chemotherapy
- •11.The specified time period has elapsed since the treatment defined in protocol
- •12.ECOG PS 0-1
- •13.Adequate organ function
排除标准
- •1.Presence of active double cancers
- •2.Presence of active systemic infection or topical infection requiring surgical treatment
- •3.Presence of active hepatitis B or C
- •4.Pregnancy or Lactation in women
- •5.Men who do not intend to use contraception
- •6.Presence of symptomatic cerebrovascular diseases or past history of these within 1 year
- •7.Nausea, vomiting, or absorption impediments causing difficulty with administration of the trial drug
- •8.Presence of congestive heart failure and unstable angina or past history of myocardial infarction within 1 year
- •9.History of interstitial lung disease, drug-induced interstitial lung disease, and radiation pneumonitis requiring steroid treatment
- •10.Presence of psychiatric disorder or mental symptoms
- •11.Calculated based on prednisone, requiring continuous full-body administration of high-dosage steroids over 10 mg/day or currently using other immunosuppressant drugs
- •12.History of hypersensitivity to brigatinib, carboplatin, pemetrexed and any excipients of these drugs
- •13.Other patients determined unfit by an attending physician will also be excluded.
研究者
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