NL-OMON49812已完成2 期
Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non*Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib - Takeda 2002
ARIAD Pharmaceuticals, Inc. a wholly owned subsidiary of Takeda Pharmaceutical Company Limited0 个研究点目标入组 4 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
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
- 18 至 99（—）
入选标准
- •1. Have histologically or cytologically confirmed stage IIIB (locally advanced
- •or recurrent and not a candidate for curative therapy) or stage IV NSCLC.
- •2. Must meet both of the following 2 criteria:
- •a) Have documentation of ALK rearrangement by a positive result from any
- •laboratory test approved by the Food and Drug Administration (FDA) (eg, the
- •Vysis ALK Break Apart FISH [fluorescence in situ hybridization] Probe Kit or
- •the Ventana ALK [D5F3] CDx [companion diagnostic] Assay or Foundation
- •Medicine*s FoundationOne CDx)
- •Have documented ALK rearrangement by a different test (non*FDA-approved local
- •lab tests) and have provided tumor sample to the central laboratory (Note:
- •Central laboratory ALK rearrangement testing results are not required to be
- •obtained before randomization.)
- •b) The patient had been treated with any 1 of the ALK tyrosine kinase
- •inhibitors (TKIs) (alectinib, ceritinib, crizotinib) for at least 12 weeks
- •before progression.
- •3. Had progressive disease while on alectinib or ceritinib (defined as no more
- •than 1 month from last dose of alectinib or ceritinib to disease progression,
- •as assessed by the investigator or treating physician). (Number of patients not
- •previously treated with alectinib will be capped at 10 for every 30 patients
- •4. Had alectinib or ceritinib as the most recent ALK inhibitor therapy.
- •Chemotherapy before or after progression on alectinib or ceritinib is allowed.
- •5. Have at least 1 measurable lesion per RECIST version 1.1 as assessed by the
- •investigator.
- •6. Recovered from toxicities related to prior anticancer therapy to National
- •Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
- •Grade *1. (Note: Treatment-related alopecia or peripheral neuropathy that are
- •Grade >1 are allowed if deemed irreversible.)
- •7. Have Eastern Cooperative Oncology Group performance status *1.
- •8. Have adequate organ and hematologic function.
排除标准
- •1. Received any prior ALK-targeted TKI other than crizotinib, alectinib, or
- •2. Received both alectinib and ceritinib.
- •3. Received crizotinib, alectinib, or ceritinib within 7 days of the first dose
- •of brigatinib.
- •4. Previously received more than 3 regimens of systemic anticancer therapy for
- •locally advanced or metastatic disease.
- •Note: A systemic anticancer therapy regimen will be counted if it is
- •administered for at least 1 complete cycle. A new anticancer agent used as
- •maintenance therapy will be counted as a new regimen. Neo-adjuvant or adjuvant
- •systemic anticancer therapy will be counted as a prior regimen if disease
- •progression/recurrence occurred within 12 months upon completion of this
- •(neo-)adjuvant therapy.
- •5. Have symptomatic brain metastasis (parenchymal or leptomeningeal). Patients
- •with asymptomatic brain metastasis or who have stable symptoms that did not
- •require an increased dose of corticosteroids to control symptoms in the past 7
- •days before the first dose of brigatinib may be enrolled.
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