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ALK陽性非小細胞肺癌患者におけるLDK378(アレクチニブによる治療歴あり)。
基本情報
- NCT ID
- NCT02450903
- ステータス
- 完了
- 試験のフェーズ
- 第2相
- 試験タイプ
- 介入
- 目標被験者数
- 20
- 治験依頼者名
- Novartis
概要
This was a single-arm, open-label, multicenter, phase II study to evaluate the efficacy and safety of the ALK inhibitor LDK378 when used as single agent in patients with ALK-rearranged stage IIIB or IV NSCLC previously treated with alectinib. Treatment with LDK378 750 mg qd continued until the patient experienced disease progression as determined by the investigator according to RECIST 1.1, unacceptable toxicity that precluded further treatment, pregnancy, start of a new anticancer therapy, discontinued treatment at the discretion of the patient or investigator, lost to follow-up, death, or study was terminated by Sponsor.
対象疾患
Non-Small-Cell Lung Cancer
介入
LDK378(DRUG)
依頼者(Sponsor)
ノバルティスファーマ株式会社(INDUSTRY)