NL-OMON44906已完成不适用
A multi-center, open-label study to assess the safety and efficacy of combination ceritinib (LDK378) and nivolumab in adult patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (CLDK378A2120C) - CLDK378A2120C
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 3
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 64（—）
入选标准
- •* Female and male patients * 18 years of age.
- •* Relapsed locally advanced or metastatic NSCLC with an ALK-rearrangement.
- •* Measurable disease.
- •* Clinically and neurologically stable CNS metastases who have not required increasing doses of steroids or stable doses > 10 mg daily prednisone equivalent within 2 weeks prior to study entry to manage CNS symptoms.
- •* In the expansion phase, patients must have received prior treatment according to the following: Arm 1: ALK inhibitor-treated, ALK inhibitor: Yes, Chemotherapy: 0 or 1 prior courses, Prior treatment with any ALK inhibitor except ceritinib is allowed.
- •Arm 2: ALK inhibitor-naïve ALK inhibitor: No, Chemotherapy: 0 or 1 prior courses.
- •* WHO performance status 0 or 1.
排除标准
- •* Severe hypersensitivity reactions to other monoclonal antibodies.
- •* Prior treatment with anti-PD1/anti-PD-L1 agents.
- •* Chronic systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of treatment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted to enroll in the absence of active autoimmune disease.
- •* Clinically significant, uncontrolled heart disease and/or recent cardiac event. See protocol page 14 for details.
- •* (History of) interstitial lung disease.
- •* Comedications listed on page 14 of the protocol.
- •* Pregnancy, lactation, inadequate contraception (males and females). See protocol page 15 for details.
研究者
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