NL-OMON49613已完成2 期
A randomized, open label, multicenter phase II study evaluating the efficacy and safety of capmatinib (INC280) plus pembrolizumab versus pembrolizumab alone as first line treatment for locally advanced or metastatic non-small cell lung cancer with PD-L1* 50% - CINC280I12201
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 5
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
- •* Males or females * 18 years of age.
- •* Histologically confirmed locally advanced stage III (not candidates for
- •surgical resection or definitive chemo-radiation) or stage IV (metastatic)
- •NSCLC for treatment in the first-line setting. See protocol chapter 5.1 item 3
- •for further details.
- •* Both EGFR wild type status and ALK-negative rearrangement status. See
- •protocol chapter 5.1 item 4 for further details.
- •* Archival tumor sample or newly obtained tumor biopsy with high PD-L1
- •expression (TPS * 50%) at screening. See protocol chapter 5.1 item 5 for
- •further details.
- •* ECOG performance status of 0 or 1.
- •* At least one measurable lesion. See protocol chapter 5.1 item 7 for further
- •* Adequate organ function. See protocol paragraph 5.1 item 9 for details
排除标准
- •* Prior treatment with a MET inhibitor or HGF-targeting therapy.
- •* Prior immunotherapy. See protocol paragraph 5.2 item 2 for details.
- •* History of severe hypersensitivity reactions to other monoclonal antibodies.
- •* Untreated symptomatic CNS metastases, see protocol paragraph 5.2 item 5 for
- •* Presence or history of interstitial lung disease or interstitial pneumonitis,
- •including clinically significant radiation pneumonitis (i.e. affecting
- •activities of daily living or requiring therapeutic intervention).
- •* Clinically significant, uncontrolled heart disease, see protocol paragraph
- •5.2, item 8.
- •* Concomitant medication(s) with a *Known Risk of Torsades de Point (TdP)* per
- •www.qtdrugs.org that cannot be discontinued or replaced.
- •* Treatment with strong inducers of CYP3A4 that cannot be discontinued at least
- •1 week prior to the start of treatment with capmatinib and for the duration of
- •* Systemic chronic steroid therapy (>10 mg/day prednisone or equivalent) or any
- •immunosuppressive therapy 7 days prior to planned date of first dose of study
- •treatment, see protocol paragraph 5.2 item 14 for details.
- •* Live vaccination within 4 weeks prior to first dose of study drug.
- •* Active, known or suspected autoimmune disease or documented history, see
- •protocol paragraph 5.2 item 20 for details.
- •* Pregnant or lactating women, females of childbearing potential not using
- •adequate contraception and males not using adequate contraception. See protocol
- •paragraph 5.2 item 22-24 for details.
研究者
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