NL-OMON54228招募中2 期
A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects with Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-301) - 20200491 - DeLLphi-301
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Amgen
- 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 99（—）
入选标准
- •o Male and female subjects (>= 18 years of age) at the time of signing the
- •inform consent
- •o Histologically or cytologically confirmed relapsed/refractory SCLC
- •o Subject who progressed or recurred following 1 platinum-based regimen and at
- •least 1 other prior line of therapy
- •(Note: [1] re-treatment with a platinum-based regimen is considered a second
- •line of therapy; [2] platinum-based regimen followed by checkpoint
- •inhibitor/anti-programmed death ligand 1 [PD-L1] as maintenance therapy is
- •considered 1 line of therapy; [3] in countries where standard of care first
- •line systemic treatment includes platinum
- •containing chemotherapy in combination with PD-L1 inhibitor, it is required
- •that subjects have failed PD-L1 inhibitor as part of their first line systemic
- •treatment or are ineligible to receive PDL1 inhibitor therapy.
- •For more information, see section 5.1 of the protocol.
排除标准
- •- Untreated or symptomatic brain metastases and leptomeningeal disease.
- •- Has evidence of interstitial lung disease or active, non-infectious
- •pneumonitis.
- •- Subjects who experienced recurrent pneumonitis (grade 2 or higher) or severe,
- •life-threatening immune-mediated adverse events or infusion-related reactions
- •including those that lead to permanent discontinuation while on treatment with
- •immuno-oncology agents.
- •- Unresolved toxicity from prior anti-tumor therapy, defined as not having
- •resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
- •grade 1, or to levels dictated in the eligibility criteria with the exception
- •of alopecia or toxicities from prior anti-tumor therapy that are considered
- •irreversible (defined as having been present and stable for > 21 day) which may
- •be allowed if they are not otherwise described in the exclusion criteria AND
- •there is agreement to allow by both the investigator and Amgen.
- •For more information, see section 5.2 of the protocol.
研究者
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