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Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC) (DeLLphi-315)

2026年9月16日 更新者：Amgen

A Phase 3, Open-Label, Multicenter, Randomized Study of Subcutaneous vs Intravenous Tarlatamab in Participants With Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-315)

The primary objective of this study is to demonstrate non-inferiority in pharmacokinetic (PK) parameters of subcutaneous (SC) vs intravenous (IV) tarlatamab administration and to characterize the efficacy, safety, and tolerability of SC tarlatamab in participants with relapsed extensive-stage small-cell lung cancer (ES-SCLC) after platinum-based chemotherapy.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

400

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
      • Shanghai、中国、200433
        • 招聘中
        • Shanghai Pulmonary Hospital
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100142
        • 招聘中
        • Beijing Cancer Hospital
      • Beijing、Beijing Municipality、中国、100020
        • 招聘中
        • Beijing Chaoyang Hospital
  • 日本
    • Tokyo
      • Bunkyo-ku、Tokyo、日本、113-8677
        • 招聘中
        • Tokyo Metropolitan Komagome Hospital
  • 澳大利亚
    • South Australia
      • Elizabeth Vale、South Australia、澳大利亚、5112
        • 招聘中
        • Lyell McEwin Hospital
  • 瑞士
      • Zurich、瑞士、8091
        • 招聘中
        • Universitaetsspital Zuerich
  • 美国
    • Florida
      • Orlando、Florida、美国、32806
        • 招聘中
        • University of Florida Health Cancer Center at Orlando Health
    • Michigan
      • Grand Rapids、Michigan、美国、49503
        • 招聘中
        • Cancer and Hematology Centers of Western Michigan
    • Nebraska
      • Omaha、Nebraska、美国、68130
        • 招聘中
        • Oncology Hematology West PC

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Participant has provided informed consent prior to initiation of any study specific activities/procedures.
  • Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
  • Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
  • Participants who progressed or recurred following 1 platinum-based regimen.
  • Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
  • Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
  • Minimum life expectancy of 12 weeks.
  • Adequate organ function.
  • History of central nervous system (CNS) metastases are allowed with considerations defined in the protocol.

Exclusion Criteria:

Disease Related

- Any previous diagnosis of non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation that has transformed to SCLC, or mixed SCLC and NSCLC histology, with exceptions defined in the protocol.

Other Medical Conditions

  • Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment.
  • History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
  • Current evidence or history of non-infectious pneumonitis/ILD (interstitial lung disease) that required steroids or other immunosuppressive treatment.
  • History of other malignancy within the past 2 years, with exceptions defined in the protocol.
  • Presence or history of viral infection based on criteria per protocol.
  • History of solid organ transplantation.
  • Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
  • Known sensitivity or a contraindication to any of the products or components.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.

Prior/Concomitant Therapy

  • Prior systemic anticancer therapy within 30 days of enrolment
  • Prior history of severe or life-threatening events from any immune-mediated therapy.
  • Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment.
  • Live and live-attenuated vaccines within 28 days prior to the start of study treatment.
  • Receiving another anticancer therapy for a malignancy other than SCLC.
  • More than 1 prior line of anticancer therapy for SCLC.
  • Participation in a tarlatamab clinical trial or prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
  • Treatment in an alternative investigational trial within 28 days prior to enrolment.
  • History of allergy or hypersensitivity to similar products (eg, drugs with a similar chemical structure or other monoclonal antibody) or any excipient.

Other Exclusions

  • Participants unable to have SC injections administered in the abdomen or thigh.
  • Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements.
  • History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Tarlatamab SC
Participants will receive Tarlatamab via SC injection
药品：Tarlatamab
Administered via SC injection or IV infusion
其他名称：
  • AMG 757
  • IMDELLTRA
有源比较器：Tarlatamab IV
Participants will receive Tarlatamab via IV infusion
药品：Tarlatamab
Administered via SC injection or IV infusion
其他名称：
  • AMG 757
  • IMDELLTRA

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Area Under the Curve From Cycle 2 Day 1 to Day 15 (AUC C2D1-D15) of Tarlatamab
大体时间：From Cycle 2 Day 1 to Day 15 (each cycle is 28 days)
From Cycle 2 Day 1 to Day 15 (each cycle is 28 days)
Predose Concentration (Ctrough) of Tarlatamab
大体时间：On Cycle 2 Day 15 (each cycle is 28 days)
On Cycle 2 Day 15 (each cycle is 28 days)

次要结果测量

结果测量
大体时间
总生存期（OS）
大体时间：最长约 4 年
最长约 4 年
对患者报告的不良事件调查问卷 (PRO-CTCAE) 的答复
大体时间：最长约 4 年
最长约 4 年
Objective response (OR) per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
大体时间：Up to approximately 4 years
Up to approximately 4 years
Progression free survival (PFS) per RECIST v1.1
大体时间：Up to approximately 4 years
Up to approximately 4 years
Duration of response (DOR) per RECIST v1.1
大体时间：Up to approximately 4 years
Up to approximately 4 years
Disease control (DC) per RECIST v1.1
大体时间：Up to approximately 4 years
Up to approximately 4 years
Number of participants with treatment-emergent adverse events (TEAEs) and Treatment-related Adverse Events (TRAEs)
大体时间：Up to approximately 4 years
Up to approximately 4 years
Change from Baseline in Visual Analogue Scale (VAS) score of the EuroQol5 Dimension (EQ-5D-5L)
大体时间：Up to approximately 4 years
Up to approximately 4 years
Responses to Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire on symptom bother
大体时间：Up to approximately 4 years
Up to approximately 4 years
Responses to Therapy Administration Satisfaction Questionnaire (TASQ)
大体时间：Up to approximately 4 years
Up to approximately 4 years
Number of Participants with Anti-tarlatamab Antibody Formation
大体时间：Up to approximately 4 years
Up to approximately 4 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Amgen

调查人员

  • 研究主任：MD、Amgen

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月28日

初级完成 (估计的)

2027年9月24日

研究完成 (估计的)

2030年7月30日

研究注册日期

首次提交

2026年8月12日

首先提交符合 QC 标准的

2026年8月20日

首次发布 (实际的)

2026年8月21日

研究记录更新

最后更新发布 (实际的)

2026年9月17日

上次提交的符合 QC 标准的更新

2026年9月16日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 20250046

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD 共享时间框架

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD 共享访问标准

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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