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DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers

2026年8月31日 更新者：Boehringer Ingelheim

A Phase Ib/II, Open-label, Safety and Tolerability Trial of Obrixtamig in Combination With ZL-1310 in Patients With Poorly Differentiated NEC

This study is open to adults with advanced small cell lung cancer and other neuroendocrine cancers. The study has 2 parts. The purpose of Part 1 is to find a suitable dose of a combination study treatment, obrixtamig and ZL-1310. The purpose of Part 2 is to see how obrixtamig and ZL-1310 is tolerated when given with another medicine called a checkpoint inhibitor. Another purpose is to check whether the study treatment can stop the cancer from growing and keep it stable. Obrixtamig and ZL-1310 are being developed to help the immune system fight cancer.

In Part 1, participants get obrixtamig and ZL-1310. In Part 2, participants get obrixtamig and ZL-1310 with a checkpoint inhibitor. Part 2 is only open to people with advanced small cell lung cancer. All study treatments are given as infusions into a vein.

The study does not have a fixed duration. Participants can receive study treatment for up to 2 years if they benefit from treatment and can tolerate it. Participants visit the study site regularly, with some overnight stays required. During this time, doctors regularly check for health problems that could be caused by the study treatment. They also monitor the size of the tumour(s) and take laboratory tests.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

60

阶段

  • 阶段2
  • 阶段1

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
      • Nanning、中国、530021
        • The Affiliated Cancer Hospital, Guangxi Medical University
        • 接触：
      • Shanghai、中国、200030
      • Shanghai、中国、200433
        • Shanghai Pulmonary Hospital
        • 接触：
  • 德国
      • Mainz、德国、55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • 接触：
      • Stuttgart、德国、70376
        • Robert Bosch Gesellschaft für medizinische Forschung mbH
        • 接触：
  • 日本
      • Hokkaido, Sapporo、日本、003-0804
      • Kanagawa, Kawasaki、日本、216-8511
        • St. Marianna University Hospital
        • 接触：
      • Osaka, Hirakata、日本、573-1191
        • Kansai Medical University Hospital
        • 接触：
      • Shizuoka, Sunto-gun、日本、411-8777
  • 比利时
      • Edegem、比利时、2650
      • Ghent、比利时、9000
  • 法国
      • Lyon、法国、69373
      • Marseille、法国、13385
      • Villejuif、法国、94800
  • 波兰
      • Brzozów、波兰、36-200
        • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza
        • 接触：
      • Wroclaw、波兰、53439
        • Lower Silesian Oncology Centre
        • 接触：
  • 澳大利亚
    • New South Wales
      • Camperdown、New South Wales、澳大利亚、2050
  • 美国
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20007
    • Florida
      • Tampa、Florida、美国、33612
    • Kentucky
      • Lexington、Kentucky、美国、40536
  • 英国
  • 荷兰
      • Amsterdam、荷兰、1081HV
  • 西班牙
      • L'Hospitalet Del Llobregat、西班牙、08908
      • Madrid、西班牙、28041
        • Hospital Universitario 12 de Octubre
        • 接触：
      • Valencia、西班牙、46010
        • Hospital Clinico De Valencia (INCLIVA)
        • 接触：

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:

For Part 1

  1. Diagnosed with locally advanced, metastatic or relapsed cancer of the following histologies:

    • Small cell lung carcinoma (SCLC)
    • Large cell neuroendocrine lung carcinoma (LCNEC-L)
    • Extrapulmonary neuroendocrine carcinoma (epNEC) of small or large cell histology
  2. Patients with tumours with mixed histologies for any above type are eligible only if the neuroendocrine carcinoma/small cell component is predominant and represents at least 50% of the overall tumour tissue

  3. Patients for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. Patients must have exhausted available treatment options known to prolong survival for their disease. Previous therapies should include at least one line of platinum-based chemotherapy, unless there is a documented medical reason not to use platinum

    For Part 2

  4. Histologically or cytologically confirmed extended stage small cell lung cancer (ES-SCLC) (excluding combined histologies) using the American Joint Committee on Cancer (AJCC) tumour node metastasis staging system combined with Veterans Administration Lung Study Group (VALG)'s two stage classification scheme.

  5. Patients must have received no prior systemic therapy for ES-SCLC. Participants with prior chemoradiotherapy for Limited stage small cell lung cancer (LS-SCLC) must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible

    For both Part 1 and Part 2

  6. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses
  7. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF)
  8. Willing and able to comply with scheduled visits, treatment schedule, the planned trial assessments, laboratory tests, restrictions regarding prohibited medications, lifestyle restrictions, and other requirements related to the trial. This includes that they are able to understand and follow trial-related instructions
  9. Further inclusion criteria apply.

Exclusion criteria:

  1. Serious concomitant disease or medical condition such as neurologic, psychiatric (including substance use disorder), active ulcers (gastrointestinal tract or skin) or laboratory abnormalities that may negatively impact patient safety during trial participation, affect compliance with trial requirements or invalidate assessments relevant for the investigation of the safety and preliminary efficacy of the investigational drugs
  2. Patients with a diagnosis of Merkel cell carcinoma or medullary thyroid cancer
  3. Presence of leptomeningeal disease and/or carcinomatous meningitis
  4. Known hypersensitivity to the trial drugs or their excipients, prior severe, life-threatening hypersensitivity reaction(s) to monoclonal antibodies, or significant risk of allergic or anaphylactic reaction(s) to any of the investigated drug products according to the investigator's judgement
  5. Participants who experienced severe, life-threatening immune-mediated adverse events, e.g. serious Grade 3 or higher immune-related adverse event (imAE) or infusion-related reactions, that led to permanent discontinuation while on treatment with immuno-oncology agents
  6. Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia/fatigue, amenorrhea/menstrual disorders, CTCAE Grade 2 peripheral neuropathy, and CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per investigator judgment)
  7. Therapy with any of the following types of treatments or drugs within the noted time intervals prior to IMP administration: At any time: treatment with delta-like ligand 3 (DLL3)-targeting therapies or received more than 30 Gy of thoracic radiotherapy.
  8. Prior organ or tissue allograft
  9. Further exclusion criteria apply.

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：非随机化
  • 介入模型：顺序分配
  • 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：Part 1: obrixtamig + ZL-1310 (dosing regimen 1)
药品：奥布里克斯塔米格
奥布里克斯塔米格
药品：ZL-1310
ZL-1310
实验性的：Part 1: obrixtamig + ZL-1310 (dosing regimen 2)
药品：奥布里克斯塔米格
奥布里克斯塔米格
药品：ZL-1310
ZL-1310
实验性的：Part 2: obrixtamig + ZL-1310 + atezolizumab
药品：阿特珠单抗
阿特珠单抗
药品：奥布里克斯塔米格
奥布里克斯塔米格
药品：ZL-1310
ZL-1310

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Part 1: The occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period
大体时间：6 weeks from the first administration of study medication.
6 weeks from the first administration of study medication.
Part 2: The occurrence of treatment-emergent adverse events (AEs) leading to trial medication discontinuation or dose modification
大体时间：Up to 24 months.
Up to 24 months.
Part 2: PFS rate at 6 months
大体时间：At 6 months.
Progression-free survival (PFS) is defined as the time from first investigational medicinal product (IMP) administration until the earliest date of disease progression according to Response Evaluation Criteria In Solid Tumours (RECIST 1.1) based on investigator assessments or death from any cause, whichever occurs first.
At 6 months.

次要结果测量

结果测量
措施说明
大体时间
Part 1 and Part 2: Occurrence of treatment-emergent DLTs
大体时间：Up to 24 months.
Up to 24 months.
Part 1 and Part 2: Occurrence of treatment-emergent adverse event of special interest (AESIs)
大体时间：Up to 24 months.
Up to 24 months.
Part 1 and Part 2: Occurrence of treatment-emergent AEs CTCAE Grade ≥3
大体时间：Up to 24 months.
AEs CTCAE = Adverse events Common Terminology Criteria for Adverse Events
Up to 24 months.
Part 1 and Part 2: Objective response (OR)
大体时间：Up to 24 months.
OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 (based on investigator assessments) from the first IMP administration until the earliest date of disease progression, death, last evaluable tumour assessment before the start of the next line of anti-cancer treatment, loss to follow-up, or withdrawal of consent.
Up to 24 months.
Part 1 and Part 2: Duration of response (DoR)
大体时间：Up to 24 months.
DoR is defined as the time from the first documented objective response (OR) according to RECIST 1.1 until the earliest date of disease progression or death among patients with confirmed objective response based on investigator assessments.
Up to 24 months.
Part 1 and Part 2: Disease control (DC)
大体时间：Up to 24 months.
DC is defined as best overall response of complete response (CR) or partial response (PR) or stable disease (SD) where best overall response is defined according to RECIST version 1.1 based on investigator assessments from the first IMP administration until the earliest date of disease progression, death or last evaluable tumour assessment before start of the next line of anti-cancer treatment, loss to follow-up or withdrawal of consent.
Up to 24 months.
Part 1: Progression-free survival (PFS)
大体时间：Up to 24 months.
PFS is defined as the time from first IMP administration until the earliest date of disease progression according to RECIST 1.1 based on investigator assessments or death from any cause, whichever occurs first.
Up to 24 months.
Part 2: Occurrence of DLTs during the DLT evaluation period
大体时间：6 weeks from the first administration of study medication.
6 weeks from the first administration of study medication.

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

Boehringer Ingelheim

合作者

Zai Lab

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 (估计的)

2026年9月29日

初级完成 (估计的)

2030年4月26日

研究完成 (估计的)

2030年4月26日

研究注册日期

首次提交

2026年7月13日

首先提交符合 QC 标准的

2026年7月13日

首次发布 (实际的)

2026年7月16日

研究记录更新

最后更新发布 (实际的)

2026年9月2日

上次提交的符合 QC 标准的更新

2026年8月31日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1438-0036
  • U1111-1334-0148 (注册表标识符：WHO International Clinical Trials Registry Platform (ICTRP))
  • 2026-525634-27 (注册表标识符：CTIS)

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

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

IPD 共享时间框架

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD 共享访问标准

For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD 共享支持信息类型

  • 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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