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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

31 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • Fase 2
  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Alemania
      • Mainz, Alemania, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • Contacto:
      • Stuttgart, Alemania, 70376
        • Robert Bosch Gesellschaft für medizinische Forschung mbH
        • Contacto:
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
  • Bélgica
      • Edegem, Bélgica, 2650
        • Universitair Ziekenhuis Antwerpen
        • Contacto:
      • Ghent, Bélgica, 9000
        • Universitair Ziekenhuis Gent
        • Contacto:
  • España
      • L'Hospitalet Del Llobregat, España, 08908
        • Hospital Duran i Reynals
        • Contacto:
      • Madrid, España, 28041
        • Hospital Universitario 12 de Octubre
        • Contacto:
      • Valencia, España, 46010
        • Hospital Clinico De Valencia (INCLIVA)
        • Contacto:
  • Estados Unidos
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20007
        • MedStar Georgetown University Hospital
        • Contacto:
    • Florida
      • Tampa, Florida, Estados Unidos, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
        • Contacto:
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40536
        • University of Kentucky Medical Center
        • Contacto:
  • Francia
      • Lyon, Francia, 69373
        • CTR Leon Berard
        • Contacto:
      • Marseille, Francia, 13385
      • Villejuif, Francia, 94800
        • Institut Gustave Roussy
        • Contacto:
  • Japón
      • Hokkaido, Sapporo, Japón, 003-0804
        • Hokkaido Cancer Center
        • Contacto:
      • Kanagawa, Kawasaki, Japón, 216-8511
        • St. Marianna University Hospital
        • Contacto:
      • Osaka, Hirakata, Japón, 573-1191
        • Kansai Medical University Hospital
        • Contacto:
      • Shizuoka, Sunto-gun, Japón, 411-8777
        • Shizuoka Cancer Center
        • Contacto:
  • Países Bajos
      • Amsterdam, Países Bajos, 1081HV
        • Amsterdam UMC locatie Vumc
        • Contacto:
  • Polonia
      • Brzozów, Polonia, 36-200
        • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza
        • Contacto:
      • Wroclaw, Polonia, 53439
        • Lower Silesian Oncology Centre
        • Contacto:
  • Porcelana
      • Nanning, Porcelana, 530021
        • The Affiliated Cancer Hospital, Guangxi Medical University
        • Contacto:
      • Shanghai, Porcelana, 200030
        • Shanghai Chest Hospital
        • Contacto:
      • Shanghai, Porcelana, 200433
        • Shanghai Pulmonary Hospital
        • Contacto:
  • Reino Unido
      • Leicester, Reino Unido, LE1 5WW
      • Newcastle upon Tyne, Reino Unido, NE7 7DN

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Part 1: obrixtamig + ZL-1310 (dosing regimen 1)
Droga: Obrixtamig
Obrixtamig
Droga: ZL-1310
ZL-1310
Experimental: Part 1: obrixtamig + ZL-1310 (dosing regimen 2)
Droga: Obrixtamig
Obrixtamig
Droga: ZL-1310
ZL-1310
Experimental: Part 2: obrixtamig + ZL-1310 + atezolizumab
Droga: Atezolizumab
Atezolizumab
Droga: Obrixtamig
Obrixtamig
Droga: ZL-1310
ZL-1310

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part 1: The occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period
Periodo de tiempo: 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
Periodo de tiempo: Up to 24 months.
Up to 24 months.
Part 2: PFS rate at 6 months
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part 1 and Part 2: Occurrence of treatment-emergent DLTs
Periodo de tiempo: Up to 24 months.
Up to 24 months.
Part 1 and Part 2: Occurrence of treatment-emergent adverse event of special interest (AESIs)
Periodo de tiempo: Up to 24 months.
Up to 24 months.
Part 1 and Part 2: Occurrence of treatment-emergent AEs CTCAE Grade ≥3
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 6 weeks from the first administration of study medication.
6 weeks from the first administration of study medication.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Boehringer Ingelheim

Colaboradores

Zai Lab

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

29 de septiembre de 2026

Finalización primaria (Estimado)

26 de abril de 2030

Finalización del estudio (Estimado)

26 de abril de 2030

Fechas de registro del estudio

Enviado por primera vez

13 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

13 de julio de 2026

Publicado por primera vez (Actual)

16 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

31 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1438-0036
  • U1111-1334-0148 (Identificador de registro: WHO International Clinical Trials Registry Platform (ICTRP))
  • 2026-525634-27 (Identificador de registro: CTIS)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Marco de tiempo para compartir IPD

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.

Criterios de acceso compartido de IPD

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.

Tipo de información de apoyo para compartir IPD

  • SAVIA
  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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