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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. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
  • Belgia
      • Edegem, Belgia, 2650
      • Ghent, Belgia, 9000
  • Forente stater
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20007
    • Florida
      • Tampa, Florida, Forente stater, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
        • Ta kontakt med:
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40536
  • Frankrike
      • Lyon, Frankrike, 69373
      • Marseille, Frankrike, 13385
      • Villejuif, Frankrike, 94800
  • Japan
      • Hokkaido, Sapporo, Japan, 003-0804
      • Kanagawa, Kawasaki, Japan, 216-8511
        • St. Marianna University Hospital
        • Ta kontakt med:
      • Osaka, Hirakata, Japan, 573-1191
        • Kansai Medical University Hospital
        • Ta kontakt med:
      • Shizuoka, Sunto-gun, Japan, 411-8777
  • Kina
      • Nanning, Kina, 530021
        • The Affiliated Cancer Hospital, Guangxi Medical University
        • Ta kontakt med:
      • Shanghai, Kina, 200030
        • Shanghai Chest Hospital
        • Ta kontakt med:
      • Shanghai, Kina, 200433
        • Shanghai Pulmonary Hospital
        • Ta kontakt med:
  • Nederland
      • Amsterdam, Nederland, 1081HV
  • Polen
      • Brzozów, Polen, 36-200
        • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza
        • Ta kontakt med:
      • Wroclaw, Polen, 53439
        • Lower Silesian Oncology Centre
        • Ta kontakt med:
  • Spania
      • L'Hospitalet Del Llobregat, Spania, 08908
      • Madrid, Spania, 28041
        • Hospital Universitario 12 de Octubre
        • Ta kontakt med:
      • Valencia, Spania, 46010
        • Hospital Clinico De Valencia (INCLIVA)
        • Ta kontakt med:
  • Storbritannia
      • Leicester, Storbritannia, LE1 5WW
      • Newcastle upon Tyne, Storbritannia, NE7 7DN
  • Tyskland
      • Mainz, Tyskland, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • Ta kontakt med:
      • Stuttgart, Tyskland, 70376
        • Robert Bosch Gesellschaft für medizinische Forschung mbH
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Part 1: obrixtamig + ZL-1310 (dosing regimen 1)
Legemiddel: Obrixtamig
Obrixtamig
Legemiddel: ZL-1310
ZL-1310
Eksperimentell: Part 1: obrixtamig + ZL-1310 (dosing regimen 2)
Legemiddel: Obrixtamig
Obrixtamig
Legemiddel: ZL-1310
ZL-1310
Eksperimentell: Part 2: obrixtamig + ZL-1310 + atezolizumab
Legemiddel: Atezolizumab
Atezolizumab
Legemiddel: Obrixtamig
Obrixtamig
Legemiddel: ZL-1310
ZL-1310

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Part 1: The occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period
Tidsramme: 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
Tidsramme: Up to 24 months.
Up to 24 months.
Part 2: PFS rate at 6 months
Tidsramme: 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.

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Samarbeidspartnere

Zai Lab

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

29. september 2026

Primær fullføring (Antatt)

26. april 2030

Studiet fullført (Antatt)

26. april 2030

Datoer for studieregistrering

Først innsendt

13. juli 2026

Først innsendt som oppfylte QC-kriteriene

13. juli 2026

Først lagt ut (Faktiske)

16. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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