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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 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Australien
    • New South Wales
      • Camperdown, New South Wales, Australien, 2050
  • Belgien
      • Edegem, Belgien, 2650
      • Ghent, Belgien, 9000
  • China
      • Nanning, China, 530021
        • The Affiliated Cancer Hospital, Guangxi Medical University
        • Kontakt:
      • Shanghai, China, 200030
      • Shanghai, China, 200433
  • Deutschland
      • Mainz, Deutschland, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • Kontakt:
      • Stuttgart, Deutschland, 70376
        • Robert Bosch Gesellschaft für medizinische Forschung mbH
        • Kontakt:
  • Frankreich
      • Lyon, Frankreich, 69373
      • Marseille, Frankreich, 13385
      • Villejuif, Frankreich, 94800
  • Japan
      • Hokkaido, Sapporo, Japan, 003-0804
      • Kanagawa, Kawasaki, Japan, 216-8511
        • St. Marianna University Hospital
        • Kontakt:
      • Osaka, Hirakata, Japan, 573-1191
        • Kansai Medical University Hospital
        • Kontakt:
      • Shizuoka, Sunto-gun, Japan, 411-8777
  • Niederlande
      • Amsterdam, Niederlande, 1081HV
  • Polen
      • Brzozów, Polen, 36-200
        • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza
        • Kontakt:
      • Wroclaw, Polen, 53439
  • Spanien
      • L'Hospitalet Del Llobregat, Spanien, 08908
      • Madrid, Spanien, 28041
        • Hospital Universitario 12 de Octubre
        • Kontakt:
      • Valencia, Spanien, 46010
        • Hospital Clinico De Valencia (INCLIVA)
        • Kontakt:
  • Vereinigte Staaten
    • District of Columbia
      • Washington D.C., District of Columbia, Vereinigte Staaten, 20007
    • Florida
      • Tampa, Florida, Vereinigte Staaten, 33612
    • Kentucky
      • Lexington, Kentucky, Vereinigte Staaten, 40536
  • Vereinigtes Königreich
      • Leicester, Vereinigtes Königreich, LE1 5WW
      • Newcastle upon Tyne, Vereinigtes Königreich, NE7 7DN

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Part 1: obrixtamig + ZL-1310 (dosing regimen 1)
Arzneimittel: Obrixtamig
Obrixtamig
Arzneimittel: ZL-1310
ZL-1310
Experimental: Part 1: obrixtamig + ZL-1310 (dosing regimen 2)
Arzneimittel: Obrixtamig
Obrixtamig
Arzneimittel: ZL-1310
ZL-1310
Experimental: Part 2: obrixtamig + ZL-1310 + atezolizumab
Arzneimittel: Atezolizumab
Atezolizumab
Arzneimittel: Obrixtamig
Obrixtamig
Arzneimittel: ZL-1310
ZL-1310

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Part 1: The occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period
Zeitfenster: 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
Zeitfenster: Up to 24 months.
Up to 24 months.
Part 2: PFS rate at 6 months
Zeitfenster: 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.

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Boehringer Ingelheim

Mitarbeiter

Zai Lab

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

29. September 2026

Primärer Abschluss (Geschätzt)

26. April 2030

Studienabschluss (Geschätzt)

26. April 2030

Studienanmeldedaten

Zuerst eingereicht

13. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Juli 2026

Zuerst gepostet (Tatsächlich)

16. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

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-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • SAFT
  • ICF
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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