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

NCT07707895 | Not Yet Recruiting Phase 1 FDA Drug

• 3 other identifiers: 1438-0036U1111-1334-01482026-525634-27
• Study Type: interventional
• Target: 60
• Locations: 11 countries
• Sites: 26

Brief Summary

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.

Conditions

Small Cell Lung Cancer; Large Cell Neuroendocrine Lung Carcinoma; Extrapulmonary Neuroendocrine Carcinoma of Small Cell Histology; Extrapulmonary Neuroendocrine Carcinoma of Large Cell Histology

Outcome Measures

Primary Outcomes (3)

• Part 1: The occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period

  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

  Up to 24 months.

• Part 2: PFS rate 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.

Secondary Outcomes (8)

• Part 1 and Part 2: Occurrence of treatment-emergent DLTs

  Up to 24 months.

• Part 1 and Part 2: Occurrence of treatment-emergent adverse event of special interest (AESIs)

  Up to 24 months.

• Part 1 and Part 2: Occurrence of treatment-emergent AEs CTCAE Grade ≥3

  Up to 24 months.

• Part 1 and Part 2: Objective response (OR)

  Up to 24 months.

• Part 1 and Part 2: Duration of response (DoR)

  Up to 24 months.

Study Arms (3)

Part 1: obrixtamig + ZL-1310 (dosing regimen 1)

EXPERIMENTAL

Drug: Obrixtamig; Drug: ZL-1310

Part 1: obrixtamig + ZL-1310 (dosing regimen 2)

EXPERIMENTAL

Drug: Obrixtamig; Drug: ZL-1310

Part 2: obrixtamig + ZL-1310 + atezolizumab

EXPERIMENTAL

Drug: Obrixtamig; Drug: ZL-1310; Drug: Atezolizumab

Interventions

Obrixtamig DRUG

Obrixtamig

Part 1: obrixtamig + ZL-1310 (dosing regimen 1); Part 1: obrixtamig + ZL-1310 (dosing regimen 2); Part 2: obrixtamig + ZL-1310 + atezolizumab

ZL-1310 DRUG

ZL-1310

Part 1: obrixtamig + ZL-1310 (dosing regimen 1); Part 1: obrixtamig + ZL-1310 (dosing regimen 2); Part 2: obrixtamig + ZL-1310 + atezolizumab

Atezolizumab DRUG

Atezolizumab

Part 2: obrixtamig + ZL-1310 + atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Part 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
• 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
• 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
• 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.
• 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
• 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
• 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)
• 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

You may not qualify if:

• 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
• Patients with a diagnosis of Merkel cell carcinoma or medullary thyroid cancer
• Presence of leptomeningeal disease and/or carcinomatous meningitis
• 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
• 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
• 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)
• 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.
• Prior organ or tissue allograft

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Zai Lab: collaborator

Study Sites (26)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Chris Obrien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

The Affiliated Cancer Hospital, Guangxi Medical University

Nanning, 530021, China

Location

Shanghai Chest Hospital

Shanghai, 200030, China

Location

Shanghai Pulmonary Hospital

Shanghai, 200433, China

Location

CTR Leon Berard

Lyon, 69373, France

Location

HOP Timone

Marseille, 13385, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Robert Bosch Gesellschaft für medizinische Forschung mbH

Stuttgart, 70376, Germany

Location

Hokkaido Cancer Center

Hokkaido, Sapporo, 003-0804, Japan

Location

St. Marianna University Hospital

Kanagawa, Kawasaki, 216-8511, Japan

Location

Kansai Medical University Hospital

Osaka, Hirakata, 573-1191, Japan

Location

Shizuoka Cancer Center

Shizuoka, Sunto-gun, 411-8777, Japan

Location

Amsterdam UMC Locatie VUMC

Amsterdam, 1081HV, Netherlands

Location

Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza

Brzozów, 36-200, Poland

Location

Lower Silesian Oncology Centre

Wroclaw, 53439, Poland

Location

Hospital Duran i Reynals

L'Hospitalet Del Llobregat, 08908, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clinico De Valencia (INCLIVA)

Valencia, 46010, Spain

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start (Estimated): August 26, 2026
• Primary Completion (Estimated): April 26, 2030
• Study Completion (Estimated): April 26, 2030
• Last Updated: August 5, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: 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.
• Access Criteria: 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.

Locations

ES (3); BE (2); GB (3); PL (2); JP (4); CN (3); AU (1); US (2); FR (3); DE (2); NL (1)