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Clinical Trials in the UK / NCT07472517
Recruiting Phase 3

DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemoimmunotherapy

NCT07472517 · tracked via the Priya Life Science UK tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 3
Started
2026-04-13
Last updated
2026-09-15

Condition(s) studied

Small Cell Lung Cancer (SCLC)Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Investigational drug(s) / intervention(s)

obrixtamigatezolizumabcarboplatinetoposide

obrixtamig: obrixtamig

atezolizumab: atezolizumab

carboplatin: carboplatin

etoposide: etoposide

Study summary

This study is open to adults with advanced small cell lung cancer (SCLC). The purpose of this study is to find out if a study medicine called obrixtamig plus standard treatment (atezolizumab, carboplatin, and etoposide) improves survival when compared to standard treatment alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker DLL3.

Participants are put into 2 groups randomly, which means by chance. One group receives obrixtamig and standard treatment. The other group receives standard treatment without obrixtamig. All treatments are given as infusions into a vein.

Participants are in the study for up to 3 years. During this time, they visit the study site regularly. Participants in the group receiving obrixtamig stay overnight at the study site following the first 2 obrixtamig treatments. At the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria : 1. Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC) 2. Patients without any previous systemic anti-cancer treatment for ES-SCLC. Patients who received previous systemic anti-cancer treatment during limited stage are eligible if the treatment has been completed more than 6 months before the diagnosis of ES-SCLC. 3. Adequate archival formalin-fixed paraffin-embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status and other biomarkers. The central laboratory investigational VENTANA DLL3 (SP347) RxDx test result must be available prior to randomisation. 4. Patients with asymptomatic brain metastasis are eligible if they meet one of the following criteria: * Treatment for brain metastases (e.g. whole brain radiation therapy, stereotactic radiotherapy, or radiosurgery) completed at least 7 days prior to randomisation and the patient is neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 7 days prior to randomisation * Untreated brain metastases that do not require treatment and the patient is neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 28 days prior to randomisation 5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 6. Eligible for continuing carboplatin + etoposide + atezolizumab regimen as first-line Standard of care (SoC) treatment within 28 days after the start of the initial cycle of standard therapy 7. Eligible to receive treatment with full dose of atezolizumab, carboplatin, and etoposide as first-line SoC treatment, in accordance with the approved Summary of Product Characteristics if provided centrally or approved local product label if provided by the trial site Further inclusion criteria apply. Exclusion Criteria : 1. Presence of leptomeningeal disease and/or carcinomatous meningitis 2. Previous treatment targeting DLL3 (e.g. T cell engagers (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals) 3. Radiotherapy of any anatomical site within 7 days prior to randomisation 4. Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline. Patients with alopecia, any grade, CTCAE ≤Grade 2, asthenia/fatigue, amenorrhea/menstrual disorders any grade, CTCAE Grade ≤2 peripheral neuropathy, and/or CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks prior to randomisation, per investigator judgment may be eligible. Note: Patients who developed toxicity from the cycle of standard therapy received prior to randomisation are eligible if adequate organ function is ensured as described 5. Patient with active autoimmune disease or a documented history of autoimmune disease that requires systemic treatment (e.g. glucocorticoids or immunosuppressive drugs). Patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy, patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen may be included if in the opinion of the investigator it is appropriate and safe to do so. Further exclusion criteria apply.

Primary outcome measure(s)

Trial sites (245)

FacilityCityRegionStatus
Infirmary Cancer Care Mobile Alabama Not Yet Recruiting
University of Arkansas for Medical Sciences Little Rock Arkansas Not Yet Recruiting
Bioresearch Partner - Hialeah Hospital Hialeah Florida Recruiting
Emory University Atlanta Georgia Recruiting
Norton Cancer Institute, Downtown Louisville Kentucky Recruiting
Pikeville Medical Center Pikeville Kentucky Not Yet Recruiting
Epic Medical Research - Monroe Monroe Louisiana Not Yet Recruiting
Ochsner Medical Center New Orleans Louisiana Not Yet Recruiting
Epic Medical Research - Shreveport Shreveport Louisiana Not Yet Recruiting
University of Maryland School of Medicine Baltimore Maryland Recruiting
Veterans Affairs Ann Arbor Healthcare System Ann Arbor Michigan Not Yet Recruiting
HCA MidAmerica Division, Inc. Kansas City Missouri Recruiting
University of Nebraska Medical Center Omaha Nebraska Not Yet Recruiting
Cape Fear Valley Cancer Center Fayetteville North Carolina Not Yet Recruiting
AHN Cancer Institute - Allegheny General Pittsburgh Pennsylvania Recruiting
Baptist Cancer Center - Memphis Memphis Tennessee Recruiting
University of Wisconsin Madison Wisconsin Not Yet Recruiting
Hospital Britanico de Buenos Aires CABA Argentina Recruiting
Clinica Adventista Belgrano CABA Argentina Recruiting
Clinica Privada Independencia Munro Argentina Recruiting
Sanatorio Allende S.A. Nueva Córdoba Argentina Recruiting
Sanatorio Parque S.A. Rosario Argentina Recruiting
Prince of Wales Hospital-Randwick-66496 Randwick New South Wales Recruiting
Cancer Research South Australia Adelaide South Australia Recruiting
Ballarat Regional Integrated Cancer Centre Ballarat Victoria Recruiting
Hospital Elisabethinen Linz Linz Austria Not Yet Recruiting
Johannes Kepler University Linz Linz Austria Not Yet Recruiting
Standort Penzing der Klinik Ottakring Vienna Austria Not Yet Recruiting
Centre Hospitalier Interrégional Edith Cavell (CHIREC) Brussels Belgium Not Yet Recruiting
Universitair Ziekenhuis Antwerpen Edegem Belgium Not Yet Recruiting
Universitair Ziekenhuis Brussel Jette Belgium Not Yet Recruiting
UZ Leuven Leuven Belgium Not Yet Recruiting
Hospital de Amor Barretos Brazil Recruiting
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa Sociedade Simples Porto Alegre Brazil Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre Porto Alegre - RS Brazil Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto Brazil Recruiting
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd. Panagyurishte Bulgaria Not Yet Recruiting
MHAT Heart and brain Pleven Bulgaria Not Yet Recruiting
Acibadem City Clinic Tokuda University Hospital EAD Sofia Bulgaria Not Yet Recruiting
Verspeeten Family Cancer Centre (LHSC) London Ontario Not Yet Recruiting

+ 205 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07472517 on ClinicalTrials.gov ↗ ← All trials in the UK