NCT07472517From ClinicalTrials.govRecruiting

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

DAREON ® -Lung-1: A Phase III Multi-center, Open-label, Randomised Trial of Intravenous Obrixtamig in Combination With Atezolizumab, Carboplatin, and Etoposide vs. Atezolizumab, Carboplatin, and Etoposide as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer

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

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Boehringer Ingelheim
Enrolment target: 670
Started: 7 November 2025
Main results due: 9 September 2028
Study sites: 245
Registry updated: 29 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(245)

Infirmary Cancer Care
Mobile, Alabama, United States
Not yet recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Not yet recruiting
Bioresearch Partner - Hialeah Hospital
Hialeah, Florida, United States
Recruiting
Emory University
Atlanta, Georgia, United States
Recruiting
Norton Cancer Institute, Downtown
Louisville, Kentucky, United States
Recruiting
Pikeville Medical Center
Pikeville, Kentucky, United States
Not yet recruiting
Epic Medical Research - Monroe
Monroe, Louisiana, United States
Not yet recruiting
Ochsner Medical Center
New Orleans, Louisiana, United States
Not yet recruiting
Epic Medical Research - Shreveport
Shreveport, Louisiana, United States
Not yet recruiting
University of Maryland School of Medicine
Baltimore, Maryland, United States
Recruiting
Veterans Affairs Ann Arbor Healthcare System
Ann Arbor, Michigan, United States
Not yet recruiting
HCA MidAmerica Division, Inc.
Kansas City, Missouri, United States
Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, United States
Recruiting
Cape Fear Valley Cancer Center
Fayetteville, North Carolina, United States
Not yet recruiting
AHN Cancer Institute - Allegheny General
Pittsburgh, Pennsylvania, United States
Recruiting
Baptist Cancer Center - Memphis
Memphis, Tennessee, United States
Recruiting
University of Wisconsin
Madison, Wisconsin, United States
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, Australia
Recruiting
Cancer Research South Australia
Adelaide, South Australia, Australia
Recruiting
Ballarat Regional Integrated Cancer Centre
Ballarat, Victoria, Australia
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
Fundaçao Faculdade Regional de Medicina de Sao Jose 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, Canada
Not yet recruiting
Sault Area Hospital
Sault Ste. Marie, Ontario, Canada
Not yet recruiting
Icegclinic
La Florida, Chile
Not yet recruiting
Clinica Santa Maria
Providencia, Chile
Not yet recruiting
Instituto Oncologico FALP
Providencia, Chile
Not yet recruiting
Bradford Hill- Centro de Investigacion Clinica
Recoleta, Chile
Not yet recruiting
Clinica Alemana de Santiago S.A.
Santiago, Chile
Not yet recruiting
Beijing Cancer Hospital
Beijing, China
Not yet recruiting
Beijing Chest Hospital, Capital Medical University
Beijing, China
Recruiting
The First Affiliated Hospital Of Bengbu Medical College
Bengbu, China
Recruiting
Hunan Province Tumor Hospital
Changsha, China
Not yet recruiting
Sichuan Cancer Hospital
Chengdu, China
Recruiting
West China Hospital, Sichuan University
Chengdu, China
Recruiting
Fujian Cancer Hospital
Fuzhou, China
Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, China
Recruiting
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, China
Recruiting
The First Affiliated Hospital, Zhejiang University
Hangzhou, China
Not yet recruiting
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, China
Recruiting
Harbin Medical University Cancer Hospital
Harbin, China
Not yet recruiting
Shandong Cancer Hospital
Jinan, China
Recruiting
Linyi Cancer Hospital
Linyi, China
Recruiting

Showing 60 of 245 sites — filter to narrow it down. 134 of the 245 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07472517. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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