NCT07472517Recruiting
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
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.
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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, Estonia, Finland, Georgia, Greece, Hong Kong, Hungary, Ireland, Japan, Latvia, Malaysia, Mexico, Moldova, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Vietnam
- Sponsor
- Boehringer Ingelheim(Industry)
- Protocol no.
- 1438-0012
- Conditions
- Small Cell Lung Cancer (SCLC), Extensive-stage Small Cell Lung Cancer (ES-SCLC)
- Interventions
- Drug
Treatments studied
- obrixtamig
- atezolizumab
- carboplatin
- etoposide
Locations · 157
- Bordeaux, FranceINS BergonieRecruiting at this site
- Caen, FranceCTR François BaclesseRecruiting at this site
- Nantes, FranceHOP Nord LaennecRecruiting at this site
- Paris, FranceINS CurieRecruiting at this site
- Paris, FranceHôpital CochinRecruiting at this site
- Villefranche-sur-Saône, FranceHOP Villefranche-sur-SaôneRecruiting at this site
- Aachen, GermanyUniversitätsklinikum Aachen, AöRRecruiting at this site
- Berlin-Spandau, GermanyVivantes Klinikum SpandauRecruiting at this site
- Dresden, GermanyTechnische Universität DresdenRecruiting at this site
- Frankfurt, GermanyUniversitätsklinikum FrankfurtRecruiting at this site
- Gauting, GermanyAsklepios Fachkliniken München-GautingRecruiting at this site
- Hamburg, GermanyAsklepios Kliniken GmbH & Co. KGaARecruiting at this site
- Heidelberg, GermanyThoraxklinik-Heidelberg gGmbH am Universitätsklinikum HeidelbergRecruiting at this site
- Oldenburg, GermanyPius-Hospital, OldenburgRecruiting at this site
- Würzburg, GermanyUniversitätsklinikum Würzburg AÖRRecruiting at this site
- Meldola (FC), ItalyIstituto Scientifico RomagnoloRecruiting at this site
- Roma, ItalyFondazione Policlinico Universitario Campus Bio-medicoRecruiting at this site
- Verona, ItalyAzienda Ospedaliera Universitaria Integrata VeronaRecruiting at this site
- Linz, AustriaHospital Elisabethinen LinzRecruiting at this site
- Linz, AustriaJohannes Kepler University LinzRecruiting at this site
- Hialeah, United StatesBioresearch Partner - Hialeah HospitalRecruiting at this site
- Atlanta, United StatesEmory UniversityRecruiting at this site
- Louisville, United StatesNorton Cancer Institute, DowntownRecruiting at this site
- Monroe, United StatesEpic Medical Research - MonroeRecruiting at this site
- Shreveport, United StatesEpic Medical Research - ShreveportRecruiting at this site
- Baltimore, United StatesUniversity of Maryland School of MedicineRecruiting at this site
- Kansas City, United StatesHCA MidAmerica Division, Inc.Recruiting at this site
- Omaha, United StatesUniversity of Nebraska Medical CenterRecruiting at this site
- Fayetteville, United StatesCape Fear Valley Cancer CenterRecruiting at this site
- Pittsburgh, United StatesAHN Cancer Institute - Allegheny GeneralRecruiting at this site
In total, worldwide, 157 of the 243 sites listed in the registry are recruiting; the other 86 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 28, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 127 more locations
Other identifiers
- 2025-520565-51-00 · other registry
- U1111-1317-4955 · other registry
- 2025 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.