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Obrixtamig with atezolizumab, carboplatin, and etoposide for advanced small cell lung cancer

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

Phase 3 Interventional Boehringer Ingelheim · NCT07472517

This trial will test whether adding obrixtamig to atezolizumab plus carboplatin and etoposide helps people with extensive-stage small cell lung cancer live longer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment670 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Drugs / interventionsatezolizumab, radiation
Locations232 sites (Mobile, Alabama and 231 other locations)
Trial IDNCT07472517 on ClinicalTrials.gov

What this trial studies

Adults with extensive-stage small cell lung cancer are randomly assigned to receive standard treatment (atezolizumab with carboplatin and etoposide) with or without obrixtamig, and all drugs are given by intravenous infusion. The study requires available tumour tissue for central DLL3 testing before randomization and uses a device being developed to measure DLL3 levels. Participants are followed for up to three years with regular site visits and imaging to monitor tumour response and safety. Patients receiving obrixtamig stay overnight after the first two infusions as part of monitoring for early reactions.

Who should consider this trial

Good fit: Adults with histologically confirmed extensive-stage small cell lung cancer who have not received prior systemic therapy for ES-SCLC and who can provide adequate tumour tissue for central DLL3 testing are eligible.

Not a fit: Patients who have already received systemic treatment for extensive-stage disease, who cannot provide suitable tumour tissue for DLL3 testing, or who do not meet the brain metastasis stability criteria are unlikely to benefit from joining this trial.

Why it matters

Potential benefit: If successful, adding obrixtamig could extend survival or improve disease control compared with current standard therapy.

How similar studies have performed: Immunotherapy plus chemotherapy is an established option for ES-SCLC, but DLL3-targeted approaches are relatively new and prior DLL3-directed agents have shown mixed results, so this combination remains investigational.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria :

1. Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC)
2. Patients without any previous systematic anti-cancer treatment for ES-SCLC. Patients who received previous systematic 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 14 days prior to randomisation and 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 are 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 sites within 14 days prior to randomisation
4. 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 prior to randomisation, per investigator judgment)
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.

Where this trial is running

Mobile, Alabama and 231 other locations

+182 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Small Cell Lung CancerExtensive-stage Small Cell Lung Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.