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
18 Years and older, Male and Female
1438-0012 (primary)
NCI-2026-04564
2025-520565-51-00
U1111-1317-4955
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
- Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC)
- 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.
- 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.
- 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
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- 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
- 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.
Treatment Sites in Georgia
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