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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

StatusRecruiting
PhasePhase 3
Started2025-11-07
View on ClinicalTrials.gov ↗

Amendment history

2026-09-30
minor
Start date moved earlier: 2026-04-13 → 2025-11-07
2026-08-18
minor
Study Status, Contacts/Locations v13
Study sites244→245
2026-08-14
minor
Study Identification, Study Status, Eligibility, Contacts/Locations v12
Study sites242→244
Eligibility criteria+249 characters
[...] ll Cell Lung Cancer (ES-SCLC) Patients without any previous systematicsystemic anti-cancer treatment for ES-SCLC. Patients who received previous systematicsystemic anti-cancer treatment during limited stage are eligible if [...] reotactic radiotherapy, or radiosurgery) completed at least 147 days prior to randomisation and the patient is neurologically stable without the use of glucocorticoids or [...] ntreated brain metastases that do not require treatment and arethe patient is neurologically stable without the use of glucocorticoids or [...] es, or radiopharmaceuticals) Radiotherapy of any anatomical sitessite [...] [...]
Study title+6 characters
[...] lizumab, Carboplatin, and Etoposide Treatment With Standard ChemotherapyChemoimmunotherapy
2026-08-05
minor
Study Status, Contacts/Locations v11
Study sites242 entries, revised
Wuhan Union Hospital Tongji Medical College Huazhong University of Science and Technology
2026-07-20
minor
Study Status, Contacts/Locations v10
Study sites241→242
2026-07-06
minor
Study Status, Contacts/Locations v9
Trial sites expanded: 237 → 241 locations
2026-06-22
minor
Study Status, Contacts/Locations v8
Study sites236→237
2026-06-08
minor
Study Status, Contacts/Locations v7
Study sitesdetails revised at 5 of 236 sites
2026-06-01
minor
Study Status, Contacts/Locations v6
Study sites235→236
2026-05-28
minor
Study Status, Contacts/Locations v5
Trial sites expanded: 232 → 235 locations
2026-05-11
minor
Study Status, Contacts/Locations v4
Study sites232 entries, revised
INSEpic CancérologieMedical deResearch l'Ouest- Monroe
2026-04-27
minor
Study Status, Contacts/Locations v3
Study sites232 entries, revised
ClevelandCentro ClinicOncologico Estatal ISSEMyM "Dr. Jose Luis Barrera Franco"
2026-04-15
notable
Study Status, Contacts/Locations v2
Recruitment opened
Trial sites expanded: 229 → 232 locations
Primary completion date2028-09-10→2028-09-09
Completion date2029-07-31→2029-07-30
Start dateestimated 2026-04-10→confirmed 2026-04-13
2026-03-30
minor
Study Status, Contacts/Locations v1
Completion pushed: 2029-04-16 → 2029-07-31
Study sites228→229
2026-03-13
minor
Original filing
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.
Trial Details
NCT Number NCT07472517
Lead Sponsor Boehringer Ingelheim
Conditions Small Cell Lung Cancer (SCLC), Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Enrollment 670 participants
Start Date 2025-11-07
Primary Completion 2028-09-09 (estimated)
Study Completion 2029-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-29