What is obrixtamig studying for advanced small cell lung cancer?

Obrixtamig is being studied to see if adding it to standard treatment improves survival for adults with advanced small cell lung cancer. The study also evaluates a device that measures a tumour marker called DLL3. This research is sponsored by Boehringer Ingelheim and aims to better understand treatment options for this condition.

Who may be eligible for this advanced small cell lung cancer clinical trial?

Adults 18 years or older with confirmed extensive-stage small cell lung cancer may be eligible. Participants should not have had prior systemic treatment for this stage and must be able to receive standard chemotherapy with atezolizumab, carboplatin, and etoposide. The trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced small cell lung cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation needs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07472517

DAREON 4-Lung-1 A Phase III Randomized Trial Comparing Intravenous Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Versus Standard Chemotherapy in Advanced Small Cell Lung Cancer

Led by Boehringer Ingelheim · Updated on 2026-06-02

670

Participants Needed

236

Research Sites

46 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating treatments for adults with advanced small cell lung cancer SCLC to see if adding a study medicine called obrixtamig to standard therapy improves survival compared to standard treatment alone. Obrixtamig is an antibody-like molecule designed to help the immune system fight cancer. The study also tests a new medical device to measure a tumour marker called DLL3 as part of the evaluation. Participants are randomly assigned to one of two groups one receives obrixtamig plus the standard treatment of atezolizumab, carboplatin, and etoposide, while the other group receives only the standard treatment. All treatments are given through infusions into a vein. Those receiving obrixtamig stay overnight at the study site after the first two doses. This phase III trial compares outcomes between these groups to assess treatment effects. Participants remain in the study for up to three years, with regular visits to the study site. Doctors monitor tumour size and overall health, watch for side effects, and record any unwanted reactions. The main measurement is overall survival over 36 months. Other assessments include progression-free survival, symptom changes, response rates, and safety events. This extensive monitoring helps researchers understand the treatments impact and safety.

CONDITIONS

Brief Title

DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemotherapy

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Histologically confirmed extensive-stage small cell lung cancer (ES-SCLC)
No prior systemic anti-cancer treatment for ES-SCLC; previous limited-stage treatment allowed if completed over 6 months before ES-SCLC diagnosis
Adequate tumour tissue available for DLL3 biomarker analysis
Asymptomatic brain metastases allowed if stable and meeting specific treatment timing criteria
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Eligible for first-line standard treatment with carboplatin, etoposide, and atezolizumab within 28 days after starting initial therapy
Able to receive full doses of atezolizumab, carboplatin, and etoposide as per approved guidelines

You will not qualify if you...

Presence of leptomeningeal disease or carcinomatous meningitis
Prior treatment targeting DLL3 including T cell engagers, cell therapies, antibody-drug conjugates, or radiopharmaceuticals
Radiotherapy to any site within 14 days before randomisation
Unresolved toxicity from previous treatments above Grade 1 (with some exceptions)
Active autoimmune disease requiring systemic treatment or history of such disease, except certain controlled conditions
Other specific exclusion criteria as per study protocol

Research Team

Boehringer Ingelheim

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