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

Conditions

• Extensive-stage Small Cell Lung Cancer (ES-SCLC)
• Small Cell Lung Cancer (SCLC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• obrixtamig — DRUG
  obrixtamig
• atezolizumab — DRUG
  atezolizumab
• carboplatin — DRUG
  carboplatin
• etoposide — DRUG
  etoposide

Study Details

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.

Key Dates

Start date

Apr 13, 2026

Status verified

Jun 2026

Primary completion

Sep 9, 2028

Completion

Jul 30, 2029

Study Design

Enrollment

670 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: obrixtamig + atezolizumab, carboplatin, and etoposide treatment arm
• Experimental: atezolizumab, carboplatin, and etoposide control arm

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Up to 36 months ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (14)

Find similar trials in Mobile, AL

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