DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer

Conditions

• Small Cell Lung Carcinoma (SCLC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BI 764532 — DRUG
  BI 764532
• Carboplatin — DRUG
  Carboplatin
• Etoposide — DRUG
  Etoposide
• Atezolizumab — DRUG
  Atezolizumab

Study Details

This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that are eligible for standard of care including chemotherapy and anti-PD-L1 (Programmed Cell Death Ligand 1) immunotherapy. The purpose of this study is to find out the highest dose of BI 764532 (also called obrixtamig) that people can tolerate when taken together with standard of care. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. Participants get BI 764532 and different standard treatments as infusions into a vein. If there is benefit for the participants and if they can tolerate it, the treatment is given for the entire duration of the study. During this time, participants visit the study site regularly. The visits also depend on the response to the treatment. At the study visits, the doctors check the health of the participants, take necessary laboratory tests, and note any health problems that could have been caused by the study treatment.

Key Dates

Start date

Feb 14, 2024

Status verified

Jun 2026

Primary completion

Sep 1, 2026

Completion

Apr 1, 2027

Study Design

Enrollment

46 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part A - Dose escalation: BI 764532 very low dose + carboplatin + etoposide + atezolizumab
• Experimental: Part A - Dose escalation: BI 764532 low dose + carboplatin + etoposide + atezolizumab
• Experimental: Part A - Dose escalation: BI 764532 medium dose + carboplatin + etoposide + atezolizumab
• Experimental: Part A - Dose escalation: BI 764532 high dose + carboplatin + etoposide + atezolizumab
• Experimental: Part B - Dose expansion: BI 764532 + carboplatin + etoposide + atezolizumab

Primary Outcome Measure

Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period [ Time Frame: up to 6 weeks ]

Locations (2)

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