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DAREON™-5: BI 764532 for Small Cell Lung Cancer and Other Neuroendocrine Cancers

This study is for adults with advanced small cell lung cancer or other neuroendocrine cancers where previous treatments haven't worked or there are no standard options. It aims to find a safe and effective dose of BI 764532 (also called obrixtamig), a drug designed to help your immune system fight cancer. Researchers will test two different doses of BI 764532 to see if it can shrink tumors and what side effects might occur. Success would mean tumors shrinking. The study involves 204 participants, and you would be randomly assigned to one of two groups.

Study design
This study is interventional and involves 204 participants. In Part 1, participants are randomly assigned to one of two groups to receive different doses of BI 764532.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track how well the treatment works and any side effects for up to 26 or 27 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05882058

DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers

Recruiting
PHASE2Ages 18+InterventionalTreatment
Boehringer Ingelheim
~204 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:BI 764532, dose 1BI 764532, dose 2Ventana DLL3 RxDx assay

At a glance

Recruiting sites
37 of 59 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR)
Measured over up to 26 months
+4 more outcomes measured

Conditions

Small Cell Lung Carcinoma
Neuroendocrine Neoplasms
Extra-pulmonary Neuroendocrine Carcinoma

Explore related trials

Extrapulmonary Neuroendocrine CarcinomaLarge Cell Neuroendocrine CarcinomaLung Small Cell Carcinoma

Where it's being run

59 sites across 23 states
Japan7
China6
Germany6
Spain5
United Kingdom4
Florida3
France3
South Korea3

Who to contact

Boehringer Ingelheim
[email protected]
1-800-243-0127
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Small cell lung cancer (SCLC)
Extra-pulmonary neuroendocrine carcinoma (epNEC) (except Merkel cell carcinoma (MCC), Medullary thyroid cancer (MTC) and Neuroendocrine prostate cancer (NEPC))
Large cell neuroendocrine carcinoma (LCNEC) of the lung Patients with tumours with mixed histologies for any above type are eligible only if the neuroendocrine carcinoma/small tumour cells component is predominant and represents at least 50% of the overall tumour tissue.
SCLC: after at least two prior lines of therapy, including at least one platinum-based regimen; in countries where standard of care in first line therapy includes PD-L1 inhibitor treatment patients should have received the combination of platinum-based regimen plus PD-L1 inhibitor unless they have been unable to receive checkpoint inhibitor treatment.
Therapy includes PD-L1 inhibitor treatment; patients should have received the combination of platinum-based regimen plus PD-L1 inhibitor unless they have been unable to receive checkpoint inhibitor treatment.
epNEC/LCNEC: after at least one platinum-based regimen. Part 2 and part 3: Histologically or cytologically confirmed epNEC (except MCC, MTC and NEPC) with centrally assessed DLL3 high expression status. Patients must have progressed or recurred after at least one platinum-based regimen. 4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1., 5. Measurable lesions as defined per Response Evaluation Criteria In Solid Tumours (RECIST) v 1.1 within 21 days prior to the first dose of BI 764532. 6. Part 1: Availability of archival tumour tissue sample Part 2 and part 3: Availability of archival formalin-fixed paraffin-embedded (FFPE) tumour tissue sample. Following specimens are not allowed: Fine Needle Aspiration (FNA), Cytology samples, decalcified bone samples. 7. Adequate organ function as defined in the protocol. 8. All toxicities related to previous anti-cancer therapies have resolved = Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to trial treatment administration (except for alopecia, peripheral neuropathy, fatigue and endocrinopathies controlled by replacement therapy which must be = CTCAE Grade 2 and amenorrhea/menstrual disorders which can be any grade). 9. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information 10. Only for Part 3, at the timepoint of Screening 02:
For Cycle 1, patients should be willing to stay within 1 hour driving distance for 48 hours after IMP administration and confirm availability of a caregiver for the same timeframe.
Patients should be considered suitable by the investigator to follow instructions applicable to the reduced monitoring cohort, such as taking their temperature and administration of oral medication at home if needed.

Exclusion

Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 764532.
Patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant central nervous system (CNS) disease. 2. Presence of leptomeningeal disease or, part 2 and part 3: epidural disease including spinal cord compression. 3. Part 1: Active/previous history of interstitial lung disease or non-infectious pneumonitis (any grade).
Patients who have been treated with any other anti-cancer drug within 4 weeks or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532.
Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532. 6. Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers or cell therapies. 7. Diagnosis of immunodeficiency or systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of BI 764532. Physiological replacement of steroids is allowed.

What this trial measures

  • Part 1: Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR)up to 26 months

    according to RECIST v 1.1 by investigator assessment from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.

  • Part 1: Occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment periodup to 26 months
  • Part 2: Objective response (OR)up to 27 months

    Objective response is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v 1.1 by blinded independent central review from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent

  • Part 3: Occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment periodup to 23 months
  • Part 3: Objective response (OR) by blinded independent central reviewup to 23 months