Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase2

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

Sponsor: Boehringer Ingelheim

NCT ID: NCT05882058

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
BI 764532, dose 1 (drug), BI 764532, dose 2 (drug), Ventana DLL3 RxDx assay (device)
How long the study runs
Study runs about 56 months (dates as stated)
About the drug or intervention
BI 764532, dose 1 — drug: BI 764532, dose 1 · BI 764532, dose 2 — drug: BI 764532, dose 2 · Ventana DLL3 RxDx assay — device: Ventana DLL3 RxDx assay
Patient visit burden
Not specified by the sponsor

In plain English

This study tests different doses of a drug called BI 764532 in people with small cell lung cancer or other neuroendocrine cancers that have come back or worsened after standard treatment. The study is run by Boehringer Ingelheim and has three parts.

Who can take part

  • Adults aged 18 or over who agree in writing to take part
  • Have small cell lung cancer, extra-pulmonary neuroendocrine carcinoma, or large cell neuroendocrine carcinoma of the lung that has come back or worsened after standard treatment
  • For small cell lung cancer: already had at least two courses of treatment, including one with a platinum-based drug
  • For the other cancer types: already had at least one platinum-based treatment
  • Fairly well and active, with a performance (ECOG) score of 0 or 1
  • Have tumours that can be measured on scans
  • Able to provide a stored tumour tissue sample (some sample types are not allowed)
  • Good organ function, and side effects from earlier cancer treatment have mostly settled down
  • People who can become pregnant or father a child must use very reliable birth control
  • For Part 3 only: willing to stay within one hour's drive of the hospital for 48 hours after each dose, with a carer available, and able to follow instructions at home

Who may not be able to

  • Untreated or causing symptoms: brain metastases that have not been treated (treated and stable ones may be allowed)
  • Cancer in the lining of the brain or spinal cord, or spinal cord compression (Parts 2 and 3)
  • Current or past lung scarring or lung inflammation conditions (rules differ slightly by part)
  • Severe or life-threatening immune or infusion reactions to previous immunotherapy drugs
  • Recent other cancer treatment (within 4 weeks or 5 half-lives) or wide-area radiotherapy including whole brain radiotherapy within 2 weeks
  • Previous treatment targeting DLL3, including T cell engagers or cell therapies
  • Weakened immune system, or steroids or other immune-suppressing medicines within 7 days (replacement-level steroids are allowed)
  • Ongoing side effects from earlier cancer treatment beyond the limits described above
  • Further exclusion criteria apply - ask the trial team

What taking part involves

  • • Taking the study drug BI 764532 at different doses, depending on which part of the study you join
  • • Parts 2 and 3 require a brain MRI scan within 21 days before the first dose, and tumours tested for high levels of a marker called DLL3
  • • For Part 3, staying near the hospital and checking your temperature at home after doses

Time commitment: Not stated in full — the trial involves regular hospital visits for scans, tests and drug doses; details such as total duration and number of visits are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
204
Started
2023-10-13
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for small cell lung carcinoma
  • • Phase2 - 204 participants
  • • This study is open to adults with small cell lung cancer and other neuroendocrine tumours

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with small cell lung carcinoma

Where?

  • • Leicester - Leicester Royal Infirmary
  • • London - University College Hospital
  • • Manchester - The Christie Hospital
  • • Newcastle upon Tyne - Freeman Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This study is open to adults with small cell lung cancer and other neuroendocrine tumours. The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find a suitable dose of BI 764532 (also called obrixtamig) that people with advanced cancer can tolerate. 2 different doses of BI 764532 are tested in this study. Another purpose is to check whether BI 764532 can make tumours shrink. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. The study has 3 parts. In Part 1, participants are put into 2 groups randomly, which means by chance. Participants have an equal chance of being in either group. One group gets dose 1 of BI 764532 and the other group gets dose 2 of BI 764532. In Part 2 and Part 3, all participants receive the same dose of BI 764532. Part 2 and Part 3 are open to people with a certain kind of tumour called extrapulmonary neuroendocrine carcinoma. All participants receive BI 764532 as an infusion into a vein when starting treatment. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. The first study visits include an overnight stay to monitor participants´ safety. Doctors record any unwanted effects and regularly check the general health of the participants.

Small Cell Lung CarcinomaNeuroendocrine NeoplasmsExtra-pulmonary Neuroendocrine Carcinoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

PD-L1

Treatment history

Treatments you must have had:

  • ✓ progressed or recurred after standard of care therapy
  • ✓ progressed or recurred after at least one platinum-based regimen

What the study is looking for

  • ✓Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater...
  • ✓Signed and dated written agreement to take part in accordance with International Council for Harmonisation-Good Clinical...
  • ✓Part 1: confirmed by testing a sample, cancer of the following histologies:
  • ✓Small cell lung cancer (SCLC)
  • ✓Extra-lung neuroendocrine carcinoma (epNEC) (except Merkel cell carcinoma (MCC), Medullary thyroid cancer (MTC)...

Who cannot take part

  • ✗Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI...
  • ✗Presence of leptomeningeal disease or, part 2 and part 3: epidural disease including spinal cord compression.
  • ✗Part 1: Active/previous history of interstitial lung disease or non-infectious pneumonitis (any grade).
  • ✗Prior anti-cancer therapy:
  • ✗Patients who have been treated with any other anti-cancer drug within 4 weeks or within 5 half-life periods...
See the full criteria
Inclusion criteria: 1. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF). 2. Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. 3. Part 1: Histologically or cytologically confirmed, cancer of the following histologies: * 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. Patients must have progressed or recurred after standard of care therapy * 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 criteria: 1. Untreated or symptomatic brain metastases. (Part 2 and part 3: identified during the mandatory assessment by brain MRI within 21 days before first trial drug administration.) Participants with treated, stable brain metastases are eligible provided they meet the following criteria: * 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). Part 2 and part 3: Active/previous history of interstitial lung disease, pulmonary fibrosis, organizing pneumonia or non-infectious pneumonitis (any grade). Patients with a history of therapy-related pneumonitis that is considered clinically resolved are eligible. 4. Participants who experienced severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents. 5. Prior anti-cancer therapy: * 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. 8. Unresolved toxicity from prior anti-tumour therapy, defined in the inclusion criteria. Further exclusion criteria apply.

Where Is This Study? (4 UK sites)

Leicester Royal Infirmary

Leicester LE1 5WW, United Kingdom

Recruiting
Site contact (verified)

University College Hospital

London WC1E 6AG, United Kingdom

Recruiting
Site contact (verified)

The Christie Hospital

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)

Freeman Hospital

Newcastle upon Tyne NE7 7DN, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Boehringer Ingelheim

Sponsor contact

CONTACT

1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07