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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (4 UK sites)
Leicester Royal Infirmary
Leicester LE1 5WW, United Kingdom
University College Hospital
London WC1E 6AG, United Kingdom
The Christie Hospital
Manchester M20 4BX, United Kingdom
Freeman Hospital
Newcastle upon Tyne NE7 7DN, United Kingdom
How to Get in Touch
Boehringer Ingelheim
Sponsor contactCONTACT
