← Back to Search

Monoclonal Antibodies

BI 764532 for Small Cell Lung Cancer

Phase 2
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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
Must not have
Presence of leptomeningeal disease
Active/previous history of interstitial lung disease or non-infectious pneumonitis (any grade)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 23 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is for adults with advanced small-cell lung cancer & neuroendocrine tumours. It tests 2 doses of BI 764532, an antibody-like molecule, to see if it shrinks tumours & is safe & tolerable. Participants visit the study site regularly to monitor safety & record effects.

Who is the study for?
Adults with advanced small cell lung cancer or neuroendocrine tumors, who have had unsuccessful prior treatments or no standard treatment options. Participants must be over 18, have measurable lesions, provide consent, and agree to use effective birth control. They should not have severe allergies to immuno-oncology agents or certain lung conditions.
What is being tested?
The trial is testing two different doses of BI 764532, an experimental antibody-like molecule designed to help the immune system fight cancer. Patients are randomly assigned to receive one of the two doses via vein infusion and monitored for tumor response and tolerability.
What are the potential side effects?
While specific side effects are not listed here, participants will be closely monitored for any unwanted effects during their regular visits which include an initial overnight stay. Side effects could range from mild reactions at the infusion site to more serious immune-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have signed and understand the consent form for this trial.
Select...
My cancer is primarily neuroendocrine or small cell lung cancer.
Select...
My small cell lung cancer has worsened after two treatments, including a platinum-based one.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have a stored sample of my tumor tissue.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer has spread to the lining of my brain and spinal cord.
Select...
I have or had lung inflammation not caused by an infection.
Select...
I had a severe reaction to immune therapy that stopped my treatment.
Select...
I haven't taken any cancer drugs in the last 4 weeks or 5 half-lives, whichever is shorter.
Select...
I haven't had extensive radiotherapy, including to the brain, in the last 2 weeks.
Select...
I have not had treatments targeting DLL3 with T cell engagers or cell therapies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 23 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 23 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR)
Occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment period
Secondary study objectives
Change from baseline in EORTC QLQ-C30 physical functioning domain score
Change from baseline in EORTC QLQ-C30 role functioning domain score
Disease control (DC), defined as best overall response of CR or PR or stable disease (SD) based on investigator assessment
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose group 2Experimental Treatment1 Intervention
Group II: Dose group 1Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,550 Previous Clinical Trials
15,769,173 Total Patients Enrolled
~58 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top