Last reviewed · How we verify
NCT04429087
A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3
Phase 1 trial testing BI 764532 - parenteral 1 in Patients With Small Cell Lung Carcinoma and Other Neoplasms in 300 participants. Currently enrolling.
1 September 2026
Quick facts
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 29 July 2020 |
| Primary completion | 1 September 2026 |
| Estimated completion | 15 February 2027 |
| Sites | 12 locations across Japan, United States, Germany, Spain |
Drugs / interventions tested
- BI 764532 - parenteral 1 — full drug profile →
- BI 764532 - parenteral 2 — full drug profile →
Conditions studied
- Patients With Small Cell Lung Carcinoma and Other Neoplasms — all drugs for Patients With Small Cell Lung Carcinoma and Other Neoplasms →
Sponsor
Boehringer Ingelheim — full company profile →
Who can join
18 and older, any sex, with Patients With Small Cell Lung Carcinoma and Other Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is open to adults with small cell lung cancer and other neuroendocrine cancers that are positive for the tumour marker delta-like 3 (DLL3). 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 out the highest dose of BI 764532 and the best treatment schedule that people can tolerate. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. In this study, BI 764532 is given to people for the first time. That means no clinical data are available for BI 764532. Participants get BI 764532 either weekly or once every 3 weeks. If there is benefit for the participants and if they can tolerate it, the treatment is given for a maximum of 3 years. During this time, participants visit the study site about 20 times depending on the response to the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Emerging therapies targeting the delta-like ligand 3 (DLL3) in small cell lung cancer.
Rudin CM, Reck M, Johnson ML, Blackhall F, et al · · 2023 · cited 112× · PMID 37355629 · DOI 10.1186/s13045-023-01464-y -
DLL3 as an Emerging Target for the Treatment of Neuroendocrine Neoplasms.
Yao J, Bergsland E, Aggarwal R, Aparicio A, et al · · 2022 · cited 67× · PMID 35983951 · DOI 10.1093/oncolo/oyac161 -
Development of pharmacological immunoregulatory anti-cancer therapeutics: current mechanistic studies and clinical opportunities.
Yin N, Li X, Zhang X, Xue S, et al · · 2024 · cited 48× · PMID 38773064 · DOI 10.1038/s41392-024-01826-z -
Current Landscape of Cancer Immunotherapy: Harnessing the Immune Arsenal to Overcome Immune Evasion.
Mitra A, Kumar A, Amdare NP, Pathak R. · · 2024 · cited 34× · PMID 38785789 · DOI 10.3390/biology13050307 -
DLL3-guided therapies in small-cell lung cancer: from antibody-drug conjugate to precision immunotherapy and radioimmunotherapy.
Su PL, Chakravarthy K, Furuya N, Brownstein J, et al · · 2024 · cited 33× · PMID 38730427 · DOI 10.1186/s12943-024-02012-z -
Expanding Therapeutic Opportunities for Extrapulmonary Neuroendocrine Carcinoma.
Frizziero M, Kilgour E, Simpson KL, Rothwell DG, et al · · 2022 · cited 30× · PMID 35091446 · DOI 10.1158/1078-0432.ccr-21-3058 -
Current therapy and development of therapeutic agents for lung cancer.
Wang Z, Kim J, Zhang P, Galvan Achi JM, et al · · 2022 · cited 19× · PMID 37193130 · DOI 10.1016/j.cellin.2022.100015 -
Potent molecular-targeted therapies for gastro-entero-pancreatic neuroendocrine carcinoma.
Ooki A, Osumi H, Fukuda K, Yamaguchi K. · · 2023 · cited 16× · PMID 37422534 · DOI 10.1007/s10555-023-10121-2
Verify or expand the search:
- PubMed search for NCT04429087
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Boehringer Ingelheim trials
Trials by the same sponsor.
- NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
- NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
- NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
- NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
- NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04429087 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
- Last refreshed: 10 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04429087.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing