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 now Phase 2 Last updated 6 February 2026

What this trial tests

Phase 2 trial testing BI 764532, dose 1 in Small Cell Lung Carcinoma in 174 participants. Currently enrolling.

Timeline

13 October 2023

Primary endpoint
1 September 2027

24 February 2028

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	174
Start date	13 October 2023
Primary completion	1 September 2027
Estimated completion	24 February 2028
Sites	59 locations across France, Japan, Belgium, Taiwan, United Kingdom, Germany, South Korea, Bulgaria

Drugs / interventions tested

• BI 764532, dose 1 — full drug profile →
• BI 764532, dose 2

Conditions studied

• Small Cell Lung Carcinoma — all drugs for Small Cell Lung Carcinoma →
• Neuroendocrine Neoplasms — all drugs for Neuroendocrine Neoplasms →
• Extra-pulmonary Neuroendocrine Carcinoma — all drugs for Extra-pulmonary Neuroendocrine Carcinoma →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Small Cell Lung Carcinoma or Neuroendocrine 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 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 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 2 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, all participants receive the same dose of BI 764532. Part 2 is 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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
2. Insights into next-generation immunotherapy designs and tools: molecular mechanisms and therapeutic prospects.
   Qin H, Zhou Z, Shi R, Mai Y, et al · · 2025 · cited 15× · PMID 40483473 · DOI 10.1186/s13045-025-01701-6
3. Advances in DLL3-targeted therapies for small cell lung cancer: challenges, opportunities, and future directions.
   Ding J, Yeong C. · · 2024 · cited 11× · PMID 39703856 · DOI 10.3389/fonc.2024.1504139
4. Advances in new targets for immunotherapy of small cell lung cancer.
   Zheng Z, Liu J, Ma J, Kang R, et al · · 2024 · cited 11× · PMID 38093497 · DOI 10.1111/1759-7714.15178
5. New developments in immunotherapy for SCLC.
   Dolkar T, Gates C, Hao Z, Munker R. · · 2025 · cited 9× · PMID 39762075 · DOI 10.1136/jitc-2024-009667
6. Phase I Dose-Escalation Results for the Delta-Like Ligand 3/CD3 IgG-Like T-Cell Engager Obrixtamig (BI 764532) in Patients With Delta-Like Ligand 3+ Small Cell Lung Cancer or Neuroendocrine Carcinomas.
   Wermke M, Gambardella V, Kuboki Y, Felip E, et al · · 2025 · cited 8× · PMID 40706016 · DOI 10.1200/jco-25-00363
7. Small cell lung cancer: emerging subtypes, signaling pathways, and therapeutic vulnerabilities.
   Zhang J, Zeng X, Guo Q, Sheng Z, et al · · 2024 · cited 8× · PMID 39103941 · DOI 10.1186/s40164-024-00548-w
8. Lineage plasticity and histological transformation: tumor histology as a spectrum.
   Li X, Gardner EE, Molina-Pinelo S, Wilhelm C, et al · · 2025 · cited 6× · PMID 41023204 · DOI 10.1038/s41422-025-01180-x