NCT05879978 is a Phase 1 clinical trial of Obrixtamig in Small Cell Lung Carcinoma (SCLC), sponsored by Boehringer Ingelheim.

Who is sponsoring NCT05879978?

NCT05879978 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT05879978?

Interventions in NCT05879978: Obrixtamig, Ezabenlimab.

What condition does NCT05879978 study?

NCT05879978 studies Small Cell Lung Carcinoma (SCLC), Neuroendocrine Neoplasms.

Is NCT05879978 still recruiting?

NCT05879978 is currently active, enrolled. Last updated 2 April 2026.

Last reviewed 2026-04-02 · How we verify

NCT05879978

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Test How Well Different Doses of Obrixtamig (BI 764532) in Combination With Ezabenlimab Are Tolerated by People With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3

Active, enrolled Phase 1 Last updated 2 April 2026

What this trial tests

Phase 1 trial testing Obrixtamig in Small Cell Lung Carcinoma (SCLC) in 45 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

27 June 2023

Primary endpoint
11 June 2025

30 June 2026

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	27 June 2023
Primary completion	11 June 2025
Estimated completion	30 June 2026
Sites	8 locations across Belgium, France, Japan, Germany

Drugs / interventions tested

Obrixtamig — full drug profile →
Ezabenlimab — full drug profile →

Conditions studied

Small Cell Lung Carcinoma (SCLC) — all drugs for Small Cell Lung Carcinoma (SCLC) →
Neuroendocrine Neoplasms — all drugs for Neuroendocrine Neoplasms →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Small Cell Lung Carcinoma (SCLC) 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 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 obrixtamig that people can tolerate when taken together with another medicine called ezabenlimab. Obrixtamig and ezabenlimab may help the immune system fight cancer. Participants get obrixtamig and ezabenlimab as infusions into a vein. 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 every week. The visits also depend on the response to the treatment. At the study visits, the doctors check the health of the participants, take necessary laboratory tests, and note any health problems that could have been caused by the study treatment.

Publications & conference data

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

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
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
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
New tricks for an old pathway: emerging Notch-based biotechnologies and therapeutics.
Medina E, Perez DH, Antfolk D, Luca VC. · · 2023 · cited 11× · PMID 37891017 · DOI 10.1016/j.tips.2023.09.011
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
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
Advancement Opportunities and Endeavor of Innovative Targeted Therapies for Small Cell Lung Cancer.
Ouyang W, Xu Z, Guan S, Hu Y, et al · · 2025 · cited 6× · PMID 39897044 · DOI 10.7150/ijbs.105973
Adopting tomorrow's therapies today: a perspective review of adoptive cell therapy in lung cancer.
Abodunrin F, Olson DJ, Emehinola O, Bestvina CM. · · 2025 · cited 5× · PMID 40012708 · DOI 10.1177/17588359251320280

Verify or expand the search:

Other recruiting trials for Small Cell Lung Carcinoma (SCLC)

Currently open trials in the same condition.

NCT05963867 — A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer · Phase 1 · recruiting
NCT06077500 — DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by Peopl · Phase 1 · active not recruiting
NCT05990738 — DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer Whe · Phase 1 · active not recruiting

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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05879978 (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: 2 April 2026

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/NCT05879978.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing