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New drug aims to shrink Hard-to-Treat lung cancers

NCT ID NCT05882058

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 4 times

Summary

This phase 2 trial tests BI 764532 (obrixtamig), an antibody-like drug designed to help the immune system attack cancer cells. It is for adults with advanced small cell lung cancer or other neuroendocrine cancers that have not responded to prior treatments. The study compares two doses to find one that is tolerable and effective, with the goal of shrinking tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BI 764532 (obrixtamig), an antibody-like molecule that helps the immune system fight cancer
What this could lead to
If it works, this could point toward a new treatment option for people with advanced small cell lung cancer or other neuroendocrine cancers that have stopped responding to standard therapy.
What could go wrong
This is a mid-stage trial with only 204 participants, so results may not apply to everyone. The drug may cause side effects or fail to shrink tumors in many patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 204 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF). 2. 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. 3. Part 1: 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. Patients must have progressed or recurred after standard of care therapy * SCLC: after at least two prior lines of therapy, including at least one platinum-based regimen; in countries where standard of care in first line therapy includes PD-L1 inhibitor treatment patients should have received the combination of platinum-based regimen plus PD-L1 inhibitor unless they have been unable to receive checkpoint inhibitor treatment. * Therapy includes PD-L1 inhibitor treatment; patients should have received the combination of platinum-based regimen plus PD-L1 inhibitor unless they have been unable to receive checkpoint inhibitor treatment. * epNEC/LCNEC: after at least one platinum-based regimen. Part 2 and part 3: Histologically or cytologically confirmed epNEC (except MCC, MTC and NEPC) with centrally assessed DLL3 high expression status. Patients must have progressed or recurred after at least one platinum-based regimen. 4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1., 5. Measurable lesions as defined per Response Evaluation Criteria In Solid Tumours (RECIST) v 1.1 within 21 days prior to the first dose of BI 764532. 6. Part 1: Availability of archival tumour tissue sample Part 2 and part 3: Availability of archival formalin-fixed paraffin-embedded (FFPE) tumour tissue sample. Following specimens are not allowed: Fine Needle Aspiration (FNA), Cytology samples, decalcified bone samples. 7. Adequate organ function as defined in the protocol. 8. All toxicities related to previous anti-cancer therapies have resolved = Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to trial treatment administration (except for alopecia, peripheral neuropathy, fatigue and endocrinopathies controlled by replacement therapy which must be = CTCAE Grade 2 and amenorrhea/menstrual disorders which can be any grade). 9. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information 10. Only for Part 3, at the timepoint of Screening 02: * For Cycle 1, patients should be willing to stay within 1 hour driving distance for 48 hours after IMP administration and confirm availability of a caregiver for the same timeframe. * Patients should be considered suitable by the investigator to follow instructions applicable to the reduced monitoring cohort, such as taking their temperature and administration of oral medication at home if needed. Exclusion criteria: 1. Untreated or symptomatic brain metastases. (Part 2 and part 3: identified during the mandatory assessment by brain MRI within 21 days before first trial drug administration.) Participants with treated, stable brain metastases are eligible provided they meet the following criteria: * Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 764532. * Patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant central nervous system (CNS) disease. 2. Presence of leptomeningeal disease or, part 2 and part 3: epidural disease including spinal cord compression. 3. Part 1: Active/previous history of interstitial lung disease or non-infectious pneumonitis (any grade). Part 2 and part 3: Active/previous history of interstitial lung disease, pulmonary fibrosis, organizing pneumonia or non-infectious pneumonitis (any grade). Patients with a history of therapy-related pneumonitis that is considered clinically resolved are eligible. 4. Participants who experienced severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents. 5. Prior anti-cancer therapy: * Patients who have been treated with any other anti-cancer drug within 4 weeks or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532. * Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532. 6. Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers or cell therapies. 7. Diagnosis of immunodeficiency or systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of BI 764532. Physiological replacement of steroids is allowed. 8. Unresolved toxicity from prior anti-tumour therapy, defined in the inclusion criteria. Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

neuroendocrine carcinoma neuroendocrine neoplasm pulmonary large cell neuroendocrine carcinoma small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Extra-pulmonary neuroendocrine carcinoma Neuroendocrine neoplasms Small cell lung carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    37 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 960 Hospital of the Chinese People's Liberation Army

    RECRUITING

    Jinan, 250031, China

  • Aichi Cancer Center Hospital

    RECRUITING

    Aichi, Nagoya, 464-8681, Japan

  • Asan Medical Center

    COMPLETED

    Seoul, 05505, South Korea

  • Asklepios Fachkliniken München-Gauting

    COMPLETED

    Gauting, 82131, Germany

  • Chang Gung Memorial Hospital, Linkou

    COMPLETED

    Taoyuan County, 333, Taiwan

  • Dana-Farber Cancer Institute

    COMPLETED

    Boston, Massachusetts, 02215, United States

  • Evangelische Lungenklinik Berlin

    COMPLETED

    Berlin, 13125, Germany

  • Freeman Hospital

    RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • H. Lee Moffitt Cancer Center and Research Institute

    RECRUITING

    Tampa, Florida, 33612, United States

  • HOP Civil

    COMPLETED

    Strasbourg, 67091, France

  • HOP Intercommunal

    COMPLETED

    Créteil, 94000, France

  • Hospital CUF Descobertas-Lisboa-69316

    COMPLETED

    Lisbon, 1350-352, Portugal

  • Hospital CUF Porto

    COMPLETED

    Porto, 4100-180, Portugal

  • Hospital Clinico Universitario de Valencia

    COMPLETED

    Valencia, 46010, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, 29010, Spain

  • Hospital del Mar

    COMPLETED

    Barcelona, 08003, Spain

  • Hôpital Cochin

    COMPLETED

    Paris, 75014, France

  • Indiana University

    COMPLETED

    Indianapolis, Indiana, 46202, United States

  • Infirmary Cancer Care

    RECRUITING

    Mobile, Alabama, 36607, United States

  • Japanese Foundation for Cancer Research

    RECRUITING

    Tokyo, Koto-ku, 135-8550, Japan

  • Kindai University Hospital

    RECRUITING

    Osaka, Sakai, 590-0197, Japan

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    COMPLETED

    New York, New York, 10016, United States

  • Leicester Royal Infirmary

    RECRUITING

    Leicester, LE1 5WW, United Kingdom

  • LungenClinic Grosshansdorf GmbH

    ACTIVE_NOT_RECRUITING

    Großhansdorf, 22927, Germany

  • MHAT Heart and brain

    COMPLETED

    Pleven, 5804, Bulgaria

  • Mayo Clinic Cancer Center

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic, Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic-Arizona

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.

    COMPLETED

    Panagyurishte, 4500, Bulgaria

  • NCKUH

    COMPLETED

    Tainan, 704, Taiwan

  • National Cancer Center Hospital

    RECRUITING

    Tokyo, Chuo-ku, 104-0045, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Chiba, Kashiwa, 277-8577, Japan

  • Osaka International Cancer Institute

    RECRUITING

    Osaka, Osaka, 541-8567, Japan

  • Qilu Hospital, Shangdong University

    RECRUITING

    Jinan, 250012, China

  • Samsung Medical Center

    ACTIVE_NOT_RECRUITING

    Seoul, 06351, South Korea

  • Sendai Kousei Hospital

    COMPLETED

    Miyagi, Sendai, 981-0914, Japan

  • Severance Hospital

    RECRUITING

    Seoul, 03722, South Korea

  • Shanghai Chest Hospital

    RECRUITING

    Shanghai, 200030, China

  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

    RECRUITING

    Hangzhou, 310016, China

  • Taipei Veterans General Hospital

    COMPLETED

    Taipei, 11217, Taiwan

  • The Christie Hospital

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Second Affiliated Hospital to Nanchang University

    RECRUITING

    Nanchang, 330006, China

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, 9000, Belgium

  • University College Hospital

    RECRUITING

    London, WC1E 6AG, United Kingdom

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Kansas Cancer Center

    COMPLETED

    Westwood, Kansas, 66205, United States

  • University of Kentucky Medical Center

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Maryland School of Medicine

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • Universitätsklinikum Carl Gustav Carus Dresden

    RECRUITING

    Dresden, 01307, Germany

  • Universitätsklinikum Erlangen

    RECRUITING

    Erlangen, 91054, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    RECRUITING

    Mainz, 55131, Germany

  • Valkyrie Clinical Trials

    RECRUITING

    Los Angeles, California, 90067, United States

  • Virginia Commonwealth University Health- Adult Outpatient Pavilion

    RECRUITING

    Richmond, Virginia, 23219, United States

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, 610041, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.