New drug combo takes on tough lung cancer
NCT ID NCT05990738
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 7 times
Summary
This early-stage trial tests a new antibody-like drug called BI 764532 alongside standard chemotherapy in adults with advanced small cell lung cancer that has returned after platinum-based treatment. The main goal is to find a safe dose and check for side effects. About 69 participants will receive the combination and be monitored regularly.
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) plus topotecan or other single-agent chemotherapy
- What this could lead to
- If it works, this could point toward a new combination treatment for small cell lung cancer that has stopped responding to standard chemotherapy.
- What could go wrong
- This is an early Phase 1 safety trial with only 69 participants, so it is too small to prove effectiveness. The drug may cause side effects or fail to shrink tumors.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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69 people
The number who actually took part.
- Started
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Feb 2024
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. 3. Histologically or cytologically confirmed small cell lung cancer (SCLC). Patients with tumours with mixed histology are eligible only if SCLC component is predominant and represent at least 50% of the overall tumour tissue. 4. Extensive stage - small cell lung cancer (ES-SCLC) that progressed or recurred following platinum-based treatment, and anti- programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) as applicable. 5. Patients must be eligible for single agent chemotherapy treatment (used in the trial) according to label. 6. Availability of archival tumour tissue sample. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Further inclusion criteria apply. Exclusion Criteria: 1. Previous treatment in this trial. 2. Current enrolment in another investigational device or drug trial, or \<30 days since ending another investigational device or drug trial(s). 3. Untreated or symptomatic brain metastases. Participants with treated, stable brain metastases are eligible provided they meet the following criteria: * Radiotherapy or major surgery for brain metastases was completed at least 2 weeks (for radiotherapy) or 4 weeks (for major brain metastases surgery) 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. 4. Presence of leptomeningeal carcinomatosis. 5. Prior participation in clinical trials of BI 764532, including receiving standard of care in these trials OR prior treatment with T cell engager (TcE) or cell therapies targeting delta-like ligand 3 (DLL3). 6. Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia/fatigue, CTCAE Grade 2 neuropathy, or Grade 2 endocrinopathies controlled by replacement therapy). 7. Major surgery (major according to the investigator's assessment) within 28 days prior to first administration of BI 764532 or planned during treatment period, e.g. hip replacement. 8. Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except 1. effectively treated non-melanoma skin cancers 2. effectively treated carcinoma in situ of the cervix 3. effectively treated ductal carcinoma in situ 4. other effectively treated malignancy that is considered cured by local treatment Further exclusion criteria apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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HOP Civil
Strasbourg, 67091, France
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INS Curie
Paris, 75005, France
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Institut Gustave Roussy
Villejuif, 94805, France
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Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
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Mayo Clinic - Florida
Jacksonville, Florida, 32224, United States
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MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
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Polish Mother's Memorial Hospital - Research Institute
Lodz, 93-338, Poland
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Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, 69126, Germany
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University of Miami
Miami, Florida, 33136, United States
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Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
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Universitätsklinikum Erlangen
Erlangen, 91054, Germany
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Universitätsklinikum Würzburg AÖR
Würzburg, 97078, Germany
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Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
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Virginia Commonwealth University
Richmond, Virginia, 23219, United States
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