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Small Cell Lung Carcinoma (SCLC)Phase 1NCT05990738

DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With a Single Agent Chemotherapy

A Phase 1 study testing BI 764532, Topotecan and Single agent chemotherapy in people with Small Cell Lung Carcinoma (SCLC), run by Boehringer Ingelheim at 14 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that had previously received platinum-based chemotherapy and are eligible to receive a single agent chemotherapy treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Carcinoma (SCLC)
What is being tested?
BI 764532, Topotecan and Single agent chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
14 sitesin 5 countries
Study dates
14 Feb 2024to 30 Apr 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • 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.
  • 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.
  • 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.
  • Patients must be eligible for single agent chemotherapy treatment (used in the trial) according to label.
  • Availability of archival tumour tissue sample.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Further inclusion criteria apply.

Who cannot join

  • Previous treatment in this trial.
  • Current enrolment in another investigational device or drug trial, or <30 days since ending another investigational device or drug trial(s).
  • 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.
  • Presence of leptomeningeal carcinomatosis.
Show all 14Show fewer
  • 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).
  • 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).
  • 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.
  • Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except
  • effectively treated non-melanoma skin cancers
  • effectively treated carcinoma in situ of the cervix
  • effectively treated ductal carcinoma in situ
  • other effectively treated malignancy that is considered cured by local treatment Further exclusion criteria apply.

Trial locations and contacts

14 sites in 5 countries.

14 sites in 5 countries

Germany5 sites

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

    Heidelberg, 69126

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Universitätsklinikum Würzburg AÖR

    Würzburg, 97078

Other trials in Germany

United States4 sites

  • Mayo Clinic - Florida

    Jacksonville, Florida, 32224

  • University of Miami

    Miami, Florida, 33136

  • Virginia Commonwealth University

    Richmond, Virginia, 23219

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

France3 sites

  • INS Curie

    Paris, 75005

  • HOP Civil

    Strasbourg, 67091

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Poland1 site

  • Polish Mother's Memorial Hospital - Research Institute

    Lodz, 93-338

Other trials in Poland

United Kingdom1 site

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

Other trials in United Kingdom

About this study

Official title: DAREON™-9: A Phase Ib Open-label Dose Escalation and Dose Confirmation Safety Study of Intravenous BI 764532 in Combination With a Single Agent Chemotherapy for the Treatment of Patients With Relapsed/Refractory Small Cell Lung Cancer After Platinum-based Chemotherapy

This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that had previously received platinum-based chemotherapy and are eligible to receive a single agent chemotherapy treatment.

The purpose of this study is to find the highest dose of BI 764532 that people can tolerate when taken together with a single agent chemotherapy. BI 764532 is an antibody-like molecule that may help the immune system fight cancer.

Participants may continue to take BI 764532 as long as they benefit from treatment and can tolerate it. During this time, participants visit the study site regularly. 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.

Being tested
BI 764532, Topotecan, Single agent chemotherapy
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 764532Drug

    Also called Obrixtamig

    BI 764532

  • TopotecanDrug

    Topotecan

  • Single agent chemotherapyDrug

    single agent chemotherapy

Study groups in NCT05990738
Study groupRoleWhat they receive
Part A: BI 764532 low dose + topotecan/single agent chemotherapyExperimentalNot described
Receives: Drug: BI 764532; Drug: Topotecan; Drug: Single agent chemotherapy
Part A: BI 764532 medium dose + topotecan/single agent chemotherapyExperimentalNot described
Receives: Drug: BI 764532; Drug: Topotecan; Drug: Single agent chemotherapy
Part A: BI 764532 high dose + topotecan/single agent chemotherapyExperimentalNot described
Receives: Drug: BI 764532; Drug: Topotecan; Drug: Single agent chemotherapy
Part B: BI 764532 + topotecanExperimentalNot described
Receives: Drug: BI 764532; Drug: Topotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period

    Measured: up to 9 weeks

  2. Part B: Occurrence of DLTs during the on-treatment period

    Measured: up to 36 months

  3. Part B: Occurrence of AEs during the on-treatment period

    Measured: up to 36 months

Secondary outcomes (4)

  1. Part A: Occurrence of DLTs during the on-treatment period

    Measured: up to 36 months

  2. Part A: Occurrence of AEs during the on-treatment period

    Measured: up to 36 months

  3. Part B: Objective response

    Measured: up to 36 months

  4. Part B: Duration of response

    Measured: up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start14 Feb 2024
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05990738
Sponsor's protocol ID
1438-0009
Other IDs
2023-506007-26-00, U1111-1293-4098, 2023
Status last verified
Sep 2026
First submitted
7 Aug 2023
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 764532, Topotecan and Single agent chemotherapy in people with Small Cell Lung Carcinoma (SCLC), run by Boehringer Ingelheim at 14 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany, United States, France, Poland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period (time frame: up to 9 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05990738.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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