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Small Cell Lung Carcinoma (SCLC)Phase 1DAREONᵀᴹ-8NCT06077500

DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer

A Phase 1 study testing BI 764532, Carboplatin and Etoposide in people with Small Cell Lung Carcinoma (SCLC), run by Boehringer Ingelheim at 21 sites in 8 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 are eligible for standard of care including chemotherapy and anti-PD-L1 (Programmed Cell Death Ligand 1) immunotherapy. 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, Carboplatin and Etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
21 sitesin 8 countries
Study dates
14 Feb 2024to 1 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 Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
  • Histologically or cytologically confirmed extensive-stage small cell lung carcinoma (ES-SCLC)
  • Availability of archival tumour tissue
  • Patients must be eligible for platinum+etoposide+anti-Programmed Cell Death Ligand 1 (PD-L1) regimen as first line standard of care (SoC) treatment:
  • In Part A, patients must be eligible to receive carboplatin + etoposide + atezolizumab
Show all 10Show fewer
  • In Part B, patients must be eligible to receive etoposide, carboplatin or cisplatin, and atezolizumab or durvalumab
  • No prior systemic treatment for ES-SCLC
  • Prior systematic anti-cancer treatment for limited-stage small cell lung cancer (SCLC) must have been complete at least 6 months prior to the diagnosis of ES-SCLC
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Further inclusion criteria apply.

Who cannot join

  • Previous treatment in this trial
  • Treatment with a systemic anti-cancer therapy or investigational drug within 28 days or 5 half-lives (whichever is longer) of the first administration of trial medication
  • Presence of leptomeningeal carcinomatosis
  • Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers and cell therapies
  • Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532
  • 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
  • Any documented active or suspected malignancy or history of malignancy within 5 years prior to Screening (other than the target indication), except for appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix Further exclusion criteria apply.

Trial locations and contacts

21 sites in 8 countries.

21 sites in 8 countries

France4 sites

  • INS Bergonie

    Bordeaux, 33000

  • Hopital Louis Pradel

    Bron, 69677

  • HOP Civil

    Strasbourg, 67091

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Japan4 sites

  • Saitama Medical University International Medical Center

    Saitama, Hidaka, 350-1298

  • Hamamatsu University Hospital

    Shizuoka, Hamamatsu, 431-3192

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045

  • Japanese Foundation for Cancer Research

    Tokyo, Koto-ku, 135-8550

Other trials in Japan

Spain4 sites

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario Virgen De La Macarena

    Seville, 41009

  • Instituto Valenciano de Oncología

    Valencia, 46009

Other trials in Spain

Poland3 sites

  • Medical University Gdansk

    Gdansk, 80-214

  • Polish Mother's Memorial Hospital - Research Institute

    Lodz, 93-338

  • Med Polonia Sp. z o.o

    Poznan, 60-693

Other trials in Poland

United States2 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

Other trials in United States

Belgium2 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • AZ Groeninge

    Kortrijk, 8500

Other trials in Belgium

Germany1 site

  • Universitätsklinikum Gießen und Marburg GmbH

    Giessen, 35392

Other trials in Germany

Switzerland1 site

  • University Hospital of Lausanne

    Lausanne, 1011

Other trials in Switzerland

About this study

Official title: DAREONᵀᴹ-8: A Phase I, Open-label, Dose Escalation and Expansion Trial of Repeated Intravenous Infusions of BI 764532 Combined With Standard of Care (Platinium, Etoposide, and Anti-PD-L1) in Patients With Extensive-stage Small Cell Lung Carcinoma

This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that are eligible for standard of care including chemotherapy and anti-PD-L1 (Programmed Cell Death Ligand 1) immunotherapy.

The purpose of this study is to find out the highest dose of BI 764532 (also called obrixtamig) that people can tolerate when taken together with standard of care. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. Participants get BI 764532 and different standard treatments as infusions into a vein.

If there is benefit for the participants and if they can tolerate it, the treatment is given for the entire duration of the study. 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, Carboplatin, Etoposide, Atezolizumab
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.

Study groups in NCT06077500
Study groupRoleWhat they receive
Part A - Dose escalation: BI 764532 very low dose + carboplatin + etoposide + atezolizumabExperimentalNot described
Receives: Drug: BI 764532; Drug: Carboplatin; Drug: Etoposide; Drug: Atezolizumab
Part A - Dose escalation: BI 764532 low dose + carboplatin + etoposide + atezolizumabExperimentalNot described
Receives: Drug: BI 764532; Drug: Carboplatin; Drug: Etoposide; Drug: Atezolizumab
Part A - Dose escalation: BI 764532 medium dose + carboplatin + etoposide + atezolizumabExperimentalNot described
Receives: Drug: BI 764532; Drug: Carboplatin; Drug: Etoposide; Drug: Atezolizumab
Part A - Dose escalation: BI 764532 high dose + carboplatin + etoposide + atezolizumabExperimentalNot described
Receives: Drug: BI 764532; Drug: Carboplatin; Drug: Etoposide; Drug: Atezolizumab
Part B - Dose expansion: BI 764532 + carboplatin + etoposide + atezolizumabExperimentalNot described
Receives: Drug: BI 764532; Drug: Carboplatin; Drug: Etoposide; Drug: Atezolizumab

What is being measured

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

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

    Measured: up to 6 weeks

  2. Part B - Dose expansion: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period

    Measured: up to 23 months

Secondary outcomes (4)

  1. Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period

    Measured: up to 23 months

  2. Part A - Dose escalation: Occurrence of adverse events (AEs) during the on-treatment period

    Measured: up to 23 months

  3. Part B - Dose expansion: Objective response (OR)

    OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 (based on investigator's assessment) from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent

    Measured: up to 23 months

  4. Part B - Dose expansion: Duration of response (DoR)

    DoR is defined as the time from first documented confirmed objective response (OR) until the earliest date of disease progression or death among patients with confirmed objective response

    Measured: up to 23 months

Timeline

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

  1. First posted11 Oct 2023
  2. Study start14 Feb 2024
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion1 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
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06077500
Sponsor's protocol ID
1438-0008
Other IDs
U1111-1291-5998, 2023-506008-20-00, 2023
Acronym
DAREONᵀᴹ-8
Status last verified
Oct 2026
First submitted
5 Oct 2023
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 764532, Carboplatin and Etoposide in people with Small Cell Lung Carcinoma (SCLC), run by Boehringer Ingelheim at 21 sites in 8 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 10 inclusion and 8 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in France, Japan, Spain, Poland, United States and 3 more countries. 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 - Dose escalation: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period (time frame: up to 6 weeks). The study lists 2 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 NCT06077500.

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 27 Oct 2026.

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