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

Last updated: April 13, 2026
Sponsor: Boehringer Ingelheim
Overall Status: Active - Not Recruiting

Phase

1

Condition

Small Cell Lung Cancer

Carcinoma

Treatment

Atezolizumab

Carboplatin

Durvalumab

Clinical Study ID

NCT06077500
1438-0008
  • Ages > 18
  • All Genders

Study 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.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female participants ≥18 years old and at least at the legal age of consentin countries where it is greater than 18 years at the time of signature of theinformed consent form (ICF)

  • Signed and dated written informed consent in accordance with International Councilfor Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior toadmission 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

  • In Part B, patients must be eligible to receive etoposide, carboplatin orcisplatin, 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 Furtherinclusion criteria apply.

Exclusion

Exclusion Criteria:

  • Previous treatment in this trial

  • Treatment with a systemic anti-cancer therapy or investigational drug within 28 daysor 5 half-lives (whichever is longer) of the first administration of trialmedication

  • Presence of leptomeningeal carcinomatosis

  • Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers andcell therapies

  • Patients who have been treated with extensive field radiotherapy including wholebrain irradiation within 2 weeks prior to first administration of BI 764532

  • Persistent toxicity from previous treatments that has not resolved to ≤ CommonTerminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia,asthenia/fatigue, CTCAE Grade 2 neuropathy, or Grade 2 endocrinopathies controlledby replacement therapy)

  • Major surgery (major according to the investigator's assessment) within 28 daysprior 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 5years prior to Screening (other than the target indication), except forappropriately treated basal cell carcinoma of the skin or in situ carcinoma ofuterine cervix Further exclusion criteria apply.

Study Design

Total Participants: 46
Treatment Group(s): 6
Primary Treatment: Atezolizumab
Phase: 1
Study Start date:
February 14, 2024
Estimated Completion Date:
April 01, 2027

Connect with a study center

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Brussels 2800866, 1200
    Belgium

    Site Not Available

  • Brussels - UNIV Saint-Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • AZ Groeninge

    Kortrijk, 8500
    Belgium

    Site Not Available

  • Kortrijk - HOSP AZ Groeninge Kennedylaan

    Kortrijk, 8500
    Belgium

    Site Not Available

  • AZ Groeninge

    Kortrijk 2794055, 8500
    Belgium

    Site Not Available

  • Kortrijk - HOSP AZ Groeninge Kennedylaan

    Kortrijk 2794055, 8500
    Belgium

    Site Not Available

  • INS Bergonie

    Bordeaux, 33000
    France

    Site Not Available

  • INS Bergonie

    Bordeaux 3031582, 33000
    France

    Site Not Available

  • HOP Louis Pradel

    Bron, 69677
    France

    Site Not Available

  • Hôpital Louis Pradel

    Bron, 69677
    France

    Site Not Available

  • HOP Louis Pradel

    Bron 3029931, 69677
    France

    Site Not Available

  • HOP Civil

    Strasbourg, 67091
    France

    Site Not Available

  • HOP Civil

    Strasbourg 2973783, 67091
    France

    Site Not Available

  • INS Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • INS Gustave Roussy

    Villejuif 2968705, 94805
    France

    Site Not Available

  • Universitätsklinikum Gießen und Marburg GmbH

    Giessen, 35392
    Germany

    Site Not Available

  • Universitätsklinikum Gießen und Marburg GmbH

    Giessen 2920512, 35392
    Germany

    Site Not Available

  • Universitätsklinikum Gießen und Marburg GmbH

    Gießen, 35392
    Germany

    Site Not Available

  • Saitama Medical University International Medical Center

    Saitama, Hidaka, 350-1298
    Japan

    Site Not Available

  • Hamamatsu University Hospital

    Shizuoka, Hamamatsu, 431-3192
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045
    Japan

    Site Not Available

  • Japanese Foundation for Cancer Research

    Tokyo, Koto-ku, 135-8550
    Japan

    Site Not Available

  • Medical University Gdansk

    Gdansk, 80-214
    Poland

    Site Not Available

  • Medical University Gdansk

    Gdansk 3099434, 80-214
    Poland

    Site Not Available

  • Polish Mother's Memorial Hospital - Research Institute

    Lodz, 93-338
    Poland

    Site Not Available

  • Polish Mother's Memorial Hospital - Research Institute

    Lodz 3093133, 93-338
    Poland

    Site Not Available

  • MED POLONIA SP Z O O, Clinical Trials Department,Poznan

    Poznan, 60-693
    Poland

    Site Not Available

  • MED POLONIA SP Z O O, Clinical Trials Department,Poznan

    Poznan 3088171, 60-693
    Poland

    Site Not Available

  • Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Ramón y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Fundación Jiménez Díaz

    Madrid 3117735, 28040
    Spain

    Site Not Available

  • Hospital Ramón y Cajal

    Madrid 3117735, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon Y Cajal

    Madrid 3117735, 28034
    Spain

    Site Not Available

  • Hospital Virgen Macarena

    Sevilla, 41009
    Spain

    Site Not Available

  • Hospital Universitario Virgen De La Macarena

    Seville, 41009
    Spain

    Site Not Available

  • Hospital Universitario Virgen De La Macarena

    Seville 2510911, 41009
    Spain

    Site Not Available

  • Hospital Virgen Macarena

    Seville 2510911, 41009
    Spain

    Site Not Available

  • Hospital Clínico de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Instituto Valenciano de Oncología

    Valencia, 46009
    Spain

    Site Not Available

  • Hospital Clínico de Valencia

    Valencia 2509954, 46010
    Spain

    Site Not Available

  • Instituto Valenciano de Oncología

    Valencia 2509954, 46009
    Spain

    Site Not Available

  • University Hospital of Lausanne

    Lausanne, 1011
    Switzerland

    Site Not Available

  • University Hospital of Lausanne

    Lausanne 2659994, 1011
    Switzerland

    Site Not Available

  • Orlando Health Cancer Institute

    Orlando, Florida 32806
    United States

    Site Not Available

  • Orlando Health Cancer Institute

    Orlando 4167147, Florida 4155751 32806
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Emory University

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

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