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DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05882058
Recruitment Status : Not yet recruiting
First Posted : May 31, 2023
Last Update Posted : September 25, 2023
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

This study is open to adults with small cell lung cancer and other neuroendocrine tumours. The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists.

The purpose of this study is to find a suitable dose of BI 764532 that people with advanced cancer can tolerate when taken alone. 2 different doses of BI 764532 are tested in this study. Another purpose is to check whether BI 764532 can make tumours shrink. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer.

Participants are put into 2 groups randomly, which means by chance. One group gets dose 1 of BI 764532 and the other group gets dose 2 of BI 764532. Participants get BI 764532 infusions into a vein when starting treatment. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. The first study visits include an over-night stay to monitor participants' safety. Doctors record any unwanted effects and regularly check the general health of the participants.

Condition or disease Intervention/treatment Phase
Small Cell Lung Carcinoma Neuroendocrine Neoplasms Drug: BI 764532 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DAREON™-5: An Open-label, Multi-center Phase II Dose Selection Trial of Intravenous BI 764532, a DLL3-targeting T Cell Engager, in Patients With Relapsed/Refractory Extensive-stage Small Cell Lung Cancer and in Patients With Other Relapsed/Refractory Neuroendocrine Carcinomas
Estimated Study Start Date : September 27, 2023
Estimated Primary Completion Date : September 25, 2024
Estimated Study Completion Date : July 3, 2025

Arm Intervention/treatment
Experimental: Dose group 1 Drug: BI 764532
BI 764532

Experimental: Dose group 2 Drug: BI 764532
BI 764532

Primary Outcome Measures :
  1. Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) [ Time Frame: up to 23 months ]
    according to RECIST v 1.1 by investigator 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.

  2. Occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment period [ Time Frame: up to 23 months ]

Secondary Outcome Measures :
  1. Duration of objective response (DOR) based on investigator assessment [ Time Frame: up to 23 months ]
    DOR is defined as the time from first documented confirmed OR until the earliest date of disease progression or death among patients with confirmed OR.

  2. Progression-free survival (PFS) based on investigator assessment [ Time Frame: up to 23 months ]
    PFS is defined as the time from treatment start until the earliest date of tumour progression according RECIST v 1.1 or death from any cause, whichever occurs first.

  3. Disease control (DC), defined as best overall response of CR or PR or stable disease (SD) based on investigator assessment [ Time Frame: up to 23 months ]
    where best overall response is defined according to RECIST v 1.1, from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent

  4. Overall survival (OS), defined as the time from treatment start until death from any cause [ Time Frame: up to 23 months ]
  5. Change from baseline in EORTC QLQ-C30 physical functioning domain score [ Time Frame: at baseline, at month 23 ]

    European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) The QLQ-C30 is comprised of 30 questions. It incorporates both multi-item scales and single-item measures. These include one global health status/Quality of Life (QoL) scale, five functional scales, three symptom scales and six single items to assess dyspnea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties.

    All scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems.

  6. Change from baseline in EORTC QLQ-C30 role functioning domain score [ Time Frame: at baseline, at month 23 ]
  7. Occurrence of treatment-emergent AEs leading to study drug discontinuation during the on-treatment period [ Time Frame: up to 23 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. 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
    • epNEC/LCNEC: 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. Availability of archival tumour tissue sample.
  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 and peripheral neuropathy 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 highly effective 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

Exclusion criteria:

  1. Untreated or symptomatic brain metastases. 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.
  3. Active/previous history of interstitial lung disease or non-infectious pneumonitis (any grade).
  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 as per protocol. Further exclusion criteria apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05882058

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Contact: Boehringer Ingelheim 1-800-243-0127

Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT05882058    
Other Study ID Numbers: 1438-0005
2023-504247-13-00 ( Registry Identifier: CTIS )
First Posted: May 31, 2023    Key Record Dates
Last Update Posted: September 25, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link 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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue