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

March 25, 2024 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
  • Bulgaria
      • Panagyurishte, Bulgaria, 4500
      • Pleven, Bulgaria, 5800
  • China
      • Chengdu, China, 610041
      • Hangzhou, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
        • Contact:
      • Jinan, China, 250031
        • Recruiting
        • 960 Hospital of the Chinese People's Liberation Army
        • Contact:
      • Jinan, China, 250012
        • Recruiting
        • Qilu Hospital, Shangdong University
        • Contact:
      • Nanchang, China, 330006
        • Recruiting
        • The Second Affiliated Hospital to Nanchang University
        • Contact:
      • Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
  • Germany
      • Berlin, Germany, 13125
      • Dresden, Germany, 01307
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus Dresden
        • Contact:
      • Erlangen, Germany, 91054
      • Gauting, Germany, 82131
      • Großhansdorf, Germany, 22927
      • Mainz, Germany, 55131
        • Recruiting
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • Contact:
  • Japan
      • Aichi, Nagoya, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center Hospital
        • Contact:
      • Chiba, Kashiwa, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
        • Contact:
      • Miyagi, Sendai, Japan, 980-0873
      • Osaka, Osaka, Japan, 541-8567
        • Recruiting
        • Osaka International Cancer Institute
        • Contact:
      • Osaka, OsakaSayama, Japan, 589-8511
        • Recruiting
        • Kindai University Hospital
        • Contact:
      • Tokyo, Chuo-ku, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
        • Contact:
      • Tokyo, Koto-ku, Japan, 135-8550
        • Recruiting
        • Japanese Foundation for Cancer Research
        • Contact:
  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
      • Seoul, Korea, Republic of, 06351
      • Seoul, Korea, Republic of, 03722
  • Portugal
      • Lisboa, Portugal, 1350-352
      • Porto, Portugal, 4100-180
  • Spain
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08035
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Malaga, Spain, 29010
        • Recruiting
        • Hospital Virgen de la Victoria
        • Contact:
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico de Valencia
        • Contact:
  • Taiwan
      • Tainan, Taiwan, 704
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
      • Taoyuan County, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital(Linkou)
        • Contact:
  • United Kingdom
      • Leicester, United Kingdom, LE1 5WW
      • London, United Kingdom, WC1E 6AG
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36607
    • California
      • Los Angeles, California, United States, 90067
      • San Francisco, California, United States, 94143
    • Florida
      • Miami, Florida, United States, 33136
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Kentucky
      • Lexington, Kentucky, United States, 40536
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • New York
      • Bronx, New York, United States, 10461
      • New York, New York, United States, 10016
        • Recruiting
        • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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; in countries where standard of care in first line therapy includes PD-L1 inhibitor treatment patients should have received the combination of platinum-based regimen plus PD-L1 inhibitor unless they have been unable to receive checkpoint inhibitor treatment.
    • 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, peripheral neuropathy, fatigue and endocrinopathies controlled by replacement therapy 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose group 1
Drug: BI 764532, formulation 1
BI 764532, formulation 1
Drug: BI 764532, formulation 2
BI 764532, formulation 2
Experimental: Dose group 2
Drug: BI 764532, formulation 1
BI 764532, formulation 1
Drug: BI 764532, formulation 2
BI 764532, formulation 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 23 months
Occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment period
Time Frame: up to 23 months
up to 23 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 23 months
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.
up to 23 months
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
up to 23 months
Overall survival (OS), defined as the time from treatment start until death from any cause
Time Frame: up to 23 months
up to 23 months
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.
at baseline, at month 23
Change from baseline in EORTC QLQ-C30 role functioning domain score
Time Frame: at baseline, at month 23
at baseline, at month 23
Occurrence of treatment-emergent AEs leading to study drug discontinuation during the on-treatment period
Time Frame: up to 23 months
up to 23 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2023

Primary Completion (Estimated)

September 25, 2024

Study Completion (Estimated)

July 3, 2025

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1438-0005
  • 2023-504247-13-00 (Registry Identifier: CTIS)
  • U1111-1292-4406 (Registry Identifier: UTN, WHO registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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