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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 Topotecan

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.
 
ClinicalTrials.gov Identifier: NCT05990738
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : May 14, 2024
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief 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 topotecan treatment.

The purpose of this study is to find out the highest dose of BI 764532 that people can tolerate when taken together with topotecan. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. Participants get BI 764532 and topotecan as infusions into a vein. As an alternative, topotecan may also be taken orally (tablets).

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.


Condition or disease Intervention/treatment Phase
Small Cell Lung Carcinoma (SCLC) Drug: BI 764532 Drug: Topotecan Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DAREON™-9: A Phase Ib Open-label Dose Escalation and Dose Confirmation Safety Study of Intravenous BI 764532 in Combination With Topotecan for the Treatment of Patients With Small Cell Lung Cancer
Actual Study Start Date : January 15, 2024
Estimated Primary Completion Date : October 27, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A: BI 764532 low dose + topotecan Drug: BI 764532
BI 764532

Drug: Topotecan
Topotecan
Experimental: Part A: BI 764532 medium dose + topotecan Drug: BI 764532
BI 764532

Drug: Topotecan
Topotecan
Experimental: Part A: BI 764532 high dose + topotecan Drug: BI 764532
BI 764532

Drug: Topotecan
Topotecan
Experimental: Part B: BI 764532 + topotecan Drug: BI 764532
BI 764532

Drug: Topotecan
Topotecan


Outcome Measures
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Primary Outcome Measures :
  1. Part A: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period [ Time Frame: up to 9 weeks ]
  2. Part B: Occurrence of DLTs during the on-treatment period [ Time Frame: up to 36 months ]
  3. Part B: Occurrence of AEs during the on-treatment period [ Time Frame: up to 36 months ]

Secondary Outcome Measures :
  1. Part A: Occurrence of DLTs during the on-treatment period [ Time Frame: up to 36 months ]
  2. Part A: Occurrence of AEs during the on-treatment period [ Time Frame: up to 36 months ]
  3. Part B: Objective response [ Time Frame: up to 36 months ]
  4. Part B: Duration of response [ Time Frame: up to 36 months ]

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

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 Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
  3. Histologically or cytologically confirmed small cell lung cancer (SCLC)
  4. 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
  5. Patients must be eligible for topotecan treatment according to label
  6. Availability of archival tumour tissue sample
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Further inclusion criteria apply

Exclusion Criteria:

  1. Previous treatment in this trial
  2. Current enrolment in another investigational device or drug trial, or <30 days since ending another investigational device or drug trial(s)

  3. 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.
  4. Presence of leptomeningeal carcinomatosis
  5. Previous treatment with T cell engager (TcE) or cell therapies targeting delta-like ligand 3 (DLL3).
  6. 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).
  7. 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.

  8. Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except

    1. effectively treated non-melanoma skin cancers
    2. effectively treated carcinoma in situ of the cervix
    3. effectively treated ductal carcinoma in situ
    4. other effectively treated malignancy that is considered cured by local treatment Further exclusion criteria apply
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT05990738


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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France
INS Curie Recruiting
Paris, France, 75005
Contact: Boehringer Ingelheim    0805102354    france@bitrialsupport.com   
Germany
Universitätsklinikum Carl Gustav Carus Dresden Recruiting
Dresden, Germany, 01307
Contact: Boehringer Ingelheim    08007234742    deutschland@bitrialsupport.com   
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Boehringer Ingelheim    08007234742    deutschland@bitrialsupport.com   
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69126
Contact: Boehringer Ingelheim    08007234742    deutschland@bitrialsupport.com   
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Recruiting
Mainz, Germany, 55131
Contact: Boehringer Ingelheim    08007234742    deutschland@bitrialsupport.com   
Universitätsklinikum Würzburg AÖR Recruiting
Würzburg, Germany, 97078
Contact: Boehringer Ingelheim    08007234742    deutschland@bitrialsupport.com   
Poland
Polish Mother's Memorial Hospital - Research Institute Recruiting
Lodz, Poland, 93-338
Contact: Boehringer Ingelheim    008001218830    polska@bitrialsupport.com   
United Kingdom
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom, LE1 5WW
Contact: Boehringer Ingelheim    08000514022    unitedkingdom@bitrialsupport.com   
Sponsors and Collaborators
Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT05990738    
Other Study ID Numbers: 1438-0009
2023-506007-26-00 ( Registry Identifier: CTIS (EU) )
U1111-1293-4098 ( Registry Identifier: WHO Registry )
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: May 14, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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.mystudywindow.com/msw/datatransparency

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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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Small Cell Lung Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents