RECRUITING

DAREONTM-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 a Single Agent Chemotherapy

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Conditions

Small Cell Lung Carcinoma (SCLC)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 a single agent chemotherapy treatment. The purpose of this study is to find the highest dose of BI 764532 that people can tolerate when taken together with a single agent chemotherapy. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. 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.

Official Title

DAREON™-9: A Phase Ib Open-label Dose Escalation and Dose Confirmation Safety Study of Intravenous BI 764532 in Combination With a Single Agent Chemotherapy for the Treatment of Patients With Relapsed/Refractory Small Cell Lung Cancer After Platinum-based Chemotherapy

Quick Facts

Study Start:2024-02-14
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05990738

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 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. 3. Histologically or cytologically confirmed small cell lung cancer (SCLC). Patients with tumours with mixed histology are eligible only if SCLC component is predominant and represent at least 50% of the overall tumour tissue.
  4. 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. 5. Patients must be eligible for single agent chemotherapy treatment (used in the trial) according to label.
  6. 6. Availability of archival tumour tissue sample.
  7. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Further inclusion criteria apply.
  1. 1. Previous treatment in this trial.
  2. 2. Current enrolment in another investigational device or drug trial, or \<30 days since ending another investigational device or drug trial(s).
  3. 3. Untreated or symptomatic brain metastases. Participants with treated, stable brain metastases are eligible provided they meet the following criteria:
  4. * 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.
  5. * 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.
  6. 4. Presence of leptomeningeal carcinomatosis.
  7. 5. Previous treatment with T cell engager (TcE) or cell therapies targeting delta-like ligand 3 (DLL3).
  8. 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).
  9. 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.
  10. 8. Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except
  11. 1. effectively treated non-melanoma skin cancers
  12. 2. effectively treated carcinoma in situ of the cervix
  13. 3. effectively treated ductal carcinoma in situ
  14. 4. other effectively treated malignancy that is considered cured by local treatment Further exclusion criteria apply.

Contacts and Locations

Study Contact

Boehringer Ingelheim
CONTACT
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com

Study Locations (Sites)

Mayo Clinic Cancer Center
Jacksonville, Florida, 32224
United States
University of Miami
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: Boehringer Ingelheim

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 Registration Dates

Study Start Date2024-02-14
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2024-02-14
Study Completion Date2026-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Small Cell Lung Carcinoma (SCLC)