Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Small Cell Lung Carcinoma (SCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 (Prog...
Eligibility Criteria
Inclusion
- 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)
- 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
- 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 or cisplatin, 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 Further inclusion criteria apply.
Exclusion
- Previous treatment in this trial
- Treatment with a systemic anti-cancer therapy or investigational drug within 28 days or 5 half-lives (whichever is longer) of the first administration of trial medication
- Presence of leptomeningeal carcinomatosis
- Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers and cell therapies
- Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532
- 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)
- 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
- Any documented active or suspected malignancy or history of malignancy within 5 years prior to Screening (other than the target indication), except for appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix Further exclusion criteria apply.
Key Trial Info
Start Date :
February 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06077500
Start Date
February 14 2024
End Date
September 1 2026
Last Update
January 6 2026
Active Locations (21)
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1
Orlando Health Cancer Institute
Orlando, Florida, United States, 32806
2
Emory University
Atlanta, Georgia, United States, 30322
3
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
4
AZ Groeninge
Kortrijk, Belgium, 8500