Testing different doses of BI 764532 for advanced small cell lung cancer
DAREONᵀᴹ-8: A Phase I, Open-label, Dose Escalation and Expansion Trial of Repeated Intravenous Infusions of BI 764532 Combined With Standard of Care (Platinium, Etoposide, and Anti-PD-L1) in Patients With Extensive-stage Small Cell Lung Carcinoma
This study is testing different doses of a new drug called BI 764532 to see if it can help adults with advanced small cell lung cancer when used with standard treatments like chemotherapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boehringer Ingelheim Industry-sponsored |
| Drugs / interventions | atezolizumab, durvalumab, chemotherapy, immunotherapy |
| Locations | 22 sites (Orlando, Florida and 21 other locations) |
| Trial ID | NCT06077500 on ClinicalTrials.gov |
What this trial studies
This study is designed for adults with extensive stage small cell lung cancer who are eligible for standard treatments like chemotherapy and anti-PD-L1 immunotherapy. The main goal is to determine the highest tolerable dose of BI 764532 when combined with standard care. Participants will receive infusions of BI 764532 along with other treatments, and their health will be monitored through regular visits to the study site. The study aims to assess both the safety and efficacy of the treatment regimen over the duration of the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed extensive-stage small cell lung carcinoma who have not received prior systemic treatment.
Not a fit: Patients with limited-stage small cell lung cancer or those who have previously undergone systemic treatment for extensive-stage disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with advanced small cell lung cancer.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, but this specific combination is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Orlando, Florida and 21 other locations
- Orlando Health Cancer Institute — Orlando, Florida, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Brussels - UNIV Saint-Luc — Bruxelles, Belgium (Not_yet_recruiting)
- Kortrijk - HOSP AZ Groeninge Kennedylaan — Kortrijk, Belgium (Recruiting)
- INS Bergonie — Bordeaux, France (Recruiting)
- HOP Louis Pradel — Bron, France (Not_yet_recruiting)
- HOP Civil — Strasbourg, France (Recruiting)
- INS Gustave Roussy — Villejuif, France (Recruiting)
- Universitätsklinikum Gießen und Marburg GmbH — Gießen, Germany (Not_yet_recruiting)
- Saitama Medical University International Medical Center — Saitama, Hidaka, Japan (Recruiting)
- Hamamatsu University Hospital — Shizuoka, Hamamatsu, Japan (Recruiting)
- National Cancer Center Hospital — Tokyo, Chuo-ku, Japan (Recruiting)
- Japanese Foundation for Cancer Research — Tokyo, Koto-ku, Japan (Recruiting)
- Medical University Gdansk — Gdansk, Poland (Recruiting)
- Polish Mother's Memorial Hospital - Research Institute — Lodz, Poland (Recruiting)
- MED POLONIA SP Z O O, Clinical Trials Department,Poznan — Poznan, Poland (Recruiting)
- Hospital Ramón y Cajal — Madrid, Spain (Recruiting)
- Fundación Jiménez Díaz — Madrid, Spain (Recruiting)
- Hospital Virgen Macarena — Sevilla, Spain (Recruiting)
- Instituto Valenciano de Oncología — Valencia, Spain (Recruiting)
- Hospital Clínico de Valencia — Valencia, Spain (Not_yet_recruiting)
- University Hospital of Lausanne — Lausanne, Switzerland (Recruiting)
Study contacts
- Study coordinator: Boehringer Ingelheim
- Email: clintriage.rdg@boehringer-ingelheim.com
- Phone: 1-800-243-0127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.