Clinical trial NCT06077500: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Small Cell Lung Carcinoma (SCLC)
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-10-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 (Programmed Cell Death Ligand 1) immunotherapy.

The purpose of this study is to find out the highest dose of BI 764532 that people can tolerate when taken together with standard of care. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. Participants get BI 764532 and different standard treatments as infusions into a vein.

If there is benefit for the participants and if they can tolerate it, the treatment is given for the entire duration of the study. 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.


Eligibility 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.

Primary outcomes:
measure: Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
timeFrame: up to 6 weeks
measure: Part B - Dose expansion: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period
timeFrame: up to 23 months
Secondary outcomes:
measure: Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period
timeFrame: up to 23 months
measure: Part A - Dose escalation: Occurrence of adverse events (AEs) during the on-treatment period
timeFrame: up to 23 months
measure: Part B - Dose expansion: Objective response (OR)
timeFrame: up to 23 months
measure: Part B - Dose expansion: Duration of response (DoR)
timeFrame: up to 23 months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health Cancer Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Bruxelles
country: Belgium
facility: Brussels - UNIV Saint-Luc
city: Kortrijk
country: Belgium
facility: Kortrijk - HOSP AZ Groeninge Kennedylaan
city: Bordeaux
country: France
facility: INS Bergonie
city: Bron
country: France
facility: HOP Louis Pradel
city: Strasbourg
country: France
facility: HOP Civil
city: Villejuif
country: France
facility: INS Gustave Roussy
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH
city: Saitama, Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
city: Shizuoka, Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
city: Tokyo, Chuo-ku
country: Japan
facility: National Cancer Center Hospital
city: Tokyo, Koto-ku
country: Japan
facility: Japanese Foundation for Cancer Research
city: Gdansk
country: Poland
facility: Medical University Gdansk
city: Lodz
country: Poland
facility: Polish Mother's Memorial Hospital - Research Institute
city: Poznan
country: Poland
facility: MED POLONIA SP Z O O, Clinical Trials Department,Poznan
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Lausanne
country: Switzerland
facility: University Hospital of Lausanne
Study officials:
References: