Trial Title:
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
NCT ID:
NCT06077500
Condition:
Small Cell Lung Carcinoma (SCLC)
Conditions: Official terms:
Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Carboplatin
Etoposide
Atezolizumab
Durvalumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BI 764532
Description:
BI 764532
Arm group label:
Part A - Dose escalation: BI 764532 high dose + carboplatin + etoposide + atezolizumab
Arm group label:
Part A - Dose escalation: BI 764532 low dose + carboplatin + etoposide + atezolizumab
Arm group label:
Part A - Dose escalation: BI 764532 medium dose + carboplatin + etoposide + atezolizumab
Arm group label:
Part A - Dose escalation: BI 764532 very low dose + carboplatin + etoposide + atezolizumab
Arm group label:
Part B - Dose expansion: BI 764532 + carboplatin + etoposide + atezolizumab
Arm group label:
Part B - Dose expansion: BI 764532 + carboplatin + etoposide + durvalumab
Arm group label:
Part B - Dose expansion: BI 764532 + cisplatin + etoposide + durvalumab
Other name:
Obrixtamig
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin
Arm group label:
Part A - Dose escalation: BI 764532 high dose + carboplatin + etoposide + atezolizumab
Arm group label:
Part A - Dose escalation: BI 764532 low dose + carboplatin + etoposide + atezolizumab
Arm group label:
Part A - Dose escalation: BI 764532 medium dose + carboplatin + etoposide + atezolizumab
Arm group label:
Part A - Dose escalation: BI 764532 very low dose + carboplatin + etoposide + atezolizumab
Arm group label:
Part B - Dose expansion: BI 764532 + carboplatin + etoposide + atezolizumab
Arm group label:
Part B - Dose expansion: BI 764532 + carboplatin + etoposide + durvalumab
Intervention type:
Drug
Intervention name:
Etoposide
Description:
Etoposide
Arm group label:
Part A - Dose escalation: BI 764532 high dose + carboplatin + etoposide + atezolizumab
Arm group label:
Part A - Dose escalation: BI 764532 low dose + carboplatin + etoposide + atezolizumab
Arm group label:
Part A - Dose escalation: BI 764532 medium dose + carboplatin + etoposide + atezolizumab
Arm group label:
Part A - Dose escalation: BI 764532 very low dose + carboplatin + etoposide + atezolizumab
Arm group label:
Part B - Dose expansion: BI 764532 + carboplatin + etoposide + atezolizumab
Arm group label:
Part B - Dose expansion: BI 764532 + carboplatin + etoposide + durvalumab
Arm group label:
Part B - Dose expansion: BI 764532 + cisplatin + etoposide + durvalumab
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
Atezolizumab
Arm group label:
Part A - Dose escalation: BI 764532 high dose + carboplatin + etoposide + atezolizumab
Arm group label:
Part A - Dose escalation: BI 764532 low dose + carboplatin + etoposide + atezolizumab
Arm group label:
Part A - Dose escalation: BI 764532 medium dose + carboplatin + etoposide + atezolizumab
Arm group label:
Part A - Dose escalation: BI 764532 very low dose + carboplatin + etoposide + atezolizumab
Arm group label:
Part B - Dose expansion: BI 764532 + carboplatin + etoposide + atezolizumab
Intervention type:
Drug
Intervention name:
Durvalumab
Description:
Durvalumab
Arm group label:
Part B - Dose expansion: BI 764532 + carboplatin + etoposide + durvalumab
Arm group label:
Part B - Dose expansion: BI 764532 + cisplatin + etoposide + durvalumab
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Cisplatin
Arm group label:
Part B - Dose expansion: BI 764532 + cisplatin + etoposide + durvalumab
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Orlando Health Cancer Institute
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Emory University
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Brussels - UNIV Saint-Luc
Address:
City:
Bruxelles
Zip:
1200
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
080049616
Email:
belgique@bitrialsupport.com
Facility:
Name:
Kortrijk - HOSP AZ Groeninge Kennedylaan
Address:
City:
Kortrijk
Zip:
8500
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
080049616
Email:
belgique@bitrialsupport.com
Facility:
Name:
INS Bergonie
Address:
City:
Bordeaux
Zip:
33000
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
HOP Louis Pradel
Address:
City:
Bron
Zip:
69677
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
HOP Civil
Address:
City:
Strasbourg
Zip:
67091
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
INS Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
Universitätsklinikum Gießen und Marburg GmbH
Address:
City:
Gießen
Zip:
35392
Country:
Germany
Status:
Suspended
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Tokyo, Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Japanese Foundation for Cancer Research
Address:
City:
Tokyo, Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Medical University Gdansk
Address:
City:
Gdansk
Zip:
80-214
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
008001218830
Email:
polska@bitrialsupport.com
Facility:
Name:
Polish Mother's Memorial Hospital - Research Institute
Address:
City:
Lodz
Zip:
93-338
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
008001218830
Email:
polska@bitrialsupport.com
Facility:
Name:
MED POLONIA SP Z O O, Clinical Trials Department,Poznan
Address:
City:
Poznan
Zip:
60-693
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
008001218830
Email:
polska@bitrialsupport.com
Facility:
Name:
Hospital Ramón y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Fundación Jiménez Díaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital Virgen Macarena
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Instituto Valenciano de Oncología
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
University Hospital of Lausanne
Address:
City:
Lausanne
Zip:
1011
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0800005900
Email:
suisse@bitrialsupport.com
Start date:
January 11, 2024
Completion date:
June 25, 2026
Lead sponsor:
Agency:
Boehringer Ingelheim
Agency class:
Industry
Source:
Boehringer Ingelheim
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06077500
https://www.mystudywindow.com
