Trial Title:
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
NCT ID:
NCT05990738
Condition:
Small Cell Lung Carcinoma (SCLC)
Conditions: Official terms:
Small Cell Lung Carcinoma
Topotecan
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: BI 764532 high dose + single agent chemotherapy
Arm group label:
Part A: BI 764532 low dose + topotecan
Arm group label:
Part A: BI 764532 medium dose + single agent chemotherapy
Arm group label:
Part B: BI 764532 + topotecan
Other name:
Obrixtamig
Intervention type:
Drug
Intervention name:
Topotecan
Description:
Topotecan
Arm group label:
Part A: BI 764532 high dose + single agent chemotherapy
Arm group label:
Part A: BI 764532 low dose + topotecan
Arm group label:
Part A: BI 764532 medium dose + single agent chemotherapy
Arm group label:
Part B: BI 764532 + topotecan
Intervention type:
Drug
Intervention name:
Single agent chemotherapy
Description:
single agent chemotherapy
Arm group label:
Part A: BI 764532 high dose + single agent chemotherapy
Arm group label:
Part A: BI 764532 medium dose + single agent chemotherapy
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
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. 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. 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. 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. Patients must be eligible for single agent chemotherapy treatment (used in the
trial) according to label.
6. Availability of archival tumour tissue sample.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Further
inclusion criteria apply.
Exclusion Criteria:
1. Previous treatment in this trial.
2. Current enrolment in another investigational device or drug trial, or <30 days since
ending another investigational device or drug trial(s).
3. Untreated or symptomatic brain metastases. Participants with treated, stable brain
metastases are eligible provided they meet the following criteria:
- 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.
- 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.
4. Presence of leptomeningeal carcinomatosis.
5. Previous treatment with T cell engager (TcE) or cell therapies targeting delta-like
ligand 3 (DLL3).
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).
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.
8. Previous or concomitant malignancies other than the one treated in this trial within
the last 2 years except
1. effectively treated non-melanoma skin cancers
2. effectively treated carcinoma in situ of the cervix
3. effectively treated ductal carcinoma in situ
4. other effectively treated malignancy that is considered cured by local
treatment Further exclusion criteria apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
INS Curie
Address:
City:
Paris
Zip:
75005
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 Carl Gustav Carus Dresden
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Universitätsklinikum Erlangen
Address:
City:
Erlangen
Zip:
91054
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Address:
City:
Heidelberg
Zip:
69126
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Address:
City:
Mainz
Zip:
55131
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Universitätsklinikum Würzburg AÖR
Address:
City:
Würzburg
Zip:
97078
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@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:
Leicester Royal Infirmary
Address:
City:
Leicester
Zip:
LE1 5WW
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08000514022
Email:
unitedkingdom@bitrialsupport.com
Start date:
January 15, 2024
Completion date:
April 30, 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/NCT05990738
http://www.mystudywindow.com
