Trial Title:
DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers
NCT ID:
NCT05882058
Condition:
Small Cell Lung Carcinoma
Neuroendocrine Neoplasms
Conditions: Official terms:
Carcinoma
Small Cell Lung Carcinoma
Neuroendocrine Tumors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BI 764532, formulation 1
Description:
BI 764532, formulation 1
Arm group label:
Dose group 1
Arm group label:
Dose group 2
Other name:
Obrixtamig
Intervention type:
Drug
Intervention name:
BI 764532, formulation 2
Description:
BI 764532, formulation 2
Arm group label:
Dose group 1
Arm group label:
Dose group 2
Other name:
Obrixtamig
Summary:
This study is open to adults with small cell lung cancer and other neuroendocrine
tumours. The study is in people with advanced cancer for whom previous treatment was not
successful or no standard treatment exists.
The purpose of this study is to find a suitable dose of BI 764532 that people with
advanced cancer can tolerate when taken alone. 2 different doses of BI 764532 are tested
in this study. Another purpose is to check whether BI 764532 can make tumours shrink. BI
764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system
fight cancer.
Participants are put into 2 groups randomly, which means by chance. One group gets dose 1
of BI 764532 and the other group gets dose 2 of BI 764532. Participants get BI 764532
infusions into a vein when starting treatment. If there is benefit for the participants
and if they can tolerate it, the treatment is given up to the maximum duration of the
study. During this time, participants visit the study site regularly. The total number of
visits depends on how they respond to and tolerate the treatment. The first study visits
include an over-night stay to monitor participants' safety. Doctors record any unwanted
effects and regularly check the general health of the participants.
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 Council
for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to
admission to the trial.
3. Histologically or cytologically confirmed, cancer of the following histologies:
- Small cell lung cancer (SCLC)
- Extra-pulmonary neuroendocrine carcinoma (epNEC) (except Merkel cell carcinoma
(MCC), Medullary thyroid cancer (MTC) and Neuroendocrine prostate cancer
(NEPC))
- Large cell neuroendocrine carcinoma (LCNEC) of the lung Patients with tumours
with mixed histologies for any above type are eligible only if the
neuroendocrine carcinoma/small tumour cells component is predominant and
represents at least 50% of the overall tumour tissue.
Patients must have progressed or recurred after standard of care therapy
- SCLC: after at least two prior lines of therapy, including at least one
platinum-based regimen; in countries where standard of care in first line
therapy includes PD-L1 inhibitor treatment patients should have received the
combination of platinum-based regimen plus PD-L1 inhibitor unless they have
been unable to receive checkpoint inhibitor treatment.
- epNEC/LCNEC: after at least one platinum-based regimen
4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
5. Measurable lesions as defined per Response Evaluation Criteria In Solid Tumours
(RECIST) v 1.1 within 21 days prior to the first dose of BI 764532.
6. Availability of archival tumour tissue sample.
7. Adequate organ function as defined in the protocol.
8. All toxicities related to previous anti-cancer therapies have resolved = Common
Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to trial treatment
administration (except for alopecia, peripheral neuropathy, fatigue and
endocrinopathies controlled by replacement therapy which must be = CTCAE Grade 2 and
amenorrhea/menstrual disorders which can be any grade).
9. Women of childbearing potential (WOCBP)and men able to father a child must be ready
and able to use highly effective methods of birth control per ICH M3 (R2) that
result in a low failure rate of less than 1% per year when used consistently and
correctly. A list of contraception methods meeting these criteria and instructions
on the duration of their use is provided in the participant information
Exclusion criteria:
1. Untreated or symptomatic brain metastases. Participants with treated, stable brain
metastases are eligible provided they meet the following criteria:
- Radiotherapy or surgery for brain metastases was completed at least 2 weeks
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.
2. Presence of leptomeningeal disease.
3. Active/previous history of interstitial lung disease or non-infectious pneumonitis
(any grade).
4. Participants who experienced severe, life-threatening immune-mediated adverse events
or infusion-related reactions including those that lead to permanent discontinuation
while on treatment with immuno-oncology agents.
5. Prior anti-cancer therapy:
- Patients who have been treated with any other anti-cancer drug within 4 weeks
or within 5 half-life periods (whichever is shorter) prior to first
administration of BI 764532.
- Patients who have been treated with extensive field radiotherapy including
whole brain irradiation within 2 weeks prior to first administration of BI
764532.
6. Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers or cell
therapies.
7. Diagnosis of immunodeficiency or systemic steroid therapy or any other form of
immunosuppressive therapy within 7 days prior to the first dose of BI 764532.
Physiological replacement of steroids is allowed.
8. Unresolved toxicity from prior anti-tumour therapy, defined as per protocol. Further
exclusion criteria apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Infirmary Cancer Care
Address:
City:
Mobile
Zip:
36607
Country:
United States
Facility:
Name:
Mayo Clinic-Arizona
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Facility:
Name:
Valkyrie Clinical Trials
Address:
City:
Los Angeles
Zip:
90067
Country:
United States
Facility:
Name:
University of California San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Facility:
Name:
Mayo Clinic Cancer Center
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Facility:
Name:
Indiana University
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Facility:
Name:
Kansas University Medical Center
Address:
City:
Fairway
Zip:
66205
Country:
United States
Facility:
Name:
University of Kentucky Medical Center
Address:
City:
Lexington
Zip:
40536
Country:
United States
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Facility:
Name:
Mayo Clinic, Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Facility:
Name:
Montefiore Medical Center
Address:
City:
Bronx
Zip:
10461
Country:
United States
Facility:
Name:
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Facility:
Name:
UNIV UZ Gent
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Facility:
Name:
MHAT UniHospital
Address:
City:
Panagyurishte
Zip:
4500
Country:
Bulgaria
Facility:
Name:
MHAT Heart and brain
Address:
City:
Pleven
Zip:
5800
Country:
Bulgaria
Facility:
Name:
West China Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Facility:
Name:
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Facility:
Name:
Qilu Hospital, Shangdong University
Address:
City:
Jinan
Zip:
250012
Country:
China
Facility:
Name:
960 Hospital of the Chinese People's Liberation Army
Address:
City:
Jinan
Zip:
250031
Country:
China
Facility:
Name:
The Second Affiliated Hospital to Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Facility:
Name:
HOP Intercommunal
Address:
City:
Créteil
Zip:
94000
Country:
France
Facility:
Name:
HOP Cochin
Address:
City:
Paris
Zip:
75014
Country:
France
Facility:
Name:
HOP Civil
Address:
City:
Strasbourg
Zip:
67091
Country:
France
Facility:
Name:
Evangelische Lungenklinik Berlin
Address:
City:
Berlin
Zip:
13125
Country:
Germany
Facility:
Name:
Universitätsklinikum Carl Gustav Carus Dresden
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Facility:
Name:
Universitätsklinikum Erlangen
Address:
City:
Erlangen
Zip:
91054
Country:
Germany
Facility:
Name:
Asklepios Fachkliniken München-Gauting
Address:
City:
Gauting
Zip:
82131
Country:
Germany
Facility:
Name:
LungenClinic Grosshansdorf GmbH
Address:
City:
Großhansdorf
Zip:
22927
Country:
Germany
Facility:
Name:
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Address:
City:
Mainz
Zip:
55131
Country:
Germany
Facility:
Name:
Aichi Cancer Center Hospital
Address:
City:
Aichi, Nagoya
Zip:
464-8681
Country:
Japan
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Chiba, Kashiwa
Zip:
277-8577
Country:
Japan
Facility:
Name:
Sendai Kousei Hospital
Address:
City:
Miyagi, Sendai
Zip:
980-0873
Country:
Japan
Facility:
Name:
Kindai University Hospital
Address:
City:
Osaka, OsakaSayama
Zip:
589-8511
Country:
Japan
Facility:
Name:
Osaka International Cancer Institute
Address:
City:
Osaka, Osaka
Zip:
541-8567
Country:
Japan
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Tokyo, Chuo-ku
Zip:
104-0045
Country:
Japan
Facility:
Name:
Japanese Foundation for Cancer Research
Address:
City:
Tokyo, Koto-ku
Zip:
135-8550
Country:
Japan
Facility:
Name:
Severance Hospital
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Facility:
Name:
Hospital CUF Descobertas
Address:
City:
Lisboa
Zip:
1350-352
Country:
Portugal
Facility:
Name:
Hospital CUF Porto
Address:
City:
Porto
Zip:
4100-180
Country:
Portugal
Facility:
Name:
Hospital del Mar
Address:
City:
Barcelona
Zip:
08003
Country:
Spain
Facility:
Name:
Hospital Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Facility:
Name:
Hospital Virgen de la Victoria
Address:
City:
Malaga
Zip:
29010
Country:
Spain
Facility:
Name:
Hospital Clínico de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Facility:
Name:
NCKUH
Address:
City:
Tainan
Zip:
704
Country:
Taiwan
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Facility:
Name:
Chang Gung Memorial Hospital(Linkou)
Address:
City:
Taoyuan County
Zip:
333
Country:
Taiwan
Facility:
Name:
Leicester Royal Infirmary
Address:
City:
Leicester
Zip:
LE1 5WW
Country:
United Kingdom
Facility:
Name:
University College Hospital
Address:
City:
London
Zip:
WC1E 6AG
Country:
United Kingdom
Facility:
Name:
Freeman Hospital
Address:
City:
Newcastle Upon Tyne
Zip:
NE7 7DN
Country:
United Kingdom
Start date:
September 25, 2023
Completion date:
July 3, 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/NCT05882058
https://www.mystudywindow.com
